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

February 26, 2016 updated by: Jiyoung Yoo, Ajou University School of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

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

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

15 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During inserting LMA and up to 5 seconds after LMA inserion

Collaborators and Investigators

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

Sponsor

Ajou University School of Medicine

Investigators

  • Principal Investigator: Ji Young Yoo, md, Ajou University School of Medicine

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

November 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 4, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Estimate)

February 29, 2016

Last Update Submitted That Met QC Criteria

February 26, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-CT4-14-296

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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