Influence of Gender on Interaction of Propofol and Dexmedetomidine

Sponsor

Guangzhou General Hospital of Guangzhou Military Command (Other)

Overall Status

Completed

CT.gov ID

NCT02853864

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

29.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	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	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Influence of Gender on Interaction of Propofol and Dexmedetomidine

Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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.	Drug: 0.0 ng/ml Dexmedetomidine Dexmedetomidine target plasma concentration is 0.0 ng/ml Drug: Propofol 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.	Drug: 0.4 ng/ml Dexmedetomidine Dexmedetomidine target plasma concentration is 0.4 ng/ml Drug: Propofol 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 0.6 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.	Drug: 0.6 ng/ml Dexmedetomidine Dexmedetomidine target plasma concentration is 0.6 ng/ml Drug: Propofol 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 0.8 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.	Drug: 0.8 ng/ml Dexmedetomidine Dexmedetomidine target plasma concentration is 0.8 ng/ml Drug: Propofol 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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.