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CompletedNCT02853864Updated Jan 31, 2018

Influence of Gender on Interaction of Propofol and Dexmedetomidine

A Phase 4 interventional study of 0.0 ng/ml Dexmedetomidine and 0.4 ng/ml Dexmedetomidine in Anesthesia, sponsored by Guangzhou General Hospital of Guangzhou Military Command. Completed at 1 site in China. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-01-31.

Sponsored by Guangzhou General Hospital of Guangzhou Military Command · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Anesthesia

Keywords

  • Gender
  • Propofol
  • Dexmedetomidine
  • Interaction
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In context

Lead sponsor

Guangzhou General Hospital of Guangzhou Military Command is the lead sponsor of 46 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Weight:18≦ BMI≦25
  2. Written informed consent from the patient or the relatives of the participating patient.

Exclusion criteria

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Care provider, Investigator)
Enrollment
120 participants (actual)

Study arms

  • Placebo comparator
    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.

    Drug: 0.0 ng/ml Dexmedetomidine · Drug: Propofol

  • Experimental
    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.

    Drug: 0.4 ng/ml Dexmedetomidine · Drug: Propofol

  • Experimental
    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.

    Drug: 0.6 ng/ml Dexmedetomidine · Drug: Propofol

  • Experimental
    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.

    Drug: 0.8 ng/ml Dexmedetomidine · Drug: Propofol

Interventions

  • Drug0.0 ng/ml Dexmedetomidine

    Dexmedetomidine target plasma concentration is 0.0 ng/ml

  • Drug0.4 ng/ml Dexmedetomidine

    Dexmedetomidine target plasma concentration is 0.4 ng/ml

  • Drug0.6 ng/ml Dexmedetomidine

    Dexmedetomidine target plasma concentration is 0.6 ng/ml

  • Drug0.8 ng/ml Dexmedetomidine

    Dexmedetomidine target plasma concentration is 0.8 ng/ml

  • DrugPropofol

    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

06

What researchers measure

Primary outcomes

  1. the effect-site EC50 of propofol on loss of consciousness with different gender

    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.

    Time frame: within 30 min during the induction of anesthesia

Secondary outcomes

  1. The EC95 of propofol for loss of consciousness with different gender

    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.

    Time frame: within 30 min during the induction of anesthesia

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Study locations

1 site
  • Guangzhou Military Region General Hospital, Department of Anesthesiology
    Guangzhou, Guangdong 510010, China
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References and documents

Publications

  • Kodaka M, Johansen JW, Sebel PS. The influence of gender on loss of consciousness with sevoflurane or propofol. Anesth Analg. 2005 Aug;101(2):377-381. doi: 10.1213/01.ANE.0000154534.71371.4F. PubMed 16037147 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02853864
Lead sponsor
Guangzhou General Hospital of Guangzhou Military Command
Responsible party
bo xu (associate chief physician, Guangzhou General Hospital of Guangzhou Military Command) — Principal investigator
First posted
Aug 3, 2016
Start date
Aug 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jan 31, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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