Comparison of Volatile Anesthetics on Cerebral Oxygenation During Controlled Hypotension

August 18, 2020 updated by: Perihan Ekmekçi, Ufuk University

Comparison of Effects of Sevoflurane and Desflurane on Cerebral Oxygenation During Controlled Hypotension

Controlled hypotension is a preferred method for reducing surgical bleeding during septoplasty operations however, the level of hypotension and bradycardia should not disrupt cerebral oxygenation. On this account, the investigators aim to investigate the effects of different volatile anesthetics combined with a short-acting opioid on cerebral oxygenation during controlled hypotension using near infrared spectroscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ufuk University Hospital

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients in American Society of Anesthesiology (ASA) classification I and II
  • Patients undergoing elective septoplasty operation

Exclusion Criteria:

  • Patients in ASA classification III and higher
  • Emergency surgery
  • Patients in New York Heart Association classification III-IV
  • Patients with known allergy to drugs used in the study

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sevoflurane
Drug: Sevoflurane
Sevoflurane %2-3 for general anesthesia maintenance
Experimental: Desflurane
Drug: Desflurane
Desflurane %6-8 for general anesthesia maintenance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral oxygen saturation as measured by Near Infrared Spectroscopy
Time Frame: Duration of surgery
The effect of sevoflurane and desflurane on NIRS values
Duration of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total remifentanil consumption as measured in micrograms
Time Frame: Duration of surgery
Duration of surgery
The effect of anesthetics on hemodynamic variables
Time Frame: Duration of surgery
The effects of sevoflurane and desflurane on mean arterial pressure
Duration of surgery
The effect of anesthetics on hemodynamic variables
Time Frame: Duration of surgery
The effects of sevoflurane and desflurane on heart rate
Duration of surgery
The effect of anesthetics on hemodynamic variables
Time Frame: Duration of surgery
The effects of sevoflurane and desflurane on bispectral index
Duration of surgery

Collaborators and Investigators

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

Sponsor

Ufuk University

Investigators

  • Principal Investigator: Ülkü C Köksoy, MD, Fellow

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

June 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

June 24, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 15, 2016

Study Record Updates

Last Update Posted (Actual)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016Sept

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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