Influence of Gender on Interaction of Propofol and Dexmedetomidine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influence of Gender on Interaction of Propofol and Dexmedetomidine

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: 0.0 ng/ml Dexmedetomidine
* Drug: 0.4 ng/ml Dexmedetomidine
* Drug: 0.6 ng/ml Dexmedetomidine
* Drug: 0.8 ng/ml Dexmedetomidine
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Propofol and 0.0 ng/ml Dexmedetomidine<br>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. | Drug: 0.0 ng/ml Dexmedetomidine<br>* Dexmedetomidine target plasma concentration is 0.0 ng/ml<br>Drug: Propofol<br>* 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<br>|
| Experimental: Propofol and 0.4 ng/ml Dexmedetomidine<br>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. | Drug: 0.4 ng/ml Dexmedetomidine<br>* Dexmedetomidine target plasma concentration is 0.4 ng/ml<br>Drug: Propofol<br>* 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<br>|
| Experimental: Propofol and 0.6 ng/ml Dexmedetomidine<br>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. | Drug: 0.6 ng/ml Dexmedetomidine<br>* Dexmedetomidine target plasma concentration is 0.6 ng/ml<br>Drug: Propofol<br>* 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<br>|
| Experimental: Propofol and 0.8 ng/ml Dexmedetomidine<br>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. | Drug: 0.8 ng/ml Dexmedetomidine<br>* Dexmedetomidine target plasma concentration is 0.8 ng/ml<br>Drug: Propofol<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect-site EC50 of propofol on loss of consciousness with different gender | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gender, Propofol, Dexmedetomidine, Interaction