- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05024084
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
Status
Recruiting
Conditions
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:
- Baturay K Kazbek, Ass. Prof.
- Phone Number: 4099 +903122044000
- Email: bkkazbek@gmail.com
-
-
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.
General Publications
- Taskin D, Gedik E, Kayhan Z. Effects of Minimal Flow Sevoflurane or Desflurane Anaesthesia on Hemodynamic Parameters, Body Temperature and Anaesthetic Consumption. Turk J Anaesthesiol Reanim. 2020 Oct;48(5):356-363. doi: 10.5152/TJAR.2020.39699. Epub 2020 May 5.
- Werner JG, Castellon-Larios K, Thongrong C, Knudsen BE, Lowery DS, Antor MA, Bergese SD. Desflurane Allows for a Faster Emergence When Compared to Sevoflurane without Affecting the Baseline Cognitive Recovery Time. Front Med (Lausanne). 2015 Oct 28;2:75. doi: 10.3389/fmed.2015.00075. eCollection 2015.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-009
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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