The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery

NCT ID: NCT03714347

Last Updated: 2018-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-28

Study Completion Date

2019-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Intracranial Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group Control

routine monitoring will be applied to this group

Group Type ACTIVE_COMPARATOR

routine monitoring

Intervention Type DEVICE

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

Group Oxygen

cerebral oxygen monitoring is applied to this group

Group Type ACTIVE_COMPARATOR

cerebral oxygen monitoring

Intervention Type DEVICE

probes will be placed on eyebrows on forehead

Interventions

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cerebral oxygen monitoring

probes will be placed on eyebrows on forehead

Intervention Type DEVICE

routine monitoring

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trakya University

OTHER

Sponsor Role lead

Responsible Party

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Sevtap Hekimoglu Sahin

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emre Deren, MD

Role: PRINCIPAL_INVESTIGATOR

Trakya University

Locations

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Trakya University

Edirne, Centrum, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sevtap Hekimoglu Sahin, Professor

Role: CONTACT

Beyhan Karamanlıoglu, professor

Role: CONTACT

Facility Contacts

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Sevtap Hekimoglu Sahin, Professor

Role: primary

Beyhan Karamanlıoglu, Professor

Role: backup

Other Identifiers

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TÜTF-BAEK

Identifier Type: REGISTRY

Identifier Source: secondary_id

TÜTF-BAEK 2016/225

Identifier Type: -

Identifier Source: org_study_id

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