The Effect of Cerebral Oxygenation on Postoperative Recov... | NCT03714347

Studies
The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery

NCT03714347

Sponsor

Trakya University

Status

Unknown status

Last Update Posted

Oct 22, 2018Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Intracranial Neoplasm

Interventions

cerebral oxygen monitoring
routine monitoring

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TÜTF-BAEK	Registry Identifier	Local Ethic

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 28, 2016Actual

Primary Completion Date

Dec 2018Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Oct 18, 2018

First Submission Date that Met QC Criteria

Oct 19, 2018

First Posted Date

Oct 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2018

Last Update Posted Date

Oct 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group Control	Active Comparator	routine monitoring will be applied to this group	Device: routine monitoring
Group Oxygen	Active Comparator	cerebral oxygen monitoring is applied to this group	Device: cerebral oxygen monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cerebral oxygen monitoring	Device	probes will be placed on eyebrows on forehead	Group Oxygen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sevtap Hekimoglu Sahin, Professor	Contact			sevtaphekimoglu@mynet.com
Beyhan Karamanlıoglu, professor	Contact			beykar@mynet.com

Overall Officials

Name	Affiliation	Role
Emre Deren, MD	Trakya University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Trakya University	Recruiting	Edirne	Centrum	22030	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided