The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery

Intracranial Neoplasm Clinical Trial

— Oxygenation  

Official title:

The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03714347
• Other study ID #: TÜTF-BAEK 2016/225
• Secondary ID: TÜTF-BAEK
• Status: Recruiting
• Phase: N/A
• Start date: December 28, 2016
• Est. completion date: January 2019

Study information

• Verified date: October 2018
• Source: Trakya University
• Contact: Sevtap Hekimoglu Sahin, Professor
• Email: sevtaphekimoglu[@]mynet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Intracranial Neoplasm

Intervention

Device:
• cerebral oxygen monitoring
probes will be placed on eyebrows on forehead
• routine monitoring
We will use routine monitoring intervention such as hate rate, arterial pressure, BIS. cerebral oxygen monitoring will not be applied to this group

Locations

Country	Name	City	State
Turkey	Trakya University	Edirne	Centrum

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebral oxygen monitoring data	cerebral oxygen monitoring will measure peroperative	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