Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961917
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2023-06-30
Brief Title:
Effect of Different Positive End Expiratory Pressures on Regional Cerebral Oxygen Saturation
Sponsor:
Bozyaka Training and Research Hospital
Organization:
Bozyaka Training and Research Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Cerebralsomatic 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 025 mcgkgmin will be started two minutes before the induction After preoxygenation with 6 Lmin oxygen for 5 minutes general anesthesia induction for patients in both groups will be held with intravenous 2 mgkg propofol Rocuronium bromide 06 mgkg 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 mLkg inspired oxygen fraction FiO2 04 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 mLkg inspired oxygen fraction FiO2 04 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 005-2 mcg kgmin and propofol with a dose of 50-200 mcgkgmin 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 andor 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 05 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 mgkg 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
In group low PEEP the patients settings of mechanical ventilation will be as tidal volume 6-8 mLkg inspired oxygen fraction FiO2 04 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 mLkg inspired oxygen fraction FiO2 04 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 005-2 mcg kgmin and propofol with a dose of 50-200 mcgkgmin 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 andor 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 05 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 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None