Symptoms and General Pathology

All Conditions

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Digestive System Diseases

Syndrome

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Anesthetics

Propofol

Chrysarobin

Patients undergoing oesophageal- or ventricular resection (n=30)

Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Study of cerebral blood flow

Niels H. Secher, MD, D.M.Sc.

Niels D. Olesen, MD

General anaesthesia often reduces blood pressure whereby blood flow to the brain and other vital organs may become insufficient. Thus, medicine is often administered during anaesthesia to maintain blood pressure. However, it is unclear at what level blood pressure should be aimed at during anaesthesia.

Several factors may affect blood flow to the brain during anaesthesia. During surgery on the internal organs, a hormone may be released that dilates blood vessels and causes a so-called mesenteric traction syndrome characterised by a decrease in blood pressure and flushing. This reaction lasts for approximately thirty minutes and is observed in about half of the patients who undergo surgery on the stomach and intestines. It is unknown whether a mesenteric traction syndrome affects blood flow to the brain. Ventilation is also of importance for blood flow to the brain. Thus, blood flow to the brain is reduced by hyperventilation and increases if breathing is slower. It is unclear whether the relation between blood flow to the brain and ventilation is affected during anaesthesia.

This study will evaluate how blood flow to the brain is affected by anaesthesia and standard treatment of a possible reduction in blood pressure. Further, the study will assess whether blood flow to the brain is affected by development of a mesenteric traction syndrome. Lastly, the project will evaluate blood flow to the brain during short-term changes in the patient's ventilation by adjustments on the ventilator.

Thirty patients planned for major abdominal surgery will be included in the project. The study will take place from the patient's arrival at the operation room and until two hours after the start of surgery. Placement of catheters and anaesthesia are according to standard care. Blood flow to the brain will be evaluated using ultrasound. Oxygenation of the brain, skin and muscle will be evaluated by probes that emit light. Depth of anaesthesia is assessed by recording the electrical activity of the brain. Blood pressure is measured by a catheter placed in an artery at the wrist and blood samples will be drawn from the catheter.

Background General anaesthesia reduces blood pressure, but cerebral autoregulation is considered to maintain its blood flow if mean arterial pressure (MAP) is between 60-150 mmHg. Thus, vasoactive medication is administered to treat anaesthesia-induced hypotension if MAP decreases to below approximately 60 mmHg. In young healthy adults, propofol anaesthesia, with limited reduction in blood pressure, decreases cerebral blood flow by approximately 50% by a decrease in neuronal activity. However, it is unknown whether the anaesthesia-induced reduction in cerebral blood flow is affected by a marked decrease in MAP and whether propofol anaesthesia affects the lower level of cerebral autoregulation.

If central blood volume is maintained, cerebral oxygenation may be unaffected by a decrease in MAP to \~40 mmHg whereas a reduction in central blood volume and cardiac output (CO) during orthostasis or bleeding, reduces cerebral oxygenation when MAP is lower than approximately 80 mmHg. Thus, CO may affect cerebral blood flow and the ability to increase CO is likely of importance for maintaining a sufficient cerebral blood flow.

During anaesthesia, cerebral blood flow and MAP may be affected by various factors including release of vasoactive substances. Manipulation of the abdominal organs may induce a so-called mesenteric traction syndrome (MTS) encompassing a triad of flushing, hypotension, and tachycardia in about half of the patients who undergo major abdominal surgery. MTS typically develops 15-20 min after the start of surgery and the haemodynamic manifestations, that appear to be mediated by prostaglandin I2, last for approximately 30 min. The effect of MTS on cerebral blood flow is unknown. Prostaglandin I2 dilates cerebral arteries in vitro but does not affect cerebral blood flow when administered to healthy subjects. In a previous study we found that MTS increases near-infrared spectroscopy determined frontal lobe oxygenation possibly due to an increase in extracranial circulation while there was no effect on middle cerebral artery mean flow velocity as an index of changes in cerebral blood flow.

Propofol anaesthesia appears not to affect the CO2 reactivity of the middle cerebral artery as determined by transcranial Doppler ultrasonography, but the CO2 reactivity of the internal carotid artery during propofol anaesthesia is unknown.

Objective The purpose of this study is to evaluate how internal carotid artery blood flow is affected by propofol anaesthesia and related hypotension, and by administration of phenylephrine as standard care to treat anaesthesia-induced hypotension. Further, the study will assess whether internal carotid artery blood flow is affected by development of MTS and whether propofol anaesthesia affects the CO2 reactivity of the internal carotid artery.

