- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02853864
Influence of Gender on Interaction of Propofol and Dexmedetomidine
January 30, 2018 updated by: bo xu, Guangzhou General Hospital of Guangzhou Military Command
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
Status
Completed
Conditions
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:
- Weight:18≦ BMI≦25
- Written informed consent from the patient or the relatives of the participating patient.
Exclusion Criteria:
- A previous history of intolerance to the study drug or related compounds and additives.
- 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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Propofol
- Dexmedetomidine
Other Study ID Numbers
- Intravenous anesthesia
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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