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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01371968
First Posted: June 13, 2011
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Malaysian Society of Anaesthesiologists
Information provided by (Responsible Party):
Lee Chew Kiok, University of Malaya
  Purpose
This study aims to determine the optimal dose of alfentanil in suppressing the airway reflexes during supreme LMA removal in anaesthetized adult.

Condition Intervention
Airway Response Drug: alfentanil

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Optimal Dose of Alfentanil for Removal of Supreme Laryngeal Mask Airway During Emergence From Desflurane Anaesthesia

Resource links provided by NLM:


Further study details as provided by Lee Chew Kiok, University of Malaya:

Primary Outcome Measures:
  • Optimal dose of alfentanil for successful LMA removal in spontaneously breathing anaesthetized adults [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Number of patient with airway complication [ Time Frame: after administration of alfentanil and within 1 min of LMA removal ]

Enrollment: 30
Study Start Date: February 2011
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: alfentanil
Alfentanil is administered intravenously at the end of surgery.
Other Name: Rapifen

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371968


Locations
Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Malaysian Society of Anaesthesiologists
Investigators
Principal Investigator: Lee Chew Kiok, MBBS Department of Anaesthesiogy, UMMC.
  More Information

Responsible Party: Lee Chew Kiok, University of Malaya
ClinicalTrials.gov Identifier: NCT01371968     History of Changes
Other Study ID Numbers: Alfentanil LMA
First Submitted: May 4, 2011
First Posted: June 13, 2011
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

Keywords provided by Lee Chew Kiok, University of Malaya:
Alfentanil
optimal dose
laryngeal mask airway

Additional relevant MeSH terms:
Desflurane
Alfentanil
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous