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Status unknownNCT03714347OxygenationUpdated Oct 22, 2018

The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery

An interventional study of cerebral oxygen monitoring and routine monitoring in Intracranial Neoplasm, sponsored by Trakya University. Status unknown at 1 site in Turkey. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-22.

Sponsored by Trakya University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Dec 2016, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
25 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Intracranial Neoplasm

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Keywords

  • cerebral oxygen monitoring
  • intracranial surgery
  • general anesthesia
03

In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's planned enrollment of 100 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

Trakya University is the lead sponsor of 150 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Under GKS 15
  • heart failure,
  • renal insufficiency,
  • liver failure,
  • congenital neurological deficits
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Group Control

    routine monitoring will be applied to this group

    Device: routine monitoring

  • Active comparator
    Group Oxygen

    cerebral oxygen monitoring is applied to this group

    Device: cerebral oxygen monitoring

Interventions

  • Devicecerebral oxygen monitoring

    probes will be placed on eyebrows on forehead

  • Deviceroutine monitoring

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

06

What researchers measure

Primary outcomes

  1. cerebral oxygen monitoring data

    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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03714347
Lead sponsor
Trakya University
Responsible party
Sevtap Hekimoglu Sahin (Clinical Professor, Trakya University) — Principal investigator
First posted
Oct 22, 2018
Start date
Dec 28, 2016
Primary completion
Dec 2018 (estimated)
Completion
Jan 2019 (estimated)
Last update
Oct 22, 2018

Study contacts

Sevtap Hekimoglu Sahin, Professor
Contact
sevtaphekimoglu@mynet.com
Beyhan Karamanlıoglu, professor
Contact
beykar@mynet.com
Emre Deren, MD
principal investigator · Trakya University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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