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The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery

T

Trakya University

Status

Unknown

Conditions

Intracranial Neoplasm

Treatments

Device: cerebral oxygen monitoring
Device: routine monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT03714347
TÜTF-BAEK (Registry Identifier)
TÜTF-BAEK 2016/225

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

25 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Group Control
Active Comparator group
Description:
routine monitoring will be applied to this group
Treatment:
Device: routine monitoring
Group Oxygen
Active Comparator group
Description:
cerebral oxygen monitoring is applied to this group
Treatment:
Device: cerebral oxygen monitoring

Trial contacts and locations

1

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Central trial contact

Sevtap Hekimoglu Sahin, Professor; Beyhan Karamanlıoglu, professor

Data sourced from clinicaltrials.gov

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