Neoplasms

All Conditions

Rare Diseases

Pheochromocytoma

Paraganglioma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Paragangliomas 1

Neuroendocrine Tumor

Neuroepithelioma

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Antihypertensive Agents

Nitric Oxide Donors

Vasodilator Agents

Dexmedetomidine

Nitroprusside

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Not receive perioperative additional medication.

Received oral 300 mg magnesium one week before surgery and magnesium-dexmedetomidine combination perioperatively.

Received oral 300 mg magnesium one week before surgery and magnesium-dexmedetomidine combination perioperatively

Magnesium-Dexmedetomidine

Nükhet Sivrikoz, MD

Anesthesia management of pheochromocytoma excision surgery is associated with severe hemodynamic fluctuations.The objective of this study was to compare the hypertensive episodes requiring sodium nitroprusside administration between the group treated with magnesium-dexmedetomidine and conventional group in pheochromocytoma.

Magnesium and Dexmedetomidine in Pheochromocytoma

Magnesium and Dexmedetomidine Combination Reduces Sodium Nitroprusside Requirement in Laparoscopic Pheochromocytoma

intraoperative hypertensive episodes requiring SNP therapy

hemodynamic fluctuations (hypotension, tachycardia, severe hypertensive crisis) which needed vasoactive therapy.

Istanbul University

Attending Anesthesiologist

Heart and Blood Diseases

Hypotension

Vascular Diseases

Hemodinamic monitoring with HPI working with ClearSight

Hemodinamic monitoring with classic ClearSight

treatment of hypotension before the appearance following HPI algorithm

Hypotension Prediction Index

Background Intraoperative hypotension is associated with increased morbidity and mortality. The Hypotension Prediction Index (HPI) is an advancement of the arterial waveform analysis to predict intraoperative hypotension minutes before episodes occur enabling preventive treatments.

This study will test the hypothesis that a hemodynamic treatment protocol based on HPI working with non-invasive ClearSight system reduces intraoperative hypotension when compared to standard goal directed therapy (GDT) in patients undergoing gynaecologic oncologic surgery.

Methods A retrospective analysis of 68 adult consecutive patients undergoing gynaecologic oncologic surgery with non-invasive arterial pressure monitoring using either index guidance (HPI) or classic ClearSight system waveform analysis depending on availability (ClearSight, n = 36; HPI, n = 32) will be conducted. A hemodynamic GDT protocol was applied in both groups. The primary endpoint will be the incidence and duration of hypotensive events defined as MAP \<65 mmHg evaluated by time-weighted average of hypotension.

INTRODUCTION Intraoperative hypotension (IOH) is a common adverse event during noncardiac surgery \[1,2\]. It is associated with an increased incidence of acute kidney injury, myocardial injury, neurological deficiencies, as well as an increased 30-day operative mortality \[3-7\]. Organ injuries were shown to be associated with the depth, frequency, and duration of hypotensive episodes \[4,8\]. Data indicate that a mean arterial pressure of 65 mmHg serves as a threshold to predict myocardial and kidney injury \[9-11\].

Recently developed minimally invasive methods of the arterial waveform analysis allow calculation of cardiac output, stroke volume, stroke volume variation, and systemic vascular resistance. This deeper insight into hemodynamics enables goal-directed therapy approaches; however, the given information only allows to react to events instead of preventing them \[12,13\].

Interestingly, recent data indicate a significant reduction in postoperative organ dysfunction by preventing IOH, suggesting a potential benefit of early intervention \[14\].

Surgical interventions for cancer mass reduction are among the most invasive operations in gynaecology. Extensive surgical trauma results in severe intra- and perioperative volume shifts and unstable hemodynamics \[15\]. Major abdomino-pelvic surgery for gynaecological oncologic surgery (GOS) may include hysterectomy, oophorectomy, omentectomy, colectomy, removal of the lymph nodes and peritoneal stripping. Surgery is carried out through laparoscopy or a laparotomic incision and is often associated with significant blood loss \[16\]. Hypotension during GOS is common, and as it is associated with the potential for harm, it requires prompt evaluation and treatment \[16\]. Extensive fluid resuscitation in peritoneal cancer patients is associated with a poor postoperative outcome independent from the underlying malignant disease and avoiding fluid overload is recommended \[15\].

