Clinical trial NCT05961917: Effect of Different Positive End Expiratory Pressures on Regional Cerebral Oxygen Saturation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Cerebral Oxygen Saturation
Keywords: regional cerebral oxygen saturation
PEEP
craniotomy
near-infrared spectroscopy
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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).

Eligibility 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

Primary outcomes:
measure: regional cerebral oxygen saturation (SrO2) period 1
timeFrame: Pre-induction
measure: regional cerebral oxygen saturation (SrO2) period 2
timeFrame: Up to 5 minutes after anethesia induction
measure: regional cerebral oxygen saturation (SrO2) period 3
timeFrame: From skull-pinning to final head position
measure: regional cerebral oxygen saturation (SrO2) period 4
timeFrame: Just before dura opening
measure: regional cerebral oxygen saturation (SrO2) period 5
timeFrame: Up to 5 minutes of dura opening
measure: regional cerebral oxygen saturation (SrO2) period 6
timeFrame: During surgical resection
measure: regional cerebral oxygen saturation (SrO2) period 7
timeFrame: Up to 5 minutes of dura closure
measure: regional cerebral oxygen saturation (SrO2) period 8
timeFrame: Within 5 minutes after the surgery
measure: regional cerebral oxygen saturation (SrO2) period 9
timeFrame: Within 5 minutes after end of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: University of Health Sciences İzmir Bozyaka Education and Research Hospital
state: Bozyaka
Study officials:
affiliation: University of Health Sciences İzmir Bozyaka Education and Research Hospital
name: Halide H Şahinkaya, MD
role: STUDY_CHAIR
affiliation: University of Health Sciences İzmir Bozyaka Education and Research Hospital
name: Çağlar Ayar, MD
role: STUDY_CHAIR
affiliation: University of Health Sciences İzmir Bozyaka Education and Research Hospital
name: Alper Tabanlı, MD
role: STUDY_CHAIR
affiliation: University of Health Sciences İzmir Bozyaka Education and Research Hospital
name: Zeki T Tekgül, MD
role: STUDY_CHAIR
References:
citation: Kemerci PU, Demir A, Aydinli B, Guclu CY, Karadeniz U, Cicek OF, Tasoglu I, Ozgok A. 10 cm H2O PEEP application in laparoscopic surgery and cerebral oxygenation: a comparative study with INVOS and FORESIGHT. Surg Endosc. 2016 Mar;30(3):971-8. doi: 10.1007/s00464-015-4277-8. Epub 2015 Jun 23.
citation: Chen H, Zhou XF, Zhou DW, Zhou JX, Yu RG. Effect of increased positive end-expiratory pressure on intracranial pressure and cerebral oxygenation: impact of respiratory mechanics and hypovolemia. BMC Neurosci. 2021 Nov 25;22(1):72. doi: 10.1186/s12868-021-00674-9.
citation: Calderon-Arnulphi M, Alaraj A, Slavin KV. Near infrared technology in neuroscience: past, present and future. Neurol Res. 2009 Jul;31(6):605-14. doi: 10.1179/174313209X383286.