NCT05024084

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

September 5, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

26 days

First QC Date

August 13, 2021

Last Update Submit

September 17, 2021

Conditions

Anesthesia

Keywords

general anesthesialow flow anesthesiasevofluranedesflurane

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Anesthetic depth provided by the volatile anesthetic

    Change in Bispectral Index values at 5, 10, 15, 30, 60 and 120 minutes

Study Arms (2)

Group Sevoflurane

ACTIVE COMPARATOR

The patients in this arm will be given Sevoflurane (2-3%) as volatile anesthetic throughout the duration of anesthesia.

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

Group Desflurane

ACTIVE COMPARATOR

The patients in this arm will be given Desflurane (7-8%) as volatile anesthetic throughout the duration of anesthesia.

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

Interventions

Minimal flow anesthesia (fresh gas flow <0.5 l/min) using SevofluranePROCEDURE

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

Group Sevoflurane
Minimal flow anesthesia (fresh gas flow <0.5 l/min) using DesfluranePROCEDURE

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

Group Desflurane

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk University Dr. Rıdvan Ege Hospital

Ankara, 06520, Turkey (Türkiye)

RECRUITING

Related 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.

    PMID: 33103139BACKGROUND

  • 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.

    PMID: 26579522BACKGROUND

Study Officials

  • Baturay K Kazbek, Ass. Prof.

    Ufuk University Faculty of Medicine Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Baturay K Kazbek, Ass. Prof.

CONTACT

+903122044000bkkazbek@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 13, 2021

First Posted

August 27, 2021

Study Start

September 5, 2021

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

September 20, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)