Optimal End-Tidal (ET) Sevoflurane and Desflurane Concentration for Extubation of Supreme Laryngeal Mask Airway (LMA) in Adults

December 2, 2015 updated by: Cindy Thomas Joseph, University of Malaya

Optimal End-Tidal Concentration of Sevoflurane and Desflurane for Removal of Supreme Laryngeal Mask Airway in Anaesthetized Adults

The purpose of this study is to determine the optimal volatile anaesthetic (sevoflurane and desflurane) to remove a Supreme LMA in adults in which there is minimal airway response.

Null hypothesis: there is no significant difference between the optimal end tidal concentration of sevoflurane and desflurane for Supreme LMA removal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The manufactures' instructions for removal of the LMA recommend waiting until protective reflexes have returned. However, the appropriate timing for removal remains controversial. A more frequent incidence of airway hyperreactivity and complications has been reported by some studies when the LMA was removed in the awake state versus the anesthetized state. Techniques that reduce the time from LMA removal to the return of protective airway reflexes would minimize the risk of aspiration, contamination, or airway obstruction.

With increasingly common use of Supreme LMA in anaesthetic practice, a safe and suitable depth for removal of the Supreme LMA requires research.

Thus the determination of the optimal end-tidal concentration of commonly used volatile agents ie. Sevoflurane and Desflurane for Supreme LMA removal requires research, both for patient safety and minimising anaesthetic costs in dealing with airway complications.

Study Type

Interventional

Enrollment (Actual)

54

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

  • Malaysia
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
        • University Malaya Medical Centre

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 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ASA 1-2 patients
  2. Age 18 - 49 years old
  3. Elective surgery of short duration ( < 2 hours ) which require local anaesthetic infiltration

Exclusion Criteria:

  1. Upper respiratory tract symptoms in the previous 10 days
  2. Risk of gastric oesophageal reflux or regurgitation
  3. Known or predicted difficult airway
  4. Poor dentition with high risk of damage
  5. BMI > 30 kg/m2
  6. Refusing to participate

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sevoflurane
1 arm will receive sevoflurane at varying concentrations at which extubation is attempted according to the Dixon up and down method
Drug: Sevoflurane
Comparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation
EXPERIMENTAL: Desflurane
1 arm will receive desflurane at varying end tidal concentration at which extubation will be attempted according to Dixon up and down method
Drug: Desflurane
Comparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Optimal end tidal concentration of sevoflurane/ desflurane
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
presence of airway response
Time Frame: 10 mins after surgery
10 mins after surgery

Collaborators and Investigators

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

Sponsor

University of Malaya

Collaborators

Malaysian Society of Anaesthesiologists

Investigators

  • Principal Investigator: Cindy Thomas Joseph, Department of Anaesthesiology, UMMC

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

November 1, 2009

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (ESTIMATE)

March 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • supreme sevo vs des

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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