NCT03714347

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 28, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

1.9 years

First QC Date

October 18, 2018

Last Update Submit

October 19, 2018

Conditions

Intracranial Neoplasm

Keywords

cerebral oxygen monitoringintracranial surgerygeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

cerebral oxygen monitoringDEVICE

probes will be placed on eyebrows on forehead

Group Oxygen
routine monitoringDEVICE

We will use routine monitoring intervention such as hate rate, arterial pressure, BIS. cerebral oxygen monitoring will not be applied to this group

Group Control

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, Centrum, 22030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Emre Deren, MD

    Trakya University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sevtap Hekimoglu Sahin, Professor

CONTACT

sevtaphekimoglu@mynet.com

Beyhan Karamanlıoglu, professor

CONTACT

beykar@mynet.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 18, 2018

First Posted

October 22, 2018

Study Start

December 28, 2016

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

October 22, 2018

Record last verified: 2018-10

Locations

TU(1)