Influence of Gender on Interaction of Propofol and Dexmedetomidine

NCT02853864 | Completed Phase 4

• 1 other identifier: Intravenous anesthesia
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia

Keywords

Gender; Propofol; Dexmedetomidine; Interaction

Outcome Measures

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.

  within 30 min during the induction of anesthesia

Secondary Outcomes (1)

• The EC95 of propofol for loss of consciousness with different gender

  within 30 min during the induction of anesthesia

Study Arms (4)

Propofol and 0.0 ng/ml Dexmedetomidine

PLACEBO COMPARATOR

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

Propofol and 0.4 ng/ml Dexmedetomidine

EXPERIMENTAL

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

Propofol and 0.6 ng/ml Dexmedetomidine

EXPERIMENTAL

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

Propofol and 0.8 ng/ml Dexmedetomidine

EXPERIMENTAL

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

0.0 ng/ml Dexmedetomidine DRUG

Dexmedetomidine target plasma concentration is 0.0 ng/ml

Propofol and 0.0 ng/ml Dexmedetomidine

0.4 ng/ml Dexmedetomidine DRUG

Dexmedetomidine target plasma concentration is 0.4 ng/ml

Propofol and 0.4 ng/ml Dexmedetomidine

0.6 ng/ml Dexmedetomidine DRUG

Dexmedetomidine target plasma concentration is 0.6 ng/ml

Propofol and 0.6 ng/ml Dexmedetomidine

0.8 ng/ml Dexmedetomidine DRUG

Dexmedetomidine target plasma concentration is 0.8 ng/ml

Propofol and 0.8 ng/ml Dexmedetomidine

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

Propofol and 0.0 ng/ml Dexmedetomidine; Propofol and 0.4 ng/ml Dexmedetomidine; Propofol and 0.6 ng/ml Dexmedetomidine; Propofol and 0.8 ng/ml Dexmedetomidine

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• A previous history of intolerance to the study drug or related compounds and additives.
• Existing significant haematological, endocrine, metabolic or gastrointestinal disease.

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead

Study Sites (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, 510010, China

Location

Related Publications (1)

• 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.

  PMID: 16037147 BACKGROUND

MeSH Terms

Conditions

Coitus

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: August 3, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 31, 2018

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)