Determine the ED50 of Dexmedetomidine to Facilitate LMA Insertion During Anaesthesia Induction

March 11, 2015 updated by: bo xu, Guangzhou General Hospital of Guangzhou Military Command

To Determine the Median Effective Dose (ED50) of Dexmedetomidine to Facilitate LMA Insertion During Anaesthesia Induction With Propofol 2.0 mg/kg

Dexmedetomidine can be used as a co-induction agent to facilitate laryngeal mask airway (LMA) insertion with minimal effect on respiratory function. The purpose of the study was to determine the median effective dose (ED50) of dexmedetomidine to facilitate LMA insertion during anaesthesia induction with propofol 2.0 mg/kg.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Dexmedetomidine is a highly selective α2 receptor agonist, which produces sedative, anxiolytic and analgesic effects without causing clinically significant respiratory depression. Dexmedetomidine also reduces the propofol requirement for sedation and anaesthesia induction. Therefore, dexmedetomidine may be a useful co-induction agent to facilitate LMA insertion with minimal effects on respiratory function. A recent study showed that dexmedetomidine administration prior to propofol induction provided similar conditions for successful LMA insertion, as does fentanyl without respiratory depression. The purpose of this study was to determine the median effective dose (ED50) of dexmedetomidine required for successful LMA insertion during induction with propofol of 2 mg/kg .

Study Type

Interventional

Enrollment (Anticipated)

30

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

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510010
        • Recruiting
        • Guangzhou Military Region General Hospital, Department of Anesthesiology
        • Contact:

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. ASA Ⅰ ~ Ⅱ women undergoing Laparoscopic surgery.
  2. Written informed consent from the patient or the relatives of the participating patient.
  3. BMI:18.5～25

Exclusion Criteria:

  1. Mental illness can not match
  2. epidural anesthesia contraindicated
  3. People who have Slow-type arrhythmias
  4. Chronic renal failure
  5. Alcohol or drug abuse
  6. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine
After an injection of pre-determined bolus dose of dexmedetomidine over 10 min, anaesthesia was induced with propofol 2.0 mg/kg. The modified Dixon's up-and-down method was used to determine the bolus dose of dexmedetomidine, starting from 1.0μg/kg (step size; 0.1μg/kg).
Drug: Propofol
Drug: Dexmedetomidine
The modified Dixon's up-and-down method was used to determine the bolus dose of dexmedetomidine, starting from 1.0μg/kg (step size; 0.1μg/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The assessment of sedation (determine the effect-site dose of dexmedetomidine blunting cardiovascular responses to the insertion of the laryngeal mask airway at the same level of sedation)
Time Frame: 5min after the end of the infusion
The aim of this study was to determine the effect-site dose of dexmedetomidine blunting cardiovascular responses to the insertion of the laryngeal mask airway at the same level of sedation.
5min after the end of the infusion

Collaborators and Investigators

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

Sponsor

Guangzhou General Hospital of Guangzhou Military Command

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 (Anticipated)

April 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

March 6, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (Estimate)

March 12, 2015

Study Record Updates

Last Update Posted (Estimate)

March 12, 2015

Last Update Submitted That Met QC Criteria

March 11, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMA insertion

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.

Clinical Trials on Anesthesia

Clinical Trials on Propofol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe