Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Intravenous Anesthesia (PIPDIA)

July 27, 2016 updated by: bo xu, Guangzhou General Hospital of Guangzhou Military Command

Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Target-controlled Infusion Intravenous Anesthesia During the Induction

The purpose of this study is to determine pharmacodynamic interactions of propofol and dexmedetomidine,exploring the effect of dexmedetomidine on propofol unconsciousness median effective concentration (EC50).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

64 cases were 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 was started to provide a target effect-site concentration of 1.0ug/ml, and increased by 0.2ug/ml until loss of consciousness when the effect-site concentration and target concentration equilibrium.

Study Type

Interventional

Enrollment (Actual)

64

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
        • 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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Propofol and 0.0ng/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 0.2ug/ml until the patient's consciousness disappears.
Drug: Propofol
Drug: 0.0ng/ml Dexmedetomidine
Dexmedetomidine target plasma concentration is 0.0ng/ml
Experimental: Propofol and 0.4ng/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 0.2ug/ml until the patient's consciousness disappears.
Drug: Propofol
Drug: 0.4ng/ml Dexmedetomidine
Dexmedetomidine target plasma concentration is 0.4ng/ml
Experimental: Propofol and 0.6ng/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 0.2ug/ml until the patient's consciousness disappears.
Drug: Propofol
Drug: 0.6ng/ml Dexmedetomidine
Dexmedetomidine target plasma concentration is 0.6ng/ml
Experimental: Propofol and 0.8ng/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 0.2ug/ml until the patient's consciousness disappears.
Drug: Propofol
Drug: 0.8ng/ml Dexmedetomidine
Dexmedetomidine target plasma concentration is 0.8ng/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The EC50 of propofol for loss of consciousness
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
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.

Sponsor

Guangzhou General Hospital of Guangzhou Military Command

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

January 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pharmacodynamic Interactions

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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