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Clinical Trials/NCT02853864
NCT02853864
Completed
Phase 4

Influence of Gender on Interaction of Propofol and Dexmedetomidine

Guangzhou General Hospital of Guangzhou Military Command1 site in 1 country120 target enrollmentAugust 2016

Overview

Phase
Phase 4
Intervention
0.0 ng/ml Dexmedetomidine
Conditions
Anesthesia
Sponsor
Guangzhou General Hospital of Guangzhou Military Command
Enrollment
120
Locations
1
Primary Endpoint
the effect-site EC50 of propofol on loss of consciousness with different gender
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Guangzhou General Hospital of Guangzhou Military Command
Responsible Party
Principal Investigator
Principal Investigator

bo xu

associate chief physician

Guangzhou General Hospital of Guangzhou Military Command

Eligibility Criteria

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.

Arms & Interventions

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.

Intervention: 0.0 ng/ml Dexmedetomidine

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.

Intervention: Propofol

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.

Intervention: 0.4 ng/ml Dexmedetomidine

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.

Intervention: Propofol

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.

Intervention: 0.6 ng/ml Dexmedetomidine

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.

Intervention: Propofol

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.

Intervention: 0.8 ng/ml Dexmedetomidine

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.

Intervention: Propofol

Outcomes

Primary Outcomes

the effect-site EC50 of propofol on loss of consciousness with different gender

Time Frame: 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 Outcomes

  • The EC95 of propofol for loss of consciousness with different gender(within 30 min during the induction of anesthesia)

Study Sites (1)

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