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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Malaya.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Malaysian Society of Anaesthesiologists
Information provided by:
University of Malaya
ClinicalTrials.gov Identifier:
NCT01083953
First received: March 8, 2010
Last updated: March 9, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention
Airway Complications
 Drug: Sevoflurane
Drug: Desflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Optimal End-Tidal Concentration of Sevoflurane and Desflurane for Removal of Supreme Laryngeal Mask Airway in Anaesthetized Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Malaya:

Primary Outcome Measures:
  • Optimal end tidal concentration of sevoflurane/ desflurane [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • presence of airway response [ Time Frame: 10 mins after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: November 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083953

Contacts
Contact: Cindy Thomas Joseph +60122067060 cindytj@gmail.com
Contact: Wang Chew Yin +60192340232 wangcy1836@gmail.com

Locations
Malaysia
University Malaya Medical Centre Recruiting
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
Contact: wang Chew Yin     +60192340232     wangcy1836@gmail.com    
Principal Investigator: Cindy Thomas Joseph            
Sponsors and Collaborators
University of Malaya
Malaysian Society of Anaesthesiologists
Investigators
Principal Investigator: Cindy Thomas Joseph Department of Anaesthesiology, UMMC
  More Information

No publications provided

Responsible Party: Dr Cindy Thomas Joseph, Department of Anaesthesiology, University of Malaya
ClinicalTrials.gov Identifier: NCT01083953     History of Changes
Other Study ID Numbers: supreme sevo vs des
Study First Received: March 8, 2010
Last Updated: March 9, 2010
Health Authority: Malaysia: Ministry of Health

Keywords provided by University of Malaya:
end tidal concentration

Additional relevant MeSH terms:
Desflurane
Sevoflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on May 23, 2013