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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University of Malaya.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Malaysian Society of Anaesthesiologists
Information provided by:
University of Malaya
ClinicalTrials.gov Identifier:
NCT01371968
First received: May 4, 2011
Last updated: June 10, 2011
Last verified: June 2011
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
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 University of Malaya:

Primary Outcome Measures:
  • Optimal dose of alfentanil for successful LMA removal in spontaneously breathing anaesthetized adults [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nunber of patient with airway complication [ Time Frame: after administration of alfentanil and within 1 min of LMA removal ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2011
Estimated Study Completion Date: November 2011
Estimated 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

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371968

Contacts
Contact: Lee Chew Kiok, MBBS 0162737229 cklee1127@yahoo.com
Contact: Wang Chew Yin 0192340232 wangcy1836@gmail.com

Locations
Malaysia
University Malaya Medical Centre Recruiting
Lembah Pantai, Kuala Lumpur, Malaysia, 59100
Contact: Lee Chew Kiok, MBBS    0162737229    cklee1127@yahoo.com   
Contact: Wang Chew Yin    0192340232    wangcy1836@gmail.com   
Principal Investigator: Lee Chew Kiok, MBBS         
Sponsors and Collaborators
University of Malaya
Malaysian Society of Anaesthesiologists
Investigators
Principal Investigator: Lee Chew Kiok, MBBS Department of Anaesthesiogy, UMMC.
  More Information

No publications provided

Responsible Party: Dr Lee Chew Kiok, University Malaya Medical centre
ClinicalTrials.gov Identifier: NCT01371968     History of Changes
Other Study ID Numbers: Alfentanil LMA
Study First Received: May 4, 2011
Last Updated: June 10, 2011
Health Authority: Malaysia: Ministry of Health

Keywords provided by University of Malaya:
Alfentanil
optimal dose
laryngeal mask airway

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

ClinicalTrials.gov processed this record on July 23, 2014