Therefore, the prediction of intraoperative hypotension and consequently its prevention by proactive treatment may show beneficial effects for patients. Machine learning, a discipline within computer science used to analyse large data sets and to develop predictive models, has evident applications in health care \[17,18\]. Several attempts to use algorithms as an aid in anaesthesiology practice recently received renewed attention, with the aim of optimizing patients' perioperative status, primarily focusing on detection of early hemodynamic instability and prediction of hypotension \[19\].

The Hypotension Prediction Index - HPI (Edwards Lifesciences, Irvine, USA) is an algorithm based on the complex analysis of features in high fidelity arterial pressure waveform recordings developed to observe subtle signs that could predict the onset of hypotension in surgical and intensive care unit patients \[20\]. HPI is a unitless number that ranges from 1 to 100, and as the number increases, the likelihood or risk of a hypotensive event (defined as a mean arterial pressure \[MAP\] \<65 mmHg for more than 1 minute) occurring in the near future increases \[20\]. A validation study conducted on surgical patients reported high sensitivity and specificity of HPI for predicting hypotension 5, 10 and 15 min before the event occurred \[21\]. The development of the algorithm was based on invasive arterial line waveform data; however, only a small fraction of patients having noncardiac surgery requires invasive arterial monitoring \[22\].

Estimation of arterial pressure waveforms from a non-invasive finger cuff (ClearSight) is well established, and MAP measured by ClearSight system could be considered as an alternative for mean radial arterial pressure \[23,24\]. The HPI algorithm, is recently reported to work also with a non-invasive waveform estimate \[25-27\].

This study will compare a hemodynamic management based on the HPI algorithm working with non-invasive ClearSight system with a classic ClearSight-based one in terms of incidence, duration, and severity of intraoperative hypotensive events evaluated by time-weighted average of hypotension in patients undergoing GOS.

MATERIALS AND METHODS This single-center retrospective observational study was approved by the Internal Ethics Committee (ID 3664, protocol number 10077/21). Written informed consent will be obtained from all the patients involved.

The primary endpoint is the incidence, duration, and severity of hypotensive events (defined as MAP \< 65 mmHg for at least 1 minute) evaluated by time-weighted average (TWA) MAP of hypotension in the two groups of patients. The TWA-MAP is a combination of severity and duration of the hypotensive events, in relation to the total surgery time. It is calculated by using the sum of the area under the threshold divided by the duration of surgery \[28\]. The threshold for hypotensive events is defined as a MAP below 65 mmHg for at least 1-min duration. Hypotension duration time ends after re-increasing MAP values upon ≥65 mmHg for at least 1 min.

Secondary endpoints consists of number of patients with hypotensive events, number of events per (respective) patient, cumulative and average duration of hypotension, combined with numbers of hypotensive events \<65 and \<50 mmHg.

The data were collected during a limited period of time in which new hemodynamic monitoring sensors (ClearSight) were evaluated during a time marketing release. The first 68 patients undergoing GOS at IRCCS Policlinico A.Gemelli Foundation between December 2019 and February 2020 were monitored either with classic ClearSight sensor (n= 36) and ClearSight sensor with HPI-enabled (n = 32). Inclusion criteria consisted of elective GOS, age \>18 years. Exclusion criteria were patients not in sinus rhythm, ejection fraction \<30%, severe aortic valve stenosis, emergency surgery, acute myocardial ischemia, pregnancy.

Standard monitoring (Life Scope TR, Nihon Kohden Co, Tokyo, Japan) included a 5-lead electrocardiogram, pulse oximetry, non-invasive blood pressure (NIBP) and eventual invasive blood pressure (IBP). In addition to standard monitoring, all patients had a non-invasive hemodynamic monitoring with ClearSight (Edwards Lifesciences, Irvine, CA). After arriving at the operating theatre, NIBP measurement using an automated digital sphygmomanometer on the right arm was started and the ClearSight system was attached to a finger of the left arm of the patients. We connected the ClearSight monitor with an interface cable to the patient monitor. In patients requiring IBP monitoring an arterial cannula was placed contralateral to the ClearSight cuff. The ClearSight reference system was zeroed at the level of the right atrium. The blood pressure value from the finger cuff (CS-BP) was reported on the main monitor. NIBP measurement using the automated digital sphygmomanometer was performed at 5-min intervals. For therapy purposes we defined hypotension as an absolute value of CS-BP MAP \< 65 mmHg. Incidence and duration of hypotensive episodes and interventions were registered. Bradycardia was defined as a heart rate (HR) \< 60 bpm.

