The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery

Not Applicable

• Conditions: Intracranial Neoplasm
• Interventions: Device: routine monitoring; Device: cerebral oxygen monitoring

• Registration Number: NCT03714347
• Lead Sponsor: Trakya University

Brief Summary

The aim of this study was to investigate the effect of cerebral oxygenation on postoperative compilation in intracranial surgery.

Detailed Description

Patients undergoing intracranial surgery will be divided into two groups; group (Group Control n = 100) and cerebral oxygenation monitoring group (Group Oxygen). all hemodynamic parameters such as systolic blood pressure and diastolic blood pressure, oxygen saturation, Et CO2, SpO2;% and BIS during anesthesia during anesthesia will be recorded intraoperatively and 10 postoperatively in 5 min intervals. After extubation, Modified Aldrete Score, GKS (Glasgow Coma Scale), Ramsey Sedation Scale (RSS), nausea-vomiting and pain will be recorded in the recovery room. Pain assessment will be done with Visual Analog Scale (VAS). Patient satisfaction will be recorded. MMST (mini mental state test) and ASEM (antisaccadic eye movement test) tests will be performed preoperatively and postoperatively at 1st, 2nd and 3rd days.

Study Timeline

• Study Start: 2016-12-28
• Status Verified: 2018-10
• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-19
• Last Update Submitted: 2018-10-19
• Study First Posted: 2018-10-22
• Last Update Posted: 2018-10-22
• Primary Completion: 2018-12
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Intracranial surgery will be performed
• Age 25-75
• ASA in the I-II-III risk group

Exclusion Criteria

• Under GKS 15
• heart failure,
• renal insufficiency,
• liver failure,
• congenital neurological deficits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Control	routine monitoring	routine monitoring will be applied to this group
Group Oxygen	cerebral oxygen monitoring	cerebral oxygen monitoring is applied to this group

Primary Outcome Measures

Name	Time	Method
cerebral oxygen monitoring data	cerebral oxygen values reported will be measured at 10 min intervals (intraoperative) and It would be reported by the first postoperative 10 minute intervals up to 30 minutes	cerebral oxygen monitoring will measure peroperative

Trial Locations

Locations (1)

Trakya University; 🇹🇷 Edirne, Centrum, Turkey