Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

The LLETZ procedure will be performed under local anaesthesia

The LLETZ procedure will be performed under general anaesthesia

Conization will be performed under local anaesthesia

LLETZ under local anaesthesia

Conization will be performed under general anaesthesia

LLETZ under general anaesthesia

Ziad Hilal, M.D.

The investigators conduct a prospective, randomized trial to assess the benefits of performing large loop excision of the transformatione zone (LLETZ) under local anesthesia and compare it to LLETZ under general anesthesia. The primary endpoint of this study is women´s satisfaction.

LLETZ Under General Versus Local Anesthesia

Large Loop Excision of the Transformatione Zone Under General Versus Local Anesthesia: a Randomized Trial.

Patients will score their satisfaction by using a 11-step visual analogue scale (VAS) ranging from '0' ("not satisfied at all") to '10' ("very satisfied") 2 hours after Treatment

patients will score their postoperative pain Level using a 11-step visual analogue scale (VAS) ranging from '0' ("no pain" ) to '10' ("maximum pain") within 2 hours after surgery

the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room

the time from the beginning of the Operation (start of the electrosurgical method) until the end of the operation (the end of hemostatic interventions) will be measured in minutes

Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively

the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds

Surgeons will score their satisfaction by using a 11-step visual analogue scale (VAS) 20 minutes after Treatment

surgeons will count the number of the surgical specimen (1 vs. \>1)

The circumference, length and thickness of The surgical specimens will be measured

intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively

Resection margin is judge as "R0" if abnormal cells are not found in the margin of the biopsy or "R1" if abnormal cells remain in the margin of the biopsy. The histopathological examination will be done by an Independent pathologist

Zydolab - Institute of Cytology and Immune Cytochemistry

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Nervous System Diseases

Pain, Postoperative

Breast Neoplasms

Carcinoma

Pain

Carcinoma in Situ

Breast Carcinoma In Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Postoperative Complications

Neurologic Manifestations

Breast Diseases

Skin Diseases

Surgery carried out according to clinical routine under general anaesthesia.

Surgery carried out under local tumescent anaesthesia. Procedure

Breast surgery is carried out under general anesthesia.

General Anaesthesia

Breast surgery is carried out under local tumescent anesthesia.

Local tumescent anaesthesia

Bettina Böer, Dr.

The present study aims to investigate the impact of Tumescent Local Anesthesia (TLA) on pain perception following surgeries typical for breast cancer. Previous research has already confirmed the feasibility of conducting operations in TLA for benign breast conditions. In contrast to general anesthesia, Tumescent Local Anesthesia involves local anesthesia of the surgical site, allowing patients to remain awake during the procedure and eliminating the risks associated with general anesthesia. Additionally, if needed, sedatives or further anesthesia can be administered through the vein. Building upon the successful applications of TLA in benign breast surgeries, this follow-up study at the Department of Women's Health focuses on enhancing surgical techniques, pain management, and postoperative care for breast cancer-related procedures. Simultaneously, our goal is to gather scientific data regarding the application of this technique. This research contributes to the continuous advancement of medical practices in the field of breast surgery.

Postoperative Pain After Breast Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia ( TLA-001 )

Prospective Unicentre Non-randomised Study: Comparison of Postoperative Pain After Breast Cancer-typical Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia - TLA 001

The primary endpoint is the recording of postoperative pain. Pain will be measured on 1.-3. postoperative day using the Visual Analogue Scale (VAS). The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

Additionally, the postoperative pain will be assessed using the VAS at the post-operative follow-up consultation, which usually takes place 2-5 weeks after surgery.

The outcome measure for Health-Related Quality of Life (HRQoL) in this study utilizes the Breast-Q questionnaire specific to breast cancer (BCT/Mastectomy). Preoperative assessments are conducted during the recruitment phase following participants' consent, providing baseline HRQoL data. Postoperative evaluations occur 2-5 weeks after the surgery during follow-up discussions, capturing changes in HRQoL in the immediate aftermath of the mastectomy and informing the study about the impact of the surgical intervention on participants' quality of life.

The outcome measure for postoperative pain medication requirements includes the assessment of administered pain medications, encompassing anti-inflammatory drugs, opioids, and non-opioid analgesics.