A large bore i.v. catheter was inserted in a forearm vein, and Cefazoline 2 gr, Dexamethasone 4 mg and Omeprazole 40 mg were administered. General anesthesia was induced with sufentanil 0.2 mcg/kg (ideal body weight), propofol 2 mg/kg (actual body weight), and rocuronium 0.6 mg/kg (ideal body weight). During surgery, patients were positioned in Trendelenburg position with both arms spread out on arm-positioning devices. Anesthesia was maintained with Sevoflurane to maintain a Bispectral Index value between 40-50. Additional boluses of sufentanil and rocuronium were administered when needed.

All patients received a GDT hemodynamic protocol to optimize the cardiac output and oxygen supply. As part of the GDT protocol, patients received crystalloid and/or fluids to maintain SVV\<13% or to avoid SV decrease of more than 10% of the baseline. Vasopressor and inotropic medication were administered upon request of the clinician in order to maintain a MAP ≥65. In the HPI group, the attending anesthesiologist was free to use liquid, vasopressors and inotropic drugs, but he was allowed to read on the Hemosphere monitor HPI and secondary parameters (for evaluation of preload, cardiac contractility, and afterload as possible causes for hypotension), and to act in a preventive way in order to avoid hypotension.

All data were downloaded from the HemoSphere monitor, including HPI, CS-MAP, CS systolic arterial pressure, CS diastolic arterial pressure. All downloaded data consisted of 20-second interval averaged data points. Data were transferred to a computer for analysis via an USB drive. Every file was appointed with an automated generated code by the machine and was identifiable by an ID number contained within it.

The HPI algorithm estimates the probability of occurrence in the near future of a hypotensive event taking the arterial pressure waveform as the input to compute an index value that ranges between 1 and 100. In this study, instead of invasive arterial waveform data, we used the non-invasive arterial pressure waveform of ClearSight.

In the HemoSphere monitor, poor quality arterial waveforms were automatically detected by the arterial waveform processing algorithms and excluded from the computation of the 20-sec averages.

Statistical analysis Data collected perioperatively and downloaded from the HemoSphere platform will be analyzed using the Acumen Analytics Software (Edwards Lifesciences Corp.).

Categorical data will be presented as frequencies with percentages. Differences will be analyzed with the Fisher's exact test. For quantitative variables test for normal distribution with the Shapiro-Wilk test will be used. Data will be presented as means ±standard deviation (SD) in case of normally distribution, otherwise, as median and interquartile range (IQR). Linear variables will be analyzed using the Student's unpaired t-test in normal distributed variables and the Mann-Whitney U-test in non-normally distributed variables. P-values less than 0.05 will be considered statistically significant. Statistical analysis will be performed with SPSS Statistics.

Perioperative Hypotension in Gynaecologic Oncologic Surgery: HPI-ClearSight Versus Arterial Waveform Analysis

Non-Invasive Hemodynamic Monitoring and Incidence of Perioperative Hypotension in Gynaecologic Oncologic Surgery: Hypotension Prediction Index Working With ClearSight Versus Arterial Waveform Analysis Alone

Comparison, in the two groups, of the amount of intraoperative hypotension (MAP \< 65 mmHg), measured with TWAMAP method.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Nervous System Diseases

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Pharmaceutical Solutions

Group D: Patients received 0.5 µg/kg/h of Dexmedetomidine. Dexmedetomidine dosage was diluted in 50 ml syringe of normal saline

Patients received equal volume and rate of normal saline as Group D.

On the scheduled time of operation, the head nurse opened each envelope just before surgery, prepared the infusion solution and handled it to the anesthesiologist who was blinded to the solution. He was then determined for collecting perioperative data.

Group D: Patients received 0.5 µg/kg/h of Dexmedetomidine. Dexmedetomidine dosage was diluted in 50 ml syringe of normal saline Group C: Patients received equal volume and rate of normal saline as Group D.

