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Completed

NCT Number: NCT02777619

Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Intravenous Anesthesia

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).

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Key information

Conditions

Pharmacodynamic Interaction

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, 510010, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.0ng/ml Dexmedetomidine

Drug

Dexmedetomidine target plasma concentration is 0.0ng/ml

0.4ng/ml Dexmedetomidine

Drug

Dexmedetomidine target plasma concentration is 0.4ng/ml

0.6ng/ml Dexmedetomidine

Drug

Dexmedetomidine target plasma concentration is 0.6ng/ml

0.8ng/ml Dexmedetomidine

Drug

Dexmedetomidine target plasma concentration is 0.8ng/ml

Propofol

Drug

Primary outcomes

  1. The EC50 of propofol for loss of consciousness

    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

  1. The EC95 of propofol for loss of consciousness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Guangzhou General Hospital of Guangzhou Military Command

Other

Registry information

Official study title

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

Acronym: PIPDIA

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 19, 2016
Registry last updated
Jul 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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