Influence of Gender on Interaction of Propofol and Dexmedetomidine

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: 0.0 ng/ml Dexmedetomidine; Drug: 0.8 ng/ml Dexmedetomidine; Drug: 0.4 ng/ml Dexmedetomidine; Drug: 0.6 ng/ml Dexmedetomidine; Drug: Propofol

• Registration Number: NCT02853864
• Lead Sponsor: Guangzhou General Hospital of Guangzhou Military Command

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-07-27
• Study Start: 2016-08
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-03
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Propofol and 0.0 ng/ml Dexmedetomidine	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.
Propofol and 0.8 ng/ml Dexmedetomidine	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.
Propofol and 0.4 ng/ml Dexmedetomidine	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.
Propofol and 0.6 ng/ml Dexmedetomidine	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.
Propofol and 0.0 ng/ml Dexmedetomidine	Propofol	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.
Propofol and 0.4 ng/ml Dexmedetomidine	Propofol	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.
Propofol and 0.6 ng/ml Dexmedetomidine	Propofol	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.
Propofol and 0.8 ng/ml Dexmedetomidine	Propofol	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.

Primary Outcome Measures

Name	Time	Method
the effect-site EC50 of propofol on loss of consciousness with different gender	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.

Secondary Outcome Measures

Name	Time	Method
The EC95 of propofol for loss of consciousness with different gender	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.

Trial Locations

Locations (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology; 🇨🇳 Guangzhou, Guangdong, China