Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Intravenous Anesthesia

Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Target-controlled Infusion Intravenous Anesthesia During the Induction

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02777619

Acronym

PIPDIA

Enrollment

Registered

2016-05-19

Start date

2016-01-31

Completion date

2016-07-31

Last updated

2016-07-28

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

Conditions

Pharmacodynamic Interaction

Keywords

Pharmacodynamic, Dexmedetomidine, Propofol, Target-controlled Infusion Intravenous Anesthesia

Brief summary

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).

Detailed 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.

Interventions

DRUG0.0ng/ml Dexmedetomidine

Dexmedetomidine target plasma concentration is 0.0ng/ml

DRUG0.4ng/ml Dexmedetomidine

Dexmedetomidine target plasma concentration is 0.4ng/ml

DRUG0.6ng/ml Dexmedetomidine

Dexmedetomidine target plasma concentration is 0.6ng/ml

DRUG0.8ng/ml Dexmedetomidine

Dexmedetomidine target plasma concentration is 0.8ng/ml

DRUGPropofol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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 EC50 of propofol for loss of consciousness	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	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