- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01371968
Optimal Dose of Alfentanil for Removal of Supreme Laryngeal Mask Airway During Emergence From Desflurane Anaesthesia
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
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:
|
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
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after administration of alfentanil and within 1 min of LMA removal
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lee Chew Kiok, MBBS, Department of Anaesthesiogy, UMMC.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Alfentanil LMA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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