Optimal Dose of Alfentanil for Removal of Supreme Laryngeal Mask Airway During Emergence From Desflurane Anaesthesia

October 25, 2017 updated by: Lee Chew Kiok, University of Malaya
This study aims to determine the optimal dose of alfentanil in suppressing the airway reflexes during supreme LMA removal in anaesthetized adult.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The removal of LMA may be associated with coughing, biting, agitation and airway complication such as laryngospasm. Thus it is advisable to remove the LMA when the patient is breathing spontaneously and when the airway reflexes are still depressed. A number of techniques have been used to prevent this adverse emergence phenomenon, such as removing the tube while the patient is in deep plane of anaesthesia or administration of local anaesthetic and intravenous opioids

The administration of intravenous opioids before emergence may be useful for preventing cough, agitation and hemodynamic response. Alfentanyl is proven to suppress cough and agitation during the endotracheal tube emergence. However, its use in suppressing cough in LMA patient has not been evaluated.

Study Type

Interventional

Enrollment (Actual)

30

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

      • Kuala Lumpur, 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 I and II patients
  2. Age 18 to 49 years old
  3. Minor elective day care surgery (> 20 minute and less than 2 hours) which require local anaesthetic infiltration and does not require use of long acting opioids.

Exclusion Criteria:

  1. Potential difficult airway
  2. Reactive airway disease or sign and symptoms of upper respiratory tract infection.
  3. History of cardiac, pulmonary and renal diseases
  4. Body Mass Index > 30 kgm2.
  5. Risk of aspiration.
  6. Poor dentition with high risk of damage.
  7. Patient refusal.

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: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: alfentanil
patient will received a dose of alfentanil in which the dose of alfentanil is determined by response of previously tested patient using Dixon up and down methods
Alfentanil is administered intravenously at the end of surgery.
Other Names:
  • Rapifen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Optimal dose of alfentanil for successful LMA removal in spontaneously breathing anaesthetized adults
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patient with airway complication
Time Frame: after administration of alfentanil and within 1 min of LMA removal
after administration of alfentanil and within 1 min of LMA removal

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Lee Chew Kiok, MBBS, Department of Anaesthesiogy, 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

February 1, 2011

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

May 4, 2011

First Submitted That Met QC Criteria

June 10, 2011

First Posted (ESTIMATE)

June 13, 2011

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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