This dosing regimen was in accordance with existing guidelines \[5\] \[6\] \[7\].

On the scheduled time of operation, the head nurse opened each envelope just before surgery, prepared the infusion solution and handled it to the anesthesiologist who was blinded to the solution. He was then determined for collecting perioperative data.

Group C: Patients received equal volume and rate of normal saline as Group D.

normal saline

There is no clear consensus among neuroanesthesiologists regarding which anesthetic regimen is optimal for craniotomy. Propofol and short-acting opioids (such as remifentanil, fentanyl, or sufentanil) are commonly used. However, use of opioids is associated with increased risk of respiratory depression and postoperative nausea and vomiting. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist that has been considered as a useful and safe adjunct to anesthesia for various surgical procedures

The investigators designed this randomized, double-blind study to evaluate the effectiveness of administration of Dexmedetomidine infusion at a dose of 0.5 µg/kg/h without loading dose during elective supratentorial craniotomy under GA. The investigators will compare intraoperative hemodynamics in both groups, intraoperative analgesic consumption, intraoperative blood loss, postoperative sedation scores, intraoperative need for rescue hypotensive agents, and finally the satisfaction of surgeons.

To our knowledge, the present study is the first to evaluate the effect of Dexmedetomidine infusion without loading dose in elective supratentorial craniotomy

Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy

Efficacy of Dexmedetomidine Infusion Without Loading Dose on Hemodynamic Variables and Recovery Time During Craniotomy: A Randomized Double Blinded Controlled Study

The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.

incidence of intraoperative hemodynamic stability

Recovery time in minutes (time interval between discontinuation of isoflurane and extubation).

Assessment of postoperative sedation level using "University of Michigan Sedation Scale (UMSS)" The UMSS is a simple observational tool that assesses the level of alertness on a five-point scale ranging from 1 (wide awake) to 5 (unarousable with deep stimulation). Score: 1- 5

Ain Shams University

Assistant Professor of Anesthesia

Vasoconstrictor Agents

Cardiac optimization with goal-directed therapy, liberal use of vasopressor agents.

Hemodynamic management HPI-based, protocol-based use of fluids, vasopressors and inotropes.

HPI - hypotension prediction index

cardiac optimization and treatment of hypotension following standard clinical practice

Gaetano Draisci, MD

Luciano Frassanito, MD

Intraoperative hypotension (IOH) is a rather common event during general surgery, with variable incidence that ranges between 5 and 99% based on the definition used. It is associated to significant complications including acute renal failure, myocardial damage, stroke and overall increased mortality, reason why the prevention and the reduction of hypotensive events through an appropriate proactive approach can potentially improve the patient's outcome. The Hypotension Prediction Index (HPI) is an algorithm derived from the analysis of the arterial waveform and it is expressed as an absolute value from 0 to 100. It has been demonstrated that the HPI is able to predict the occurrence of hypotensive events of patients undergoing major surgery under general anesthesia, providing also a guide for the appropriate treatment based on further calculated secondary hemodynamic variables that estimate patient's preload, cardiac contractility and afterload. Aim of this prospective randomized study is to compare the incidence of IOH during major gynecologic oncologic surgery among two groups of patients receiving standard hemodynamic monitoring versus HPI monitoring. The primary hypothesis is that hemodynamic management HPI-guided reduces the incidence, entity and duration of intraoperative hypotensive events, defined as mean arterial pressure (MAP) lower than 65 mmHg lasting more than one minute.

Intraoperative hypotension (IOH) represents a common event during general anesthesia (GA), with an estimated incidence between 5% and 99%, according to definition adopted \[1\].

Actually, a mean arterial pressure (MAP) below 65 mmHg is considered an appropriate definition of IOH \[2\].

Hypotension mainly occurs during anaesthesia due to three pathophysiological dysregulations: hypovolemia and consecutively decreased cardiac output, myocardial depression and low systemic vascular resistance \[3\]. IOH has been associated with postoperative acute acute kidney injury and myocardial injury; it seems that the cumulative time spent in hypotension increases the risk, and this has implications as even relatively short episodes of hypotension that are treated promptly can over time reach accumulated hypotension time associated with increased injury rates \[4-7\]. Therefore, anaesthetic management that aims to prevent IOH using a "pro-active" treatment protocol might potentially reduce the amount and severity of IOH, perioperative complications and mortality. In order to detect and treat these haemodynamic alterations, advanced haemodynamic monitoring combined with a treatment algorithm can be used \[8\].

