Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01083953
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : December 3, 2015
Sponsor:
Collaborator:
Malaysian Society of Anaesthesiologists
Information provided by (Responsible Party):
Cindy Thomas Joseph, University of Malaya

Tracking Information
First Submitted Date  ICMJE March 8, 2010
First Posted Date  ICMJE March 10, 2010
Last Update Posted Date December 3, 2015
Study Start Date  ICMJE November 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2010)
Optimal end tidal concentration of sevoflurane/ desflurane [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01083953 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2010)
presence of airway response [ Time Frame: 10 mins after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimal End-Tidal (ET) Sevoflurane and Desflurane Concentration for Extubation of Supreme Laryngeal Mask Airway (LMA) in Adults
Official Title  ICMJE Optimal End-Tidal Concentration of Sevoflurane and Desflurane for Removal of Supreme Laryngeal Mask Airway in Anaesthetized Adults
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Airway Complications
Intervention  ICMJE
  • Drug: Sevoflurane
    Comparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation
  • Drug: Desflurane
    Comparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation
Study Arms  ICMJE
  • Experimental: Sevoflurane
    1 arm will receive sevoflurane at varying concentrations at which extubation is attempted according to the Dixon up and down method
    Intervention: Drug: Sevoflurane
  • 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
    Intervention: Drug: Desflurane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2015)
54
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2010)
70
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01083953
Other Study ID Numbers  ICMJE supreme sevo vs des
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cindy Thomas Joseph, University of Malaya
Study Sponsor  ICMJE University of Malaya
Collaborators  ICMJE Malaysian Society of Anaesthesiologists
Investigators  ICMJE
Principal Investigator: Cindy Thomas Joseph Department of Anaesthesiology, UMMC
PRS Account University of Malaya
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP