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Influence of Gender on Interaction of Propofol and Dexmedetomidine

G

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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