The Quality of Recovery After General Anesthesia With Desflurane and Sevoflurane in Endoscopic Ureteral Lithotripsy

January 13, 2021 updated by: Gia Dinh People Hospital
The good quality of recovery after general anesthesia is one of goals for short procedures and ambulatory surgeries. The study's objective was to compare the quality of recovery after general anesthesia with desflurane and sevoflurane with laryngeal mask airway for endoscopic ureteral lithotripsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled trial. There were 60 cases of endoscopic ureteral lithotripsy under general anesthesia with laryngeal mask airway were enrolled. All cases were randomly divided into two group (desflurane or sevoflurane). Each group had 30 cases. Primary outcome was time to awakening. Secondary outcomes were time to wash-out of volatile anesthetics, time to extubation, irritation after awakening, and modified Aldrete score.

Statistical analysis was performed by using Kaplan-Meieir curve and log-rank test for time to adequate depth of anesthesia and time to awakening; t-test for time to wash-out of volatile anesthetics; chi-square test for depth of anesthesia by PRST score, irritation after awakening and Aldrete score; Fisher test for adverse effects of volatile anesthetics.

The research was approved by Gia Dinh People Hospital ethics committee

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Anesthesiology Department of Gia Dinh People 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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All eligible subjects who underwent endoscopic ureteral lithotripsy under general anesthesia
  • ASA I and II

Exclusion Criteria:

  • Contraindication to laryngeal mask airway.
  • Indication for conversion to tracheal intubation during surgery.
  • History of malignant hyperthermia.
  • Pregnancy.
  • Obese (BMI >25 kg/m2).
  • Substances abuse.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: D: maintain anesthesia with desflurane
D: maintain anesthesia with Suprane® (Desflurane) at 6%. Volatile concentration was titrated according to end-tidal MAC to maintain 0.7-1.3 MAC using end-tidal monitor of Dräger Primus anesthesia machine.
Other: Other
Compare time to awakening and quality of recovery after general anesthesia between two groups.
OTHER: S: maintain anesthesia with sevoflurane.
S: maintain anesthesia with Sevorane® (Sevoflurane) at 2%. Volatile concentration was titrated according to end-tidal MAC to maintain 0.7-1.3 MAC using end-tidal monitor of Dräger Primus anesthesia machine.
Other: Other
Compare time to awakening and quality of recovery after general anesthesia between two groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to awakening
Time Frame: After stopping volatile anesthetics to patient awakening, up to 30 minutes.
Time required for awakening
After stopping volatile anesthetics to patient awakening, up to 30 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to wash-out of volatile anesthetics
Time Frame: After stopping volatile anesthetics to complete wash-out of volatile anesthetics, up to 30 minutes
Time required for washing out volatile anesthetics
After stopping volatile anesthetics to complete wash-out of volatile anesthetics, up to 30 minutes
Time to extubation
Time Frame: After stopping volatile anesthetics to readiness for extubation, up to 30 minutes
Time required for successful extubation.
After stopping volatile anesthetics to readiness for extubation, up to 30 minutes
Irritation after awakening
Time Frame: After awakening to eligible discharge, up to 2 hours.
Aono score >2
After awakening to eligible discharge, up to 2 hours.
Adverse effects of volatile anesthetics
Time Frame: After providing volatile anesthetics until they were stopped, up to 90 minutes
Hypotension, cough, nausea and vomitting.
After providing volatile anesthetics until they were stopped, up to 90 minutes

Collaborators and Investigators

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

Sponsor

Gia Dinh People Hospital

Investigators

  • Study Chair: Thanh T. Nguyen, PhD, Gia Dinh People Hospital

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

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)

November 19, 2019

Primary Completion (ACTUAL)

May 7, 2020

Study Completion (ACTUAL)

May 7, 2020

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (ACTUAL)

January 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 81/CN-HĐĐĐ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

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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