Influence of Gender on Interaction of Propofol and Dexmedetomidine

The purpose of this study is to determine the effect of gender on pharmacodynamic interaction of propofol and dexmedetomidine, exploring the effect of gender on propofol unconsciousness median effective concentration with different dose dexmedetomidine.

Study Overview

Detailed Description

60 cases male patients were randomly divided into four groups,and 60 female patients were also randomly divided into four groups.In each group, dexmedetomidine target plasma concentration are 0,0.4,0.6,0.8 ng/ml. Dexmedetomidine administered 15 min before target controlled infusion of propofol. The propofol infusion is started to provide a target effect-site concentration of 1.0 ug/ml, and increased by 0.2 ug/ml until loss of consciousness when the effect-site concentration and target concentration are equilibrium.

Study Type

Interventional

Enrollment (Actual)

120

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

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

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Weight:18≦ BMI≦25
  2. Written informed consent from the patient or the relatives of the participating patient.

Exclusion Criteria:

  1. A previous history of intolerance to the study drug or related compounds and additives.
  2. Existing significant haematological, endocrine, metabolic or gastrointestinal disease.

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Propofol and 0.0 ng/ml Dexmedetomidine
Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.0ng/ml administered for 15min, and increased by 0.2 ug/ml until the patient's consciousness disappears.
Dexmedetomidine target plasma concentration is 0.0 ng/ml
The propofol infusion was started to provide an effect-site concentration of 1.0 ug/ml, and increased by 0.2 ug/ml until loss of consciousness
Experimental: Propofol and 0.4 ng/ml Dexmedetomidine
Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.4ng/ml administered for 15min, and increased by 0.2 ug/ml until the patient's consciousness disappears.
The propofol infusion was started to provide an effect-site concentration of 1.0 ug/ml, and increased by 0.2 ug/ml until loss of consciousness
Dexmedetomidine target plasma concentration is 0.4 ng/ml
Experimental: Propofol and 0.6 ng/ml Dexmedetomidine
Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.6ng/ml administered for 15min, and increased by 0.2 ug/ml until the patient's consciousness disappears.
The propofol infusion was started to provide an effect-site concentration of 1.0 ug/ml, and increased by 0.2 ug/ml until loss of consciousness
Dexmedetomidine target plasma concentration is 0.6 ng/ml
Experimental: Propofol and 0.8 ng/ml Dexmedetomidine
Propofol infusion was started to provide an effect-site concentration of 1.0ug/ml after Dexmedetomidine which target plasma concentration is 0.8ng/ml administered for 15min, and increased by 0.2 ug/ml until the patient's consciousness disappears.
The propofol infusion was started to provide an effect-site concentration of 1.0 ug/ml, and increased by 0.2 ug/ml until loss of consciousness
Dexmedetomidine target plasma concentration is 0.8 ng/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effect-site EC50 of propofol on loss of consciousness with different gender
Time Frame: within 30 min during the induction of anesthesia
The aim of the investigators study is to define the optimum target concentration (EC50) of propofol for loss of consciousness with different dexmedetomidine target plasm concentration.
within 30 min during the induction of anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The EC95 of propofol for loss of consciousness with different gender
Time Frame: within 30 min during the induction of anesthesia
The aim of the investigators study is to define the optimum target concentration (EC95) of propofol for loss of consciousness with different dexmedetomidine target plasm concentration.
within 30 min during the induction of anesthesia

Collaborators and Investigators

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

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.

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

August 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

December 1, 2016

More Information

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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