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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05024084
Other study ID # 2021-009
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 5, 2021
Est. completion date October 1, 2021

Study information

Verified date September 2021
Source Ufuk University
Contact Baturay K Kazbek, Ass. Prof.
Phone +903122044000
Email bkkazbek@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date October 1, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Minimal flow anesthesia (fresh gas flow <0.5 l/min) using Sevoflurane
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
Minimal flow anesthesia (fresh gas flow <0.5 l/min) using Desflurane
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

Locations

Country Name City State
Turkey Ufuk University Dr. Ridvan Ege Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ufuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time until extubation Time interval between discontinuation of the volatile anesthetics and removal of the endotracheal tube Up to 10 minutes after discontinuation of the volatile anesthetic
Primary Time until eye opening Time interval between discontinuation of the volatile anesthetics and eye opening with verbal command Up to 20 minutes after discontinuation of the volatile anesthetic
Primary Time until transfer readiness 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 Anesthetic depth provided by the volatile anesthetic Anesthetic depth as measured by Bispectral Index Change in Bispectral Index values at 5, 10, 15, 30, 60 and 120 minutes
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