Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Intravenous Anesthesia (PIPDIA)

Guangzhou General Hospital of Guangzhou Military Command

Status and phase: Completed; Phase 4

Conditions: Pharmacodynamic Interaction

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02777619

Pharmacodynamic Interactions

Details and patient eligibility

About

The purpose of this study is to determine pharmacodynamic interactions of propofol and dexmedetomidine,exploring the effect of dexmedetomidine on propofol unconsciousness median effective concentration (EC50).

Full description

64 cases were 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 was started to provide a target effect-site concentration of 1.0ug/ml, and increased by 0.2ug/ml until loss of consciousness when the effect-site concentration and target concentration equilibrium.

Enrollment: 64 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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: Parallel Assignment

Masking: None (Open label)

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64 participants in 4 patient groups, including a placebo group

Propofol and 0.0ng/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 0.2ug/ml until the patient's consciousness disappears.

Treatment:

Drug: 0.0ng/ml Dexmedetomidine

Drug: Propofol

Propofol and 0.4ng/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 0.2ug/ml until the patient's consciousness disappears.

Treatment:

Drug: 0.4ng/ml Dexmedetomidine

Drug: Propofol

Propofol and 0.6ng/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 0.2ug/ml until the patient's consciousness disappears.

Treatment:

Drug: Propofol

Drug: 0.6ng/ml Dexmedetomidine

Propofol and 0.8ng/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 0.2ug/ml until the patient's consciousness disappears.

Treatment:

Drug: 0.8ng/ml Dexmedetomidine

Drug: Propofol