Hypotheses

1. Propofol anaesthesia and related anaesthesia-induced hypotension (MAP \< 65 mmHg) reduces internal carotid artery blood flow
2. Treatment of anaesthesia-induced hypotension by administration of phenylephrine increases internal carotid artery blood flow
3. Development of MTS increases near-infrared spectroscopy determined frontal lobe oxygenation due to an increase in forehead skin blood flow and oxygenation with no effect on internal carotid artery blood flow
4. Propofol anaesthesia lowers the CO2 reactivity of the internal carotid artery

Methods The study will include thirty patients undergoing oesophageal- or ventricular resection. The study lasts from when the patient arrives to the operating room and until two hours after the start of surgery. As part of standard care all patients will be instrumented with arterial and central venous catheters. Anaesthesia will be induced by propofol and maintained by propofol and remifentanil combined with epidural anaesthesia. Development of MTS is defined by flushing within the first 60 min of surgery. Measurements include unilateral internal carotid artery blood flow evaluated by duplex ultrasound, MAP and heart rate as recorded by a transducer connected to the arterial line, central haemodynamics (stroke volume, CO, and total peripheral resistance) evaluated by pulse contour analysis of the arterial pressure curve, frontal lobe and muscle oxygenation as determined by near-infrared spectroscopy, forehead skin blood flow, haemoglobin concentrations, and oxygenation assessed by laser Doppler flowmetry, and depth of anaesthesia determined by Bispectral Index. At each time point 2 measurements of internal carotid artery blood flow are collected and the mean is taken. Arterial blood will be drawn for analysis of the arterial CO2 tension (PaCO2).

During the study PaCO2 will be maintained at the value before induction of anaesthesia by ventilator adjustments. Internal carotid artery CO2 reactivity before induction of anaesthesia will be determined by evaluations of blood flow and PaCO2 during normoventilation and during hyperventilation to reduce PaCO2 by 1.5 kPa as guided by end-tidal CO2 tension (PetCO2) and measurements will be conducted when PetCO2 has been stable for 5 min. The CO2 reactivity during anaesthesia will be determined by evaluations of internal carotid artery blood flow and PaCO2 at a PaCO2 at the value before induction of anaesthesia and 1.5 kPa above and below that value as guided by PetCO2 and measurements will be conducted when PetCO2 has been stable for 5 min. The CO2 reactivity before and during anaesthesia is calculated as the percentage change in internal carotid artery blood flow per kPa change in PaCO2. Analysis of internal carotid blood flow will be after correction for CO2 reactivity.

Blood samples for analysis of markers of MTS (6-keto-prostaglandin-F1, pro-ANP, ACTH, cortisone, IL-1, IL-6, and TNF-α) will be drawn before induction of anaesthesia and 20 and 60 min after the start of surgery. Total amount of blood samples will be no more than 75 ml. Patients will be excluded if the planned surgery is cancelled and excluded patients will be replaced.

Measurements will be conducted and arterial blood drawn at the following time points:

* Before induction of anaesthesia during normoventilation and hyperventilation
* After induction of anaesthesia
* During anaesthesia-induced hypotension (MAP \< 65 mmHg)
* After treatment of anaesthesia-induced hypotension by administration of phenylephrine
* 5 min before and after incision and 0, 20, 40 and 70 min after development of MTS and 20, 40, 60 and 90 min after the start of surgery in patients who did not develop MTS
* During normo-, hyper-, and hypocapnia during anaesthesia in random order

Statistics Trial size: The minimal clinically important difference in internal carotid artery blood flow by treatment of anaesthesia-induced hypotension is considered to be 10%, corresponding to approximately 24 ml/min, and twenty-seven patients were considered required assuming a 42 ml/min SD with a 5% significance level and a power of 80%.

Cerebral Blood Flow During Propofol Anaesthesia

Unilateral internal carotid artery blood flow \[ml/min\] assessed by duplex ultrasound.

Association by multiple regression between changes in unilateral internal carotid artery blood flow \[ml/min\] as outcome variable and changes in mean arterial pressure \[mmHg\] and cardiac output \[l/min\] as covariates.

Internal carotid artery blood flow \[ml/min\] was assessed by duplex ultrasound. Mean arterial pressure \[mmHg\] was recorded by a transducer connected to an arterial line. Cardiac output \[l/min\] was evaluated by pulse contour analysis (Modelflow) that estimates cardiac output by analysis of the arterial pressure curve taking age, gender, height and weigth into account.

Near-infrared spectroscopy determined frontal lobe oxygenation \[%\] as compared between those patients who develop a MTS (defined as flushing within 60 min after the start of surgery) and those who do not. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.

