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Completed

NCT Number: NCT02853864

Influence of Gender on Interaction of Propofol and Dexmedetomidine

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.

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Key information

Conditions

Anesthesia Behavior Coitus Sexual Behavior

Age range

20 year–50 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

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.

Who can participate

Healthy volunteers accepted: No

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

0.0 ng/ml Dexmedetomidine

Drug

Dexmedetomidine target plasma concentration is 0.0 ng/ml

0.4 ng/ml Dexmedetomidine

Drug

Dexmedetomidine target plasma concentration is 0.4 ng/ml

0.6 ng/ml Dexmedetomidine

Drug

Dexmedetomidine target plasma concentration is 0.6 ng/ml

0.8 ng/ml Dexmedetomidine

Drug

Dexmedetomidine target plasma concentration is 0.8 ng/ml

Propofol

Drug

The propofol infusion was started to provide an effect-site concentration of 1.0 ug/ml, and increased by 0.2 ug/ml until loss of consciousness

Primary outcomes

  1. 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

  1. The EC95 of propofol for 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 (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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 3, 2016
Registry last updated
Jan 31, 2018

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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