The Effects of Different Doses of Dexmedetomidine on Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index: a Double-blinded, Placebo-controlled Trial

November 6, 2016 updated by: General Hospital of Ningxia Medical University

The Effects of Different Dexmedetomidine on the Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index

The purpose of this study is to evaluate the effects of different dexmedetomidine on the propofol requirement for loss of consciousness undergoing bispectral index.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It has been shown that dexmedetomidine was an efficacious and safe adjuvant in general anaesthesia. Administration of dexmedetomidine during the preoperative period has been demonstrated to reduce the requirement of opioid analgesics and other sedative and hypnotic drugs.Therefore, the study is designed to measure the effect of intravenous dexmedetomidine premedication on the propofol dose requirement and bispectral index at loss of consciousness.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA physical status I-II
  • Aged 18-65 years
  • Body Mass Index 18.0～24.5 kg/m2
  • Without hearing impairment

Exclusion Criteria:

  • Bradycardia
  • Atrioventricular block
  • Neurologic disorder and recent use of psychoactive medication
  • Allergic to the drugs

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Group control
24 eligible patients are received equal volumes of saline intravenously for 10 minutes
Other: normal saline
receive equal volume of normal saline
ACTIVE_COMPARATOR: Group dexmedetomidine 0.5 µg/kg
24 eligible patients are received dexmedetomidine 0.5 µg/kg intravenously for 10 minutes
Drug: dexmedetomidine 0.5 µg/kg
receive dexmedetomidine 0.5 µg/kg
ACTIVE_COMPARATOR: Group dexmedetomidine 1.0 µg/kg
25 eligible patients are received dexmedetomidine 1.0 µg/kg intravenously for 10 minutes
Drug: dexmedetomidine 1.0 µg/kg
receive dexmedetomidine 1.0 µg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The propofol requirement for pretreatment of dexmedetomidine by micro-pump until loss of consciousness
Time Frame: To infuse dexmedetomidine and saline completely ten minutes after
To infuse dexmedetomidine and saline completely ten minutes after

Secondary Outcome Measures

Outcome Measure
Time Frame
The bispectral index values when patients loss of consciousness
Time Frame: To infuse dexmedetomidine and saline completely ten minutes after
To infuse dexmedetomidine and saline completely ten minutes after

Collaborators and Investigators

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

Sponsor

General Hospital of Ningxia Medical University

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

June 1, 2016

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

May 25, 2016

First Posted (ESTIMATE)

May 26, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 6, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHX00123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

safety

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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