NCT01371968

Brief Summary

This study aims to determine the optimal dose of alfentanil in suppressing the airway reflexes during supreme LMA removal in anaesthetized adult.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 13, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

6 months

First QC Date

May 4, 2011

Last Update Submit

October 25, 2017

Conditions

Airway Response

Keywords

Alfentaniloptimal doselaryngeal mask airway

Outcome Measures

Primary Outcomes (1)

  • Optimal dose of alfentanil for successful LMA removal in spontaneously breathing anaesthetized adults

    6 months

Secondary Outcomes (1)

  • Number of patient with airway complication

    after administration of alfentanil and within 1 min of LMA removal

Study Arms (1)

alfentanil

EXPERIMENTAL

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

Drug: alfentanil

Interventions

alfentanilDRUG

Alfentanil is administered intravenously at the end of surgery.

Also known as: Rapifen
alfentanil

Eligibility Criteria

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

You may qualify if:

  • ASA I and II patients
  • Age 18 to 49 years old
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

MeSH Terms

Interventions

Alfentanil

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Lee Chew Kiok, MBBS

    Department of Anaesthesiogy, UMMC.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University of Malaya

Study Record Dates

First Submitted

May 4, 2011

First Posted

June 13, 2011

Study Start

February 1, 2011

Primary Completion

August 1, 2011

Study Completion

November 1, 2011

Last Updated

October 27, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

MY(1)