The Hypotension Prediction Index (HPI) algorithm was recently established by Edwards Lifesciences (Irvine, USA). Based on the Edward´s monitoring platform (HemoSphere), HPI is a monitoring tool which aims to predict IOH up to 15 min before its onset \[9, 10\]. HPI is a unitless number that ranges from 1 to 100, and as the number increases, the risk of an event occurring in the future increases. The HPI was developed using machine learning methods and is a data-driven model developed from over 200,000 hypotensive patient events and it predicts upcoming hypotensive events based on features of the arterial pressure waveform \[9\].

When HPI rises over 85, the monitor Hemosphere provides a secondary screen showing the following hemodynamic parameters: stroke volume variation (SVV) as indicator of fluid responsiveness - preload, radial dP/dtmax as indicator of cardiac contractility, and dynamic elastance (Eadyn) as dynamic indicator of resistance - afterload. Hemodynamic variables, hemodynamic diagnostic guidance and the definition of a treatment protocol, should allow for determination and treatment of the underlying cause of the impending hypotension.

Using an early warning system to predict hypotension does not necessarily lead to reduce hypotension. There are few randomized clinical trials to investigate the effectiveness of the use of HPI in reducing the amount of hypotension as measured by time-weighted average \[11\] during major noncardiac surgery \[3, 12\].

Eligible patients will be allocated in one of the two groups of the study according to a computerized randomization form (ww.randomization.com). Once the patient arrives in the premedication hall of the operating room, a peripheral intravenous access will be placed. Based on the patient's allocation group, the following hemodynamic monitoring will be started:

* Group C - Control: through the EV1000 monitor (with Flotrac sensor)
* Group HPI - Proactive: through the HemoSphere platform (with Acumen Flotrac sensor)

The following timepoints will be recorded:

T0: Machine calibration on the bed in neutral position, recordings of the parameters with annotation of the baseline MAP; T1: Infusion of RLS at 3ml/kg/h as in standard clinical practice; T2: cannulation of the radial artery under local anesthesia before induction of general anesthesia, as in normal standard clinical practice; T3: performance of neuraxial anesthesia if needed; T4: standard induction of general anesthesia GA) with propofol, sufentanil and rocuronium bromide; maintenance of GA with sevoflurane and sufentanil; T5: differentiated hemodynamic management based on the patient's allocation group; T6: surgery under continuous monitoring.

Group C: Standard Protocol In group C the hemodynamic management will be performed based on cardiac optimization. Fluid boluses will be given with the use of an individualized goal-directed therapy (GDT) protocol aiming to optimize stroke volume index (SVI) \[13\]. Patients will receive 250 ml fluid challenges, within duration of 5 minutes, with a RL solution. Fluid responsiveness will be defined as a SVI increase ≥10%. Maximal stroke volume will be defined as the absence of a sustained rise in SVI of at least 10% sustained for 20 minutes or more in response to a fluid challenge. No more than 500 ml of fluid will be administered for initial determination of the maximal value of SVI before start of the surgical procedure. Once the maximal value of SVI will be determined after induction of anesthesia, SVI must be maintained throughout the intervention period with subsequent boluses of fluids as required.

For the treatment of eventual hypotensive episodes, etilephrine or efedrine will be used, depending on the clinical situation. If needed, continuous infusion of noradrenaline and/or other vasopressors or inotropes will be started.

All of the hemodynamic parameters detected with the EV1000 monitor and the measures adopted will be recorded.

Group HPI: Proactive Protocol In case of HPI\>85, hypotension will be prevented according to the following modalities. The first step will be the optimization of SVV (in case of SVV\>13%) with bolus of 250 ml RLS. In case of dP/dtmax \< 400 (or in decreasing trend) dobutamine infusion 2.5 - 5 mcg/Kg/min will be started. In case of Eadyn \< 0,9 norepinephrine infusion 0,1 mcg/kg/min will be started.