Forehead skin blood flow \[PU\] assessed by laser Doppler flowmetry as compared between those patients who develop mesenteric traction syndrome (defined as flushing within 60 min after the start of surgery) and those who do not. Laser Doppler flowmetry applies a laser placed on the forehead that penetrates the skin and is scattered with a Doppler shift by the red blood cells and return to a detector that evaluates the amount of backscattered light and Doppler shift. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.

Forehead skin oxygenation \[%\] assessed by laser Doppler flowmetry as compared between those patients who develop a MTS (defined as flushing within 60 min after the start of surgery) and those who do not. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.

Unilateral internal carotid artery blood flow \[ml/min\] assessed by duplex ultrasound as compared between those patients who develop a MTS (defined as flushing within 60 min after the start of surgery) and those who do not. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.

Unilateral internal carotid artery blood flow \[ml/min\] assessed by duplex ultrasound and arterial CO2 tension (PaCO2) \[kPa\] was evaluated by gas analysis. Changes in PaCO2 are guided by evaluation of end-tidal CO2 tension.

The CO2 reactivity to hypocapnia when awake and during anaesthesia is calculated as the percentage change in internal carotid artery blood flow per kPa change in PaCO2. The CO2 reactivity when awake and when anaesthetized is compared.

Heart rate \[bpm\] as recorded continuously by a transducer connected to an arterial line.

Mean arterial pressure \[mmHg\] as recorded continuously by a transducer connected to an arterial line.

Cardiac output \[l/min\] as evaluated continuously by pulse contour analysis of the arterial pressure curve (Modelflow).

Stroke volume \[ml\] as evaluated continuously by pulse contour analysis of the arterial pressure curve (Modelflow).

Rigshospitalet, Denmark

Patients undergoing oesophageal- or ventricular resection (n=30)

Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.

Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Study of Cerebral Blood Flow

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Denmark

Region of Enrollment

Internal carotid artery blood flow during anesthesia-induced hypotension

Niels D. Olesen

Changes in Internal Carotid Artery Blood Flow by Treatment of Anaesthesia-induced Hypotension

Changes in Internal Carotid Artery Blood Flow by Induction of Anaesthesia.

Association by Multiple Regression Between Changes in Internal Carotid Artery Blood Flow, Mean Arterial Pressure and Cardiac Output by Treatment of Anaesthesia-induced Hypotension.

Changes in Frontal Lobe Oxygenation by Development of Mesenteric Traction Syndrome (MTS).

Changes in Forehead Skin Blood Flow by Development of Mesenteric Traction Syndrome (MTS).

Changes in Forehead Skin Oxygenation by Development of Mesenteric Traction Syndrome (MTS).

Changes in Internal Carotid Artery Blood Flow by Development of Mesenteric Traction Syndrome (MTS).

Comparison of reactivity to hypocapnia when awake and during anaesthesia was evaluated by a linear mixed model with the relative change in ICA flow as outcome and fixed effects were the change in PaCO2 and an interaction factor for the difference between awake and anaesthesia. The reported result is the interaction factor.

Changes in the CO2 Reactivity of the Internal Carotid Artery From Before to After Induction of Anaesthesia.

Changes in Heart Rate From Baseline Before Induction of Anaesthesia.

Changes in Mean Arterial Pressure From Baseline Before Induction of Anaesthesia.

Changes in Cardiac Output From Baseline Before Induction of Anaesthesia.

Changes in Stroke Volume From Baseline Before Induction of Anaesthesia.

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Carcinoma

Prostatic Neoplasms

Erectile Dysfunction

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.

Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive sham LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.

Undergo nerve-sparing prostatectomy per standard of care

Nerve-Sparing Prostatectomy

Medical Device Usage and Evaluation

Duplex Ultrasound

Survey Administration

Sham Intervention

Paul Chung, MD

This phase I clinical trial studies how well low intensity shockwave therapy (LiSWT) improves erectile function in patients who have had nerve-sparing radical prostatectomy (NS-RP), a type of surgery that attempts to save the nerves near the tissues being removed, for prostate cancer. Erectile dysfunction (ED) is a known side effect of the radical prostatectomy procedure. The low intensity shockwave therapy delivers painless electrotherapy pulse to increase blood flow and supply, activation of tissues and wound healing. Using LiSWT after NS-PRP may improve erectile function in men with prostate cancer.

PRIMARY OBJECTIVE:

I. To determine whether LiSWT following nerve-sparing radical prostatectomy (NS-RP) improves outcomes in men with erectile dysfunction (ED) supported by cGMP phosphodiesterase inhibitor (PDE5i) medication.

SECONDARY OBJECTIVES:

I. To determine whether LiSWT improves duplex doppler ultrasound (DDUS) flow parameters at 6 months following LiSWT treatment.

II. To determine the postoperative durability of any beneficial outcome of LiWST treatment to erectile function.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.

ARM II: Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive sham LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.

Low-Intensity Shockwave Therapy to Treat Erectile Dysfunction and Preserve Erectile Function After Prostate Cancer Surgery

Preservation of Erectile Function With Early Postoperative Application of Low Intensity Shockwave Therapy After Nerve Sparing Radical Prostatectomy

Will be assessed using the International Index of Erectile Function (IIEF) The IIEF is a15-item questionnaire - each item scored from 0 to 5 - examines five main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction. Outcomes measured only at 6 months post randomization will be analyzed using analysis of covariance with adjustment for the baseline value.

Will be assessed using the Erection Hardness Scale (EHS). The EHS is a single-item validated Likert scale. Mixed effect linear regression will be used to model post randomization repeated measurements of continuous outcomes. From the results of the model, will estimate the mean difference between groups at each time point along with a 95% confidence interval. Outcomes measured only at 6 months post randomization will be analyzed using analysis of covariance with adjustment for the baseline value.

Will be assessed by penile flow parameters. Mixed effect linear regression will be used to model post randomization repeated measurements of continuous outcomes. From the results of the model, will estimate the mean difference between groups at each time point along with a 95% confidence interval. Outcomes measured only at 6 months post randomization will be analyzed using analysis of covariance with adjustment for the baseline value.

Will be assessed using the IIEF, EHS, Sexual Encounter Profile diary and the Patient Global Impression of Improvement survey scores. Mixed effect linear regression will be used to model post randomization repeated measurements of continuous outcomes. From the results of the model, will estimate the mean difference between groups at each time point along with a 95% confidence interval.

Thomas Jefferson University

Heart and Blood Diseases

Thrombosis

Venous Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

There is only one cohort in this study. They all received the same follow up and ultrasound protocol.

Duplex Ultrasound was performed for every participants for the diagnosis of symptomatic or asymptomatic deep vein thrombosis

Orhan Alimoglu, Prof

Major abdominal surgery for cancer is major risk factor for thromboembolism. Patients who undergo major abdominal surgery are prone to develop venous thromboembolism, both in the early postoperative period and after hospital discharger. There are strong recommendations in the international guidelines in favor to pharmacological thromboprophylaxis. Thus there is no consensus dor the duration of the prophylaxis. There are authors that suggest extended prophylaxis up to 4 week after surgery. On the other hand, there are prospective randomized trials that inpatient (short-term up to 7-10 days) prophylaxis is adequate.

This is a retrospective cohort study with 89 patients who underwent major abdominal surgery for colorectal and gastric cancer. All patients received short term prophylaxis (during hospital stay only) rather than extended prophylaxis (4 weeks). All participants received duplex ultrasound in the study period for the diagnosis of deep vein thrombosis.

Short-term Perioperative Thromboprophylaxis After Major Abdominal Surgery

Outcomes of Short-term Perioperative Thromboprophylaxis After Gastrointestinal Cancer Surgery

All patients in the cohort received short time prophylaxis for deep vein thrombosis instead of prolonged duration. All patients will be assessed with ultrasound.

The patients with deep vein thrombosis in the cohort will be assessed according to their postoperative period features, histories, chemo treatments etc. with and questionnaire.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cerebral Blood Flow During Propofol Anaesthesia	NCT02951273	Gastrointestina...	Study of cerebr...	18 Years -	Rigshospitalet, Denmark
Low-Intensity Shockwave Therapy to Treat Erectile Dysfunction and Preserve Erectile Function After Prostate Cancer Surgery	NCT05877144	Erectile Dysfun... Localized Prost... Stage I Prostat... Stage II Prosta... Stage III Prost...	Nerve-Sparing P... Medical Device ... Duplex Ultrasou... Survey Administ... Nerve-Sparing P... Sham Interventi... Duplex Ultrasou... Survey Administ...	18 Years - 80 Years	Thomas Jefferson University
Low-Intensity Shockwave Therapy to Treat Erectile Dysfunction and Preserve Erectile Function After Prostate Cancer Surgery	NCT05877144	Erectile Dysfun... Localized Prost... Stage I Prostat... Stage II Prosta... Stage III Prost...	Nerve-Sparing P... Medical Device ... Duplex Ultrasou... Survey Administ... Nerve-Sparing P... Sham Interventi... Duplex Ultrasou... Survey Administ...	18 Years - 80 Years	Thomas Jefferson University
Short-term Perioperative Thromboprophylaxis After Major Abdominal Surgery	NCT04709510	Deep Vein Throm...	Duplex Ultrasou...	18 Years -	Istanbul Medeniyet University

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