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

Airway Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083953
• Other study ID #: supreme sevo vs des
• Status: Completed
• Phase: N/A
• First received: March 8, 2010
• Last updated: December 2, 2015
• Start date: November 2009
• Est. completion date: July 2010

Study information

• Verified date: December 2015
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Airway Complications

Intervention

Drug:
• Sevoflurane
Comparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation
• Desflurane
Comparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan

Sponsors (2)

Lead Sponsor	Collaborator
University of Malaya	Malaysian Society of Anaesthesiologists

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal end tidal concentration of sevoflurane/ desflurane		6 months	No
Secondary	presence of airway response		10 mins after surgery	No