All of the data relative to the hemodynamic monitoring and the measures adopted will be recorded and subsequently analyzed to compare the incidence and duration of the hypotensive events in the 2 groups. To calculate the entity of the intraoperative hypotension the following technique will be used: after removal of artifacts, the TWA MAP (time weighted average mean arterial pressure) \<65mmHg will be represented by the area between the threshold of 65 mmHg and the curve of the measured MAP, divided by the total recorded time in minutes \[12\].

Statistical plan The data will be described in their demographic and clinical characteristics through the application of descriptive statistics. The qualitative variables will be described using tables of absolute frequencies and percentages; the continuous quantitative variables will be presented as a median and interquartile range or as a mean and standard deviation when normally distributed; while the non-normal variables will be presented as minimum, maximum and median values.

In the two groups of patients, the hypertensive events, defined as a MAP lower than 65mmHg for \> 1 minute (and the severe hypotensive events as having a MAP lower than 60 and 55 mmHg), will be analyzed in terms of frequency and absolute duration and, to estimate their severity, as the ratio between the area under the 65 mmHg threshold and the total length, expressed in minutes, of intraoperative monitoring using the TWA-MAP method. The Chi-squared test will be used to compare the two incidences. The t-student test for independent samples will be used to evaluate statistically significant differences among the patients' demographic and anthropometric characteristics.

The Shapiro-Wilk test will be used to assess the normality of data distribution, while the sd test will be used to verify the equality of the variance.

The Mann-Whitney test will be used for independent samples to compare the data that are not normally distributed.

Regarding the assessment of the secondary outcomes, the investigators will report the relative risks with 95% confidence intervals and p-values based on either the chi square or Fisher's exact test, as more appropriate according to the frequencies expected and detected.

A p-value \<0.05 will be considered statistically significant. All of the analysis will be performed through the STATA IC 15.1 (Stata Corp) for Windows, Microsoft Excel, Matlab (The MathWorks Inc., Natick, MA, USA) and the Acumen Analytics software (Edwards Lifesciences, Irvine, CA).

Sample Size International literature agrees to consider clinically significant a reduction of 75% of the hypotensive events in terms of entity and duration. According to one of our internal databases (data not yet published), the mean TWA-MAP during gynecological oncology surgery is 0,5 mmHg. Thus, the estimated mean difference between the two groups according to the sample size calculations results to be 0.38 mmHg. Based on the previous clinical trials 11,12 the TWA-MAP standard deviation is estimated to be 0.51 mmHg. Dividing the mean difference by the standard deviation, the resulting dimension has a size effect of 0.74. The investigators calculated that a sample of 60 patients, 30 for each group, has 80% ability of discriminating such effect (t-test with α of 0.05).

Hypotension Prediction With HPI Algorithm During Major Gynecologic Oncologic Surgery

Hemodynamic Monitoring and Prediction of Hypotension Through the HPI Algorithm During Major Gynecologic Oncologic Surgery: a Randomized Controlled Trial

Comparison, in the two groups, of the amount of intraoperative hypotension (MAP \< 65 mmHg), measured with TWA-MAP method.

Comparison, in the two groups, of the amount of hypotension (MAP \< 65 mmHg) anesthesia induction related, measured with TWA-MAP method.

Comparison, in the two groups, of the amount of severe intraoperative hypotension (MAP \< 60 mmHg), measured with TWA-MAP method.

Comparison, in the two groups, of the incidence of acute kidney injury, myocardial ischemia, delirium and death.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ascites

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

3 Liters are drained, then the drain is clamped and the rest of the ascites is drained on the next day

Full versus partial paracentesis (3 liters)

Paracentesis

Klaus Pietzner, MD

The ATLANTIS-study was designed to determine the safety of a full paracentesis in patients with malignant ascites due to ovarian cancer. The underlying hypothesis states, that full paracentesis does not impair safety, compared to fractioned paracentesis with clamping of the drain. Half of the patients will receive a full paracentesis, while the other half will receive fractioned paracentesis with clamping of the drain after 3 liters of ascites was evacuated. All patients receive extensive monitoring of hemodynamics and kidney function.

Background: Malignant ascites is common in ovarian cancer and often causes symptoms such as abdominal pressure and shortness of breath, resulting in an decreased quality of life for the patient. Paracentesis is a safe and easy method for symptom relief. But no guidelines exist on the management of ascites drainage in ovarian cancer. In many cases a partial paracentesis is performed, due to fear of hemodynamic instability or kidney failure, with partial drainage of the intraperitoneal fluid on the first day and subsequent drainage on the next day. As there is no study that reported a deteriorated health due to full paracentesis in ovarian cancer, the decision whether a partial or total paracentesis is performed depends entirely on the department or the physician.

Since a total paracentesis can be performed as an out-patient treatment, this approach is often preferred by the patient. Full paracentesis is also more efficient and cost-effective.

The objective of the ATLANTIS-study is to prove the safety of total paracentesis regarding hemodynamic changes and kidney failure.

Methods: ATLANTIS is a randomized, prospective, clinical study that aims to include 60 patients. Patients with histologically confirmed epithelial ovarian, fallopian tube and peritoneal cancer are randomized into two arms: Partial (3 Liter) and total paracentesis. Before, during and for two hours after the paracentesis, an advanced hemodynamic monitoring is performed to ensure the patients' safety. The monitoring includes mean arterial pressure and stroke volume. After the initial phase of extensive monitoring (2 hours), the blood pressure is measured for a period of 24 hours to evaluate not only short term, but also long-term hemodynamic changes. Before and 24 hours after the paracentesis, blood samples are analyzed to detect a potential acute kidney failure.

Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics

Stroke volume is measured by advanced hemodynamic monitoring

Mean arterial pressure is measured by advanced hemodynamic monitoring

Incidence of hypotension (medical intervention indicated) and impairment of kidney function (KIDIGO criteria)

Measurement in plasma (Blood count, creatinin, AST, ALT, urea, aldosterone, renin, sodium, potassium, albumin, C-reactive protein, leukocytes)

Measured with the EuroQuol-Group 5 Dimensions - Visual analog scale (EQ-5D VAS) questionnaire, the questionnaire directs to characterize the quality of life by mobility, activities, pain and fear and subjective scale between 1 (worst) and 100 (best)

Measured with the and Functional Assessment of Chronic Illness Therapy-Ascites Index (FACIT-AI) questionnaire, the questionnaire directs to characterise the symptoms associated to ascites regarding 13 factors e.g. appetite, sleep, activities, symptoms, emotional distress by 0 to 4 points. The maximum score is 52 (best result: 13x4), 0 is the minimum score (worst result 13x0)

Measurement of exact drainage volume in millilitre

Measurement of the concentration of hormone vascular endothelial growth factor in ascites

Venous return and mean systemic filling pressure is measured by advanced hemodynamic monitoring

Charite University, Berlin, Germany

Principal Investigator, Consultant of Gynaecological Oncology

Eye Diseases

Diseases and Abnormalities at or Before Birth

Retinoblastoma

Neoplasms, Neuroepithelial

Retinal Neoplasms

Eye Neoplasms

Eye Diseases, Hereditary

Retinal Diseases

Anti-Arrhythmia Agents

Channel Blockers

Lidocaine

Anesthetics

Tetracaine

Proxymetacaine

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Topical ophthalmic anesthesia to participants (#) on each session (letter) of intra-arterial chemotherapy.

where #1 is the participant identifier and letter-a is the start session with study protocol (most candidates will receive more than 4 sessions in a 6 month period)

One drop of 0.5% Proparacaine to nasolacrimal Duct to numb the ethmoidal nerve in the nasal passage on the side of the eye to be treated.

Tetracaine 0.5%

1ml of lidocaine gel is placed over the conjunctivae of the eye to be treated after the patient is under general anesthesia and before the procedure

Lidocaine hydrochloride ophthalmic gel 3.5%

Jacqueline Tutiven, MD

Norman Halliday, MD

The objective of this study is to use local topical anesthesia to numb the sensory input, captured by branches of the Trigeminal nerve found on the skin in and around the eye, to decrease a hemodynamic reflex seen during placement of a catheter for intra-arterial chemotherapy (IAC) for eye tumors in children. This Trigeminal-cardiac reflex brings about hemodynamic instability during general anesthesia.

Normally, one could block this sensorial input with ophthalmic peribulbar placement of local anesthetics, but these eyes have malignant growth and invasive procedures may cause more harm. The investigators are aiming to numb the sensory branches of the trigeminal nerve non-invasively and observe for any decrease in these events.

