search
Back to results

The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery (Oxygenation)

Primary Purpose

Intracranial Neoplasm

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
cerebral oxygen monitoring
routine monitoring
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Neoplasm focused on measuring cerebral oxygen monitoring, intracranial surgery, general anesthesia

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Trakya UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group Control

Group Oxygen

Arm Description

routine monitoring will be applied to this group

cerebral oxygen monitoring is applied to this group

Outcomes

Primary Outcome Measures

cerebral oxygen monitoring data
cerebral oxygen monitoring will measure peroperative

Secondary Outcome Measures

Full Information

First Posted
October 18, 2018
Last Updated
October 19, 2018
Sponsor
Trakya University
search

1. Study Identification

Unique Protocol Identification Number
NCT03714347
Brief Title
The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery
Acronym
Oxygenation
Official Title
The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 28, 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trakya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Neoplasm
Keywords
cerebral oxygen monitoring, intracranial surgery, general anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Control
Arm Type
Active Comparator
Arm Description
routine monitoring will be applied to this group
Arm Title
Group Oxygen
Arm Type
Active Comparator
Arm Description
cerebral oxygen monitoring is applied to this group
Intervention Type
Device
Intervention Name(s)
cerebral oxygen monitoring
Intervention Description
probes will be placed on eyebrows on forehead
Intervention Type
Device
Intervention Name(s)
routine monitoring
Intervention Description
We will use routine monitoring intervention such as hate rate, arterial pressure, BIS. cerebral oxygen monitoring will not be applied to this group
Primary Outcome Measure Information:
Title
cerebral oxygen monitoring data
Description
cerebral oxygen monitoring will measure peroperative
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sevtap Hekimoglu Sahin, Professor
Email
sevtaphekimoglu@mynet.com
First Name & Middle Initial & Last Name or Official Title & Degree
Beyhan Karamanlıoglu, professor
Email
beykar@mynet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emre Deren, MD
Organizational Affiliation
Trakya University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trakya University
City
Edirne
State/Province
Centrum
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sevtap Hekimoglu Sahin, Professor
Email
sevtaphekimoglu@mynet.com
First Name & Middle Initial & Last Name & Degree
Beyhan Karamanlıoglu, Professor
Email
beykar@mynet.com

12. IPD Sharing Statement

Learn more about this trial

The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery

We'll reach out to this number within 24 hrs