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Dexmedetomidine for Laryngeal Mask Airway Insertion

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ClinicalTrials.gov Identifier: NCT01852539
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : April 22, 2014
Sponsor:
Information provided by (Responsible Party):
Jong Yeop Kim, Ajou University School of Medicine

Brief Summary:
The investigators attempted to determine the optimal dose of dexmedetomidine required for the successful insertion of LMA during propofol induction without a neuromuscular blocking agent.

Condition or disease Intervention/treatment Phase
Drug Usage Drug: dexmedetomidine Drug: propofol Device: laryngeal mask airway (LMA) Phase 4

Detailed Description:
After a predetermined bolus dose of dexmedetomidine was injected over 2 min, anesthesia was induced with propofol 2.0 mg/kg. After confirming the loss of eyelash reflex and the bispectral index (BIS) score decreased below 60, the insertion of LMA was attempted.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Optimal Dose of Dexmedetomidine for Laryngeal Mask Airway Insertion During Propofol Induction
Study Start Date : July 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dexmedetomidine
After intravenous infusion of dexmedetomidine for 2 min, propofol 2.0 mg/kg was administrated. And laryngeal mask airway device was inserted(LMA # 3,4).
Drug: dexmedetomidine
The dose of dexmedetomidine was determined by modified Dixon's up-and-down method, starting from 0.5 μg/kg (0.1 μg/kg as a step size).
Other Name: precedex

Drug: propofol
Propofol 2.0 mg/kg was administrated
Other Name: 2% fresofol

Device: laryngeal mask airway (LMA)
The insertion of laryngeal mask airway (LMA) was attempted, after confirming the loss of eyelash reflex,the bispectral index (BIS) score decreased below 60.




Primary Outcome Measures :
  1. successful insertion of LMA [ Time Frame: from baseline to 2 min after insertion of LMA (participants will be followed for the duration of anesthetic induction, an expected average of 10 min). ]
    the response of patients to the insertion of LMA (classified as either 'movement' or 'no movement') during infusion of dexmedetomidine and propofol.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II patients undergoing general anesthesia for short elective surgery (<1 hr)

Exclusion Criteria:

  • G-E reflux
  • obesity (BMI>30)
  • anticipated difficult airway

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): NCT01852539


Locations
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Korea, Republic of
Ajou University School of Medicine
Suwon, Korea, Republic of, 443-721
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Study Director: Jong Yeop Kim, MD Ajou University School of Medicine
Publications of Results:
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Responsible Party: Jong Yeop Kim, Associate professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01852539    
Other Study ID Numbers: AJIRB-MED-CT4-13-045
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: April 22, 2014
Last Verified: April 2014
Keywords provided by Jong Yeop Kim, Ajou University School of Medicine:
LMA insertion
dexmedetomidine
propofol
Additional relevant MeSH terms:
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Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action