Patient's medical records will be examined to identify the pain medications administered postoperatively. The administered pain medications will then be categorized into anti-inflammatory drugs, opioids, and non-opioid analgesics. The total dosage of each type of pain medication administered will be calculated until hospital dischanrge. To evaluate the effectiveness of the administered pain medications in managing postoperative pain, pain assessment tool (Visual Analog Scale) will be used to measure pain intensity (2-3x daily for exercise and rest). On the first postoperative day, patients also receive the standardized QUIPS pain questionnaire consisting of 16 questions pain assesement after operation.

Complications in the study will be recorded during the hospital stay and post-operative follow-up, using the Clavien- Dindo classification system to categorize and assess their severity, contributing vital insights into the safety and efficacy of the surgical intervention.

The "length of hospital stay" refers to the time elapsed from a patient's admission to their discharge.

In the current clinical study, the duration of surgery, measured as the time from incision to wound closure, will be meticulously recorded using precise timekeeping instruments. This involves capturing the elapsed time from the moment the surgical incision is made to the point when the wound is closed.

The drainage delivery rate will be assessed by measuring the volume of fluid collected by the drainage system until the point of discharge. This involves tracking the total volume in milliliters (ml) accumulated over the entire duration of drainage until the patient is discharged.

An additional outcome criterion is whether there is a R1 situation with subsequent surgery, answered yes/no.

The secondary outcome criterion, "preoperative fear of surgery and anesthesia," will be assessed using the APAIS (Amsterdam Preoperative Anxiety and Information Scale) questionnaire and a Visual Analog Scale (VAS) ranging from 0 to 10. The APAIS questionnaire consists of multiple items measuring anxiety and information desire related to surgery and anesthesia, with higher scores indicating greater preoperative fear. The Visual Analog Scale, ranging from 0 (no fear) to 10 (extreme fear), allows participants to subjectively rate their apprehension, providing a numerical representation of the intensity of preoperative fear.

The costs of breast surgery conducted under general anesthesia versus local anesthesia serve as a crucial outcome criterion in the clinical study. This assessment involves comparing the overall expenses associated with each anesthesia method, including anesthesia administration, recovery, and potential complications, to determine the economic implications and cost-effectiveness of the two approaches in the context of breast surgery.

The satisfaction of the surgeon with the course of the operation will be measured on a scale of 0 to 10, where 0 represents not satisfied at all and 10 signifies extreme satisfaction.

University Hospital Tuebingen

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Anti-Arrhythmia Agents

Channel Blockers

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Adjuvants, Anesthesia

Analgesics

Psychotropic Drugs

Lidocaine

Dexamethasone

Fentanyl

Midazolam

Propofol

Levobupivacaine

Dexamethasone acetate

Remifentanil

Omeprazole

Metoclopramide

Tramadol

Vecuronium Bromide

Patients undergoing open retropubic radical prostatectomy under general anaesthesia

Patients undergoing open retropubic radical prostatectomy under combined (epidural and spinal) anaesthesia

All patients in the general anaesthesia group will be premedicated with intravenously administered (iv) midazolam (2mg) and fentanyl (100 mcg). Induction will be performed using intravenous propofol (2.5-3mg/kg) and lidocaine (40mg); dexamethasone 8mg, metoclopramide 10mg and omeprazole 40mg will also be administered. After successful tracheal intubation, total intravenous anaesthesia will be maintained by administering propofol (0.05 mg/kg/sec iv) and remifentanil (0.2 mcg/kg/sec iv). Pain management will be achieved by paracetamol (1g iv) and tramadol (100mg iv) whereas muscle relaxation by vecuronium (0.6 mg/kg iv).

Combined (epidural and spinal) anaesthesia will be performed using an epidural 18G needle and a spinal 27G needle, in the L2-L3 or L3-L4 interspace. Induction will be carried out by spinal intrathecal administration of levobupivacaine (2.6-3ml of 0.5%) and mild sedation by midazolam (5mg iv in bolus). All patients will be administered dexamethasone 8mg, metoclopramide 10mg and omeprazole 40mg iv. Maintenance will be performed 75 minutes after induction and obtained using an epidural administration of levobupivacaine (4-5ml of 0.5%).

Combined (Epidural and Spinal) Anaesthesia

All patients will undergo a nerve-sparing open retropubic radical prostatectomy

Open Retropubic Radical Prostatectomy

Konstantinos Pikramenos, MD

Iraklis Mitsogiannis, Assoc. Prof.

Ioannis Varkarakis, Prof.

Athanasios Papatsoris, Prof.

Prostate cancer is one of the most commonly diagnosed neoplasm in men worldwide. The gold standard of therapy is radical prostatectomy, a wide surgical excision of the neoplasm and can be performed either open, laparoscopic or robotic. The open retropubic approach, still performed today, can be completed under either general anaesthesia or combined (spinal/epidural) anaesthesia without any clear guideline on which one should be preferred.

In this study the investigators aim to evaluate general anaesthesia and combined (spinal/ epidural) anaesthesia in patients undergoing open retropubic radical prostatectomy and define whether these may have an impact on the oncological outcome and safety of the procedure.

The Effects of Method of Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy

Comparative Study of the Effects of Combined Spinal Anaesthesia and General Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy in Patients With Localised Prostate Cancer

Available from the corresponding author on reasonable request.

Measurement of patients systolic and diastolic blood pressure during the operation and post-operatively for 72 hours.

Measurement of patients Heart Rate during the operation and post-operatively for 72 hours.

Calculation of the Surgical APGAR score for each patient during surgery. The lower the score, on a scale of 1-10, the worst the prognosis of the patient.

SAS is calculated using three variables:

* Estimated blood loss (on a 0-3 scale, 0 points \>1000 ml, 1 point 601-1000ml, 2 points 101-600 ml, 3 points \<100ml)
* Lowest mean arterial pressure (on a 0-3 scale, 0 points \<40 mmHg, 1 point 40-54 mmHg, 2 points 55-69 mmHg, 3 points \>70 mmHg)
* Lowest heart rate (on a 0-4 scale, 0 points \>85 bpm, 1 points 76-85 bpm, 2 points 66-75 bmp, 3 points 56-65 bmp, 4 points \<55 bmp) during surgery.

Measured from suction contents intra-operatively in ml

Haemoglobin measurement before the operation and at 12-, 24- and 48-hours post-operatively, in g/dL

Time required for:

* Induction of anaesthesia
* Completion of the operation
* Post-operative time until the patient is successfully transferred to the recovery room

Measured using a pain Visual Analogue Scale (VAS) at 6-, 24- and 48-hours after the operation.

VAS is a self-reporting pain scale based on a 0 to 10-point system, with each point measuring 10mm on a linear line. Every patient was asked to indicate his pain levels from "No Pain" (equals 0) to "Worst Pain Imaginable" (equals 10).

Complications related to the procedure:

* Intraoperative bleeding
* Post-operative bleeding
* Bowel perforation
* Cardiovascular
* Respiratory

Complications related to the anaesthesia technique performed:

* Post-operative headache
* Nausea and vomiting
* Any signs of potential nerve damage (manifested as inability to gain leg motility)

Measurement of Prostatic Specific Antigen (PSA) levels at 6 to establish a PSA nadir value

Measurement of Prostatic Specific Antigen (PSA) levels at 12 post-operation to detect any biochemical recurrence

Measured using the International Index of Erectile Function (IIEF-5) questionnaires pre-operatively and at 3-, 6- and 12-months post-surgery.

The test is composed of 5 questions with 5 points for each question. Patients are evaluated accordingly:

* Score 22 or more = No Erectile Disfunction
* Score 17-21 = Mild Erectile Disfunction
* Score 12-16 = Mild to moderate Erectile Disfunction
* Score 8-11 = Moderate Erectile Disfunction
* Score 7 or less = Severe Erectile Disfunction

Results will be:

* Analysed and compared to evaluate any potential difference of the two methods of anaesthesia, on post-operational erectile function
* Analysed comparing pre-operation with post-operation questioners overall, to evaluate erectile disfunction after radical prostatectomy regardless of method of anaesthesia.

Measured using the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form at 12 months post-surgery.

