Cerebral Oximetry and Anesthetic Technique

November 17, 2017 updated by: Antalya Training and Research Hospital

Evaluation of the Effects of Spinal Versus General Anesthesia on Transcranial Cerebral Oxygen Saturation in Geriatric Patients Undergoing Total Hip Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: general anesthesia
Patients in this group were randomized to receive general anesthesia.
Other: general anesthesia
effect of general anesthesia on transcranial regional cerebral oxygen saturation
Active Comparator: spinal anesthesia
Patients in this group were randomized to receive spinal anesthesia.
Other: spinal anesthesia
effect of spinal anesthesia on transcranial regional cerebral oxygen saturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in transcranial regional cerebral oxygenation (rSO2)
Time Frame: 60 minutes
Assessed every 5 minutes during the procedure
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post anesthetic complications
Time Frame: 1 day
During stay at the post anesthetic care unit. Any new neurological symptoms etc
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Training and Research Hospital

Investigators

  • Principal Investigator: Nilgun Kavrut Ozturk, MD, Antalya Training and Research Hospital
  • Principal Investigator: Ali Sait Kavakli, MD, Antalya Training and Research Hospital
  • Study Director: Ozge Dagdelen, MD, Antalya Training and Research Hospital
  • Principal Investigator: Ülkü Arslan, MD, Antalya Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

November 17, 2017

First Submitted That Met QC Criteria

November 17, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AntalyaTRH 17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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