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The Effect of Dexmedetomidine on Propofol Requirement for Insertion of Laryngeal Mask Airway

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284672
First Posted: November 6, 2014
Last Update Posted: February 29, 2016
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.
Information provided by (Responsible Party):
Jiyoung Yoo, Ajou University School of Medicine
  Purpose
Propofol frequently used as an inducting medication for insertion Laryngeal mask airway(LMA). But propofol alone can be not sufficient for inhibiting upper airway reflex and also result in cardiovascular suppression under enough amount. Dexmedetomidine is a selective alplh2 receptor agonist with analgesic and sedative effects but sparing respiratory function. Therefore propofol combined with dexmedetomidine induction could be more effective in preserve respiration under same condition for LMA insertion than propofol alone. In this study, the investigators investigate the clinical dose of propofol for LMA insertion with premedication of dexmedetomidine, and evaluate the effect of dexmedetomidine.

Condition Intervention Phase
Precedex Effect to Propofol Requirement Drug: Dexmedetomidine Drug: Normal saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: The Effect of Dexmedetomidine on Propofol Requirement for Insertion of Laryngeal Mask Airway

Resource links provided by NLM:


Further study details as provided by Jiyoung Yoo, Ajou University School of Medicine:

Primary Outcome Measures:
  • Fail or success for Laryngeal Mask Airway (LMA) insertion [ Time Frame: During inserting LMA and up to 5 seconds after LMA inserion ]
    Failure for LMA insertion is defined if there is a difficulty for mouth opening or active movement of four limbs or head. Success is smooth LMA insertion without any movement


Enrollment: 39
Study Start Date: November 2014
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: control

After preoxygenation for 3 minutes, normal saline would be injected to patient for 10 minute. First, 1% lidocaine 3 ml were given for reducing injection pain of propofol and the settled amount of propofol was injected during 15 seconds.

After 90 seconds, other anesthesiologist who did'nt know the injected drug tried to insert LMA.

Drug: Normal saline
Experimental: dexmedetomidine

After preoxygenation for 3 minutes, dexmedetomidine would be injected to patient for 10 minute. First, 1% lidocaine 3 ml were given for reducing injection pain of propofol and the settled amount of propofol was injected during 15 seconds.

After 90 seconds, other anesthesiologist who did'nt know the injected drug tried to insert LMA.

Drug: Dexmedetomidine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients for surgery not exceed more than 2 hours requiring general anesthesia

Exclusion Criteria:

  • history of gastroesophageal reflux High grade obesity Predicted diffiicult airway
  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): NCT02284672


Locations
Korea, Republic of
Jiyoung Yoo
Suweon, Kyunggido, Korea, Republic of, 443-380
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Principal Investigator: Ji Young Yoo, MD Ajou University School of Medicine
  More Information

Responsible Party: Jiyoung Yoo, clinical assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02284672     History of Changes
Other Study ID Numbers: AJIRB-MED-CT4-14-296
First Submitted: November 4, 2014
First Posted: November 6, 2014
Last Update Posted: February 29, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Propofol
Dexmedetomidine
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