The Questionnaire is consisted of 4 questions:

* Frequency "How often do you leak urine?" on a scale of 0 (never) to 5 (all the time)
* Amount of leakage "How much urine do you leak?" on a scale to 0 (none) to 3 (a large amount)
* Overall impact on quality of life "How much does it interfere with your life?" on a scale of 0 (not at all) to 10 (a great deal)
* Timing of leakage "When does urine leak?"

Days until patient discharge from the hospital.

Satisfaction, using the Short Assessment of Patient Satisfaction (SAPS) Questionnaire, is measured in a scale of 0 to 28, with 0 to 10 equals to "Very Dissatisfied", 11-18 equals to "Dissatisfied", 19-26 equals to "Satisfied" and 27-28 equals to "Very Satisfied"

National and Kapodistrian University of Athens

Sismanoglio General Hospital

Principal Investigator, Urology Resident, MD

Digestive System Diseases

Syndrome

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Antirheumatic Agents

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

Rocuronium

Neuromuscular Nondepolarizing Agents

Neuromuscular Blocking Agents

Rocuronium bolus was administered, according to our protocol, to facilitate surgery and ventilation.

Aim of this trial is to define if Trend of Four (TOF) values after a bolus of rocuronium is correlated with Bispectral Index BIS values during standard general anaesthesia for breast surgery.

Rocuronium. a curarizing agent, has been shown to decrease Bispectral Index (BIS) in awake volunteers.

However, correlation between Trend of Four (TOF) values after a bolus of rocuronium and BIS values during general anaesthesia for breast surgery has not been defined yet.

Investigators want to analyze this correlation during general anaesthesia conducted using Propofol and remifentanil. All of these drugs will be delivered with Targeted-Controlled Infusion pumps (in particular Eleveld for Propofol, Minto for Remifentanil), commonly used to deliver general anaesthesia. At stable anaesthesia maintenance, if requested for surgical (ie more muscle relaxation) or anesthesiological reasons (i.e. avoid air insufflation) a standard Rocuronium bolus (0.6 mg/kg) was given. In these case, with rocuronium bolus justified by clinical reasons, authors will observationally record the BIS values and the TOF values.

Effect of Rocuronium on BIS Values

Correlation Between Trend of Four Values and Bispectral Index Values During General Anaesthesia for Breast Surgery.

Discover if there is linear correlation between TOF values (utilized for curarization monitoring) and BIS values (utilized for deep of hypnosis monitoring) during standard general anaesthesia conducted with Propofol and remifentanil with targeted controlled infusion pumps, usually adopted in our Hospital to delivery general anaesthesia

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
LLETZ Under General Versus Local Anesthesia	NCT03494686	Uterine Cervica...	LLETZ under loc... LLETZ under gen...	18 Years -	Zydolab - Institute of Cytology and Immune Cytochemistry
Postoperative Pain After Breast Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia ( TLA-001 )	NCT06335108	Breast Carcinom... Breast Carcinom...	General Anaesth... Local tumescent...	18 Years -	University Hospital Tuebingen
The Effects of Method of Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy	NCT05566405	Prostatic Neopl...	General Anaesth... Combined (Epidu... Open Retropubic...	-	Sismanoglio General Hospital
Cerebral Blood Flow During Propofol Anaesthesia	NCT02951273	Gastrointestina...	Study of cerebr...	18 Years -	Rigshospitalet, Denmark
Effect of Rocuronium on BIS Values	NCT05681611	Breast Cancer General Anaesth...	Rocuronium	18 Years - 80 Years	University of Padova
Postoperative Pain After Breast Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia ( TLA-001 )	NCT06335108	Breast Carcinom... Breast Carcinom...	General Anaesth... Local tumescent...	18 Years -	University Hospital Tuebingen
LLETZ Under General Versus Local Anesthesia	NCT03494686	Uterine Cervica...	LLETZ under loc... LLETZ under gen...	18 Years -	Zydolab - Institute of Cytology and Immune Cytochemistry
The Effects of Method of Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy	NCT05566405	Prostatic Neopl...	General Anaesth... Combined (Epidu... Open Retropubic...	-	Sismanoglio General Hospital

Spots Global Cancer Trial Database for general anaesthesia