Influence of Gender on Interaction of Propofol and Dexmedetomidine

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02853864

Enrollment

120

Registered

2016-08-03

Start date

2016-08-31

Completion date

2016-12-31

Last updated

2018-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Gender, Propofol, Dexmedetomidine, Interaction

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.

Interventions

DRUG0.0 ng/ml Dexmedetomidine

Dexmedetomidine target plasma concentration is 0.0 ng/ml

DRUG0.4 ng/ml Dexmedetomidine

Dexmedetomidine target plasma concentration is 0.4 ng/ml

DRUG0.6 ng/ml Dexmedetomidine

Dexmedetomidine target plasma concentration is 0.6 ng/ml

DRUG0.8 ng/ml Dexmedetomidine

Dexmedetomidine target plasma concentration is 0.8 ng/ml

DRUGPropofol

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026