Influence of Gender on Interaction of Propofol and Dexmedetomidine

Guangzhou General Hospital of Guangzhou Military Command

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: 0.0 ng/ml Dexmedetomidine; Drug: 0.8 ng/ml Dexmedetomidine; Drug: Propofol; Drug: 0.4 ng/ml Dexmedetomidine; Drug: 0.6 ng/ml Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02853864

Intravenous anesthesia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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120 participants in 4 patient groups, including a placebo group

Propofol and 0.0 ng/ml Dexmedetomidine

Placebo Comparator group

Description:

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.

Treatment:

Drug: Propofol

Drug: 0.0 ng/ml Dexmedetomidine

Propofol and 0.4 ng/ml Dexmedetomidine

Experimental group

Description:

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.

Treatment:

Drug: Propofol

Drug: 0.4 ng/ml Dexmedetomidine

Propofol and 0.6 ng/ml Dexmedetomidine

Experimental group

Description:

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.

Treatment:

Drug: Propofol

Drug: 0.6 ng/ml Dexmedetomidine

Propofol and 0.8 ng/ml Dexmedetomidine

Experimental group

Description:

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.

Treatment:

Drug: 0.8 ng/ml Dexmedetomidine

Drug: Propofol