Neoplasms

Nervous System Diseases

All Conditions

Brain Neoplasms

Positive end-expiratory pressure will be set at 5 cmH2O during controlled mechanical ventilation.

Positive end-expiratory pressure will be set at 10 cmH2O during controlled mechanical ventilation.

5 cmH2O Positive end-expiratory pressure (PEEP)

10 cmH2O Positive end-expiratory pressure (PEEP)

Halide H Şahinkaya, MD

Çağlar Ayar, MD

Alper Tabanlı, MD

Zeki T Tekgül, MD

The goal of this prospective single-blind randomized clinical trial is to compare the effect of two different positive end expiratory pressure (PEEP) levels on regional cerebral oxygen saturation in patients scheduled for craniotomy due to supratentorial masses.

The main question it aims to answer is that how high PEEP level effects the regional cerebral oxygen saturation in patients with high intracranial pressure due to mass effect. Patients will be divided into two groups as Group low PEEP (5 cmH2O) and Group high PEEP (10 cmH2O). Researchers will compare the changes of regional cerebral oxygen saturations between two groups by near infra-red spectroscopy.

In this prospective single-blind study, American Society of Anesthesiologists physical status classification system (ASA) I and II patients aged older than 18 years undergoing craniotomy will be enrolled for the study. Patients will be divided into two groups with computer-based randomization technique. Written and verbal approval will be taken from all patients. Premedication will not be used. Patients will be monitorized by standard non-invasive monitorization (electrocardiography, non-invasive blood pressure measurement, peripheral oxygen saturation) in the operating room. Cerebral/somatic oximeter, near infra-red spectroscopy (NIRS) sensor will be placed on the frontotemporal area and regional cerebral oxygen saturation will be monitorized continuously. Remifentanil infusion with a dose of 0.25 mcg/kg/min will be started two minutes before the induction. After preoxygenation with 6 L/min oxygen for 5 minutes, general anesthesia induction for patients in both groups will be held with intravenous 2 mg/kg propofol. Rocuronium bromide (0.6 mg/kg) will be used for muscle relaxation. Endotracheal intubation will be performed. Controlled mechanical ventilation will be used during the surgery. Invasive arterial blood pressure monitorization will be done and a central venous catheter will be placed in both groups.

In group low PEEP, the patients' settings of mechanical ventilation will be as tidal volume 6-8 mL/kg, inspired oxygen fraction (FiO2) 0.4, PEEP 5 cmH2O. Frequency will be set according to the end tidal carbon dioxide pressure (ETCO2) where it will be 30-32 mmHg.

In group high PEEP, the patients' settings of mechanical ventilation will be as tidal volume 6-8 mL/kg, inspired oxygen fraction (FiO2) 0.4, PEEP 10 cmH2O. Frequency will be set according to the end tidal carbon dioxide pressure (ETCO2) where it will be 30-32 mmHg.

Remifentanil with a dose of 0.05-2 mcg kg/min and propofol with a dose of 50-200 mcg/kg/min will be infused for general anesthesia maintenance in both groups. Dose of remifentanil infusion will be changed according to the blood pressure. If the mean arterial blood pressure and/or heart rate will decrease to 20% of the baseline mean arterial blood pressure and heart rate, the infusion dose will be lowered. If this decrease in heart rate will be over 25%, intravenous 0.5 mg atropin will be administered. If the mean arterial blood pressure will be under 55 mmHg, intravenous 5 mg ephedrine will be administered. If the mean arterial blood pressure will continue to decrease, PEEP will be lowered. If the peripheral oxygen saturation will be under 92%, the inspired oxygen fraction or PEEP will be increased. In these conditions, the patient will be out of study.

1 gr paracetamol will be given intravenously for pain relief. Sugammadex will be used with a dose of 4 mg/kg for extubation.

