NCT01083953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

8 months

First QC Date

March 8, 2010

Last Update Submit

December 2, 2015

Conditions

Airway Complications

Keywords

end tidal concentration

Outcome Measures

Primary Outcomes (1)

  • Optimal end tidal concentration of sevoflurane/ desflurane

    6 months

Secondary Outcomes (1)

  • presence of airway response

    10 mins after surgery

Study Arms (2)

Sevoflurane

EXPERIMENTAL

1 arm will receive sevoflurane at varying concentrations at which extubation is attempted according to the Dixon up and down method

Drug: Sevoflurane

Desflurane

EXPERIMENTAL

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

Interventions

SevofluraneDRUG

Comparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation

Sevoflurane
DesfluraneDRUG

Comparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation

Desflurane

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Upper respiratory tract symptoms in the previous 10 days
  • Risk of gastric oesophageal reflux or regurgitation
  • Known or predicted difficult airway
  • Poor dentition with high risk of damage
  • BMI \> 30 kg/m2
  • Refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

MeSH Terms

Interventions

SevofluraneDesflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Officials

  • Cindy Thomas Joseph

    Department of Anaesthesiology, UMMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

March 8, 2010

First Posted

March 10, 2010

Study Start

November 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

MY(1)