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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01371968
Other study ID # Alfentanil LMA
Secondary ID
Status Completed
Phase N/A
First received May 4, 2011
Last updated October 25, 2017
Start date February 2011
Est. completion date November 2011

Study information

Verified date October 2017
Source University of Malaya
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 2011
Est. primary completion date August 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 49 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
alfentanil
Alfentanil is administered intravenously at the end of surgery.

Locations

Country Name City State
Malaysia University Malaya Medical Centre Kuala Lumpur

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 dose of alfentanil for successful LMA removal in spontaneously breathing anaesthetized adults 6 months
Secondary Number of patient with airway complication after administration of alfentanil and within 1 min of LMA removal