Regional cerebral oxygen saturation measures will be recorded nine (9) times during the study; pre-induction (period 1), post-induction (period 2), skull pinning (period 3), before dura opening (period 4), after dura opening (period 5), surgical resection of the mass (period 6), dura closure (period 7), end of the surgery (period 8) and end of anesthesia (period 9).

Effect of Different Positive End Expiratory Pressures on Regional Cerebral Oxygen Saturation

Evaluation of the Effect of Different PEEP Levels on Regional Cerebral Oxygen Saturation in Patients Undergoing Elective Craniotomy for Excision of Brain Tumors ; Randomized Controlled Clinical Trial

The measurement of regional cerebral oxygen saturation before anesthesia induction

The measurement of regional cerebral oxygen saturation after anesthesia induction

The measurement of regional cerebral oxygen saturation during skull pinning

The measurement of regional cerebral oxygen saturation before dura opening

The measurement of regional cerebral oxygen saturation after dura opening

The measurement of regional cerebral oxygen saturation during surgical resection of the mass

The measurement of regional cerebral oxygen saturation after dura closure

The measurement of regional cerebral oxygen saturation at the end of surgery

The measurement of regional cerebral oxygen saturation at the end of anesthesia

Bozyaka Training and Research Hospital

MD, Anesthesiology Specialist, Clinical Director

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Breast Neoplasms

Ganglion Cysts

Sleep Deprivation

Synovial Cyst

Cysts

Mucinoses

Connective Tissue Diseases

Dyssomnias

Sleep Wake Disorders

Neurologic Manifestations

Mental Disorders

Psychotic Disorders

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Ropivacaine

Anesthetics, Local

All patients undergoing breast cancer operation will be the treatment intervention with general anesthesia as an adjunct to stellate-ganglion block with saline.

All patients undergoing breast cancer operation will be the treatment intervention with general anesthesia as an adjunct to stellate-ganglion block with 0.25% ropivacaine hydrochloride.

stellate-ganglion block with 0.25% ropivacaine hydrochloride

0.25% ropivacaine hydrochloride

saline

Wen-fei Tan, PhD,MD

Stellate-ganglion block have been done safely for more than 60 years. It has proved to provide survivors of breast cancer with relief from hot flushes and sleep dysfunction with few or no side-effects. The aim of the present study is to evaluate postoperative sleep quality of patients undergoing breast cancer surgery with Stellate-ganglion block performed in the operation.

This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to Stellate-ganglion block with 0.25% ropivacaine hydrochloride or saline. The objective of the trial is to evaluate the postoperative sleep quality of patients undergoing breast cancer operation with Stellate-ganglion block 0.25% ropivacaine hydrochloride or saline.

Sleep Quality After Stellate-ganglion Block of Patients Undergoing Breast Cancer Operation

The primary objective is to compare postoperative sleep quality, as measured using a bispectral index-Vista monitor during the first night after surgery.

physiological parameter of regional cerebral oxygen saturation of all patients during the operation will be recorded.Regional cerebral oxygen saturation measured by near-infrared spectroscopy in the frontal lobe has been used previously to evaluate overall cerebral blood flow. The normal range of cerebral oxygen saturation is 55-80%.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Different Positive End Expiratory Pressures on Regional Cerebral Oxygen Saturation	NCT05961917	Regional Cerebr...	5 cmH2O Positiv... 10 cmH2O Positi...	18 Years -	Bozyaka Training and Research Hospital
Sleep Quality After Stellate-ganglion Block of Patients Undergoing Breast Cancer Operation	NCT02651519	Sleep Deprivati...	0.25% ropivacai... saline	18 Years - 55 Years	China Medical University, China
Effect of Different Positive End Expiratory Pressures on Regional Cerebral Oxygen Saturation	NCT05961917	Regional Cerebr...	5 cmH2O Positiv... 10 cmH2O Positi...	18 Years -	Bozyaka Training and Research Hospital

Spots Global Cancer Trial Database for regional cerebral oxygen saturation