Retinoblastoma is a rare tumor of the eye and accounts for 6% of malignancies in children less than 5 years of age. Pediatric anesthesiologists have observed a series of hemodynamic instability following the insertion of a catheter into the cavernous segment of the internal carotid artery or during manipulation of a micro-catheter into the ophthalmic artery for intra-arterial chemotherapy (IAC) of retinoblastoma cases by neuroradiologists. This reaction has been recently published in case reports and observational studies as the treatment of these tumors have moved into the interventional imaging suites. This reaction closely resembles the "diving reflex" seen when a person is submerged in cold water; known as the trigeminal-cardiac reflex. It manifests as a sudden hemodynamic disturbance in arterial blood pressure, heart rate, arrhythmia and changes in pulmonary compliance.Rescue from a trigeminal-cardiac reflex entails increasing intravascular volume, administrating mild to resuscitative doses of epinephrine and ventilatory support.

Catheter manipulation around the ophthalmic artery can stimulate the afferent pathway of the trigeminal nerve, branches V1 and V2, originating around the eye to be treated.The ethmoidal nerve, from the nasal passage on the same side, is also stimulated. This in turn triggers a response by the vagus nerve with hemodynamic instability.

Method: Participants are placed under general endotracheal anesthesia for this scheduled procedure. One drop of ocular antiseptic (betadine 5%) will be placed in the eye to be treated followed by a drop of topical FDA approved local anesthetic, Tetracaine 0.5%, to the nasolacrimal duct ( inner corner of the eye) on the eye to be treated. This will numb the ethmoidal nerve in the nasal passage. This is followed by 1 ml of 3.5% Lidocaine gel to the surface of the eye. This gel is placed on the surface of the eye and skin around the eye to numb V1 and V2 fibers of the trigeminal nerve. The study will observe if there is any decrease in the intensity of the reflex or incidence of the reflex during placement of the micro-catheter.

Topical Anesthesia and Intra-arterial Chemotherapy for Retinoblastoma

Topical Anesthesia to Decrease the Trigeminal-Cardiac Reflex During Intra-arterial Injection of Chemotherapy for Retinoblastoma in Children.

Interventionalist will communicate to the investigator of the catheter placement and our outcome measure will be recorded soon after.

Investigator will communicate when the event is over or rescue drugs given.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Magnesium and Dexmedetomidine in Pheochromocytoma	NCT05102058	Phaeochromocyto... Hemodynamic Ins...	Magnesium-Dexme...	18 Years - 75 Years	Istanbul University
Perioperative Hypotension in Gynaecologic Oncologic Surgery: HPI-ClearSight Versus Arterial Waveform Analysis	NCT05354661	Hypotension Hemodynamic Ins... Gynecologic Can...	Hypotension Pre...	18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy	NCT04607525	Hemodynamic Ins... Supratentorial ...	Dexmedetomidine normal saline	18 Years - 65 Years	Ain Shams University
Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy	NCT04607525	Hemodynamic Ins... Supratentorial ...	Dexmedetomidine normal saline	18 Years - 65 Years	Ain Shams University
Hypotension Prediction With HPI Algorithm During Major Gynecologic Oncologic Surgery	NCT04547491	Intraoperative ... Hemodynamic Ins... Gynecologic Can...	HPI - hypotensi... GDT	18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics	NCT04032600	Malignant Ascit... Ovarian Cancer Hemodynamic Ins...	Paracentesis	18 Years -	Charite University, Berlin, Germany
Magnesium and Dexmedetomidine in Pheochromocytoma	NCT05102058	Phaeochromocyto... Hemodynamic Ins...	Magnesium-Dexme...	18 Years - 75 Years	Istanbul University
Perioperative Hypotension in Gynaecologic Oncologic Surgery: HPI-ClearSight Versus Arterial Waveform Analysis	NCT05354661	Hypotension Hemodynamic Ins... Gynecologic Can...	Hypotension Pre...	18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Topical Anesthesia and Intra-arterial Chemotherapy for Retinoblastoma	NCT02955524	Hemodynamic Ins...	Tetracaine 0.5% Lidocaine hydro...	8 Weeks -	University of Miami

Spots Global Cancer Trial Database for hemodynamic instability