Dexmedetomidine for Laryngeal Mask Airway Insertion

April 20, 2014 updated by: Jong Yeop Kim, Ajou University School of Medicine

Optimal Dose of Dexmedetomidine for Laryngeal Mask Airway Insertion During Propofol Induction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Suwon, Korea, Republic of, 443-721
        • Ajou University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • precedex
Drug: propofol
Propofol 2.0 mg/kg was administrated
Other Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Investigators

  • Study Director: Jong Yeop Kim, MD, Ajou University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 9, 2013

First Posted (Estimate)

May 13, 2013

Study Record Updates

Last Update Posted (Estimate)

April 22, 2014

Last Update Submitted That Met QC Criteria

April 20, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-CT4-13-045

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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