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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Older than 18 years.
  • - American Society of Anesthesiologists physical status classification system (ASA) I and II.
  • - Patients scheduled for elective craniotomy.
  • - Patients with supratentorial mass.

Exclusion Criteria:

  • - Hemoglobin concentration lower than 9 mg/dL.
  • - Uncontrolled hypertension.
  • - Congestive heart failure.
  • - Severe chronic obstructive lung disease.
  • - Cerebrovascular disease.
  • - Pulmonary edema.
  • - History of carotis surgery or stenosis of carotid artery.
  • - Unstable hemodynamics.
  • - Pregnancy.
  • - Skin reaction to the NIRS sensor.
- Patient's refusal

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05961917
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bozyaka Training and Research Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Halide H Şahinkaya, MDÇağlar Ayar, MDAlper Tabanlı, MDZeki T Tekgül, MD
Principal Investigator Affiliation University of Health Sciences İzmir Bozyaka Education and Research HospitalUniversity of Health Sciences İzmir Bozyaka Education and Research HospitalUniversity of Health Sciences İzmir Bozyaka Education and Research HospitalUniversity of Health Sciences İzmir Bozyaka Education and Research Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Turkey
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Regional Cerebral Oxygen Saturation
Additional Details

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).

Arms & Interventions

Arms

Active Comparator: Group low PEEP

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

Active Comparator: Group high PEEP

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

Interventions

Other: - 5 cmH2O Positive end-expiratory pressure (PEEP)

PEEP will be set at 5 cmH2O

Other: - 10 cmH2O Positive end-expiratory pressure (PEEP)

PEEP will be set at 10 cmH2O

Contact a Trial Team

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International Sites

İzmir, Bozyaka, Turkey

Status

Recruiting

Address

University of Health Sciences İzmir Bozyaka Education and Research Hospital

İzmir, Bozyaka,

Site Contact

Halide H Şahinkaya, MD

[email protected]

+905058892157

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