Influence of Gender on Interaction of Propofol and Dexmedetomidine
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- the effect-site EC50 of propofol on loss of consciousness with different gender
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Drug)
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 (Drug)
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 (Drug)
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 (Drug)
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 (Drug)
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 (Drug)
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 (Drug)
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 (Drug)
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)
Investigators
bo xu
associate chief physician
Guangzhou General Hospital of Guangzhou Military Command