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Cerebral Oximetry and Anesthetic Technique

NCT ID: NCT03349658

Last Updated: 2017-11-21

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

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-08-31

Brief Summary

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The purpose of the study is to compare the effects of spinal and general anesthesia on transcranial regional cerebral oxygen saturation in geriatric patients undergoing total hip arthroplasty.

Detailed Description

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Geriatric patients who received anesthesia undergoing total hip arthroplasty were randomized by means of a computer-generated randomization order into two groups; general anesthesia group (Group 1) and spinal anesthesia group (Group 2). Before and after induction of the general or spinal anesthesia, patients were monitorized with near infrared spectroscopy for regional cerebral oxygen saturation. Findings were compared statistically.

Conditions

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Disorder of Hip Joint

Keywords

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total hip arthroplasty cerebral oxygen saturation general anesthesia spinal anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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general anesthesia

Patients in this group were randomized to receive general anesthesia.

Group Type ACTIVE_COMPARATOR

general anesthesia

Intervention Type OTHER

effect of general anesthesia on transcranial regional cerebral oxygen saturation

spinal anesthesia

Patients in this group were randomized to receive spinal anesthesia.

Group Type ACTIVE_COMPARATOR

spinal anesthesia

Intervention Type OTHER

effect of spinal anesthesia on transcranial regional cerebral oxygen saturation

Interventions

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general anesthesia

effect of general anesthesia on transcranial regional cerebral oxygen saturation

Intervention Type OTHER

spinal anesthesia

effect of spinal anesthesia on transcranial regional cerebral oxygen saturation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients who undergo elective total hip arthroplasty
* American Society of Anesthesiologists class 1 to 3
* Ability to consent

Exclusion Criteria

* Pulmonary disease
* History of allergic reaction to local anaesthetics
* Peripheral neuropathy
* Neurologic disease
* Coagulation disorders
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ozge Dagdelen, MD

Role: STUDY_DIRECTOR

Antalya Training and Research Hospital

Nilgun Kavrut Ozturk, MD

Role: PRINCIPAL_INVESTIGATOR

Antalya Training and Research Hospital

Ali Sait Kavakli, MD

Role: PRINCIPAL_INVESTIGATOR

Antalya Training and Research Hospital

Ülkü Arslan, MD

Role: PRINCIPAL_INVESTIGATOR

Antalya Training and Research Hospital

Other Identifiers

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AntalyaTRH 17

Identifier Type: -

Identifier Source: org_study_id