Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth

September 17, 2021 updated by: Baturay Kansu Kazbek, Ufuk University

Comparison of Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery Parameters and Anesthetic Depth: a Randomized Prospective Study

Minimal flow anesthesia has economic and environmental advantages in addition to providing earlier recovery following general anesthesia. There is a paucity of data concerning the effect of minimal flow anesthesia (fresh gas flow <0,5 l/min) on recovery parameters. The primary objective of this study is to compare the recovery parameters of desflurane and sevoflurane in minimal flow anesthesia while the secondary objective is to compare the effect of these agents on anesthetic depth using bispectral index.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

130

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 Contact

  • Name: Baturay K Kazbek, Ass. Prof.
  • Phone Number: 4099 +903122044000
  • Email: bkkazbek@gmail.com

Study Locations

      • Ankara, Turkey, 06520
        • Recruiting
        • Ufuk University Dr. Rıdvan Ege Hospital
        • Contact:

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:

  • Ages between 18 and 65
  • Patients undergoing elective surgery under general anesthesia
  • Patients with an American Society of Anesthesiologists Classification I or II

Exclusion Criteria:

  • Patient refusal
  • Emergency surgery
  • Patients with a contraindication for minimal flow anesthesia
  • Uncontrolled diabetes mellitus
  • History of serious systemic disease (cardiac, pulmonary, hepatic)
  • Utilization of another analgesic technique such as central or peripheral nerve blocks

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Sevoflurane
The patients in this arm will be given Sevoflurane (2-3%) as volatile anesthetic throughout the duration of anesthesia.
Sevoflurane will be used for the maintenance of general anesthesia which will be carried out using a fresh gas flow of less than 0,5 l/min
Active Comparator: Group Desflurane
The patients in this arm will be given Desflurane (7-8%) as volatile anesthetic throughout the duration of anesthesia.
Desflurane will be used for the maintenance of general anesthesia which will be carried out using a fresh gas flow of less than 0,5 l/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time until extubation
Time Frame: Up to 10 minutes after discontinuation of the volatile anesthetic
Time interval between discontinuation of the volatile anesthetics and removal of the endotracheal tube
Up to 10 minutes after discontinuation of the volatile anesthetic
Time until eye opening
Time Frame: Up to 20 minutes after discontinuation of the volatile anesthetic
Time interval between discontinuation of the volatile anesthetics and eye opening with verbal command
Up to 20 minutes after discontinuation of the volatile anesthetic
Time until transfer readiness
Time Frame: Up to 45 minutes after discontinuation of the volatile anesthetic
Time interval between discontinuation of the volatile anesthetics and Aldrete score reaching 9 or greater
Up to 45 minutes after discontinuation of the volatile anesthetic

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anesthetic depth provided by the volatile anesthetic
Time Frame: Change in Bispectral Index values at 5, 10, 15, 30, 60 and 120 minutes
Anesthetic depth as measured by Bispectral Index
Change in Bispectral Index values at 5, 10, 15, 30, 60 and 120 minutes

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Baturay K Kazbek, Ass. Prof., Ufuk University Faculty of Medicine Department of Anesthesiology and Reanimation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

September 5, 2021

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

August 13, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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