Influence of Gender on Interaction of Propofol and Dexmedetomidine

Anesthesia Clinical Trial

Official title:

Influence of Gender on Interaction of Propofol and Dexmedetomidine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02853864
• Other study ID #: Intravenous anesthesia
• Status: Completed
• Phase: Phase 4
• First received: July 27, 2016
• Last updated: January 30, 2018
• Start date: August 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• 0.0 ng/ml Dexmedetomidine
Dexmedetomidine target plasma concentration is 0.0 ng/ml
• 0.4 ng/ml Dexmedetomidine
Dexmedetomidine target plasma concentration is 0.4 ng/ml
• 0.6 ng/ml Dexmedetomidine
Dexmedetomidine target plasma concentration is 0.6 ng/ml
• 0.8 ng/ml Dexmedetomidine
Dexmedetomidine target plasma concentration is 0.8 ng/ml
• Propofol
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

Locations

Country	Name	City	State
China	Guangzhou Military Region General Hospital, Department of Anesthesiology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

References & 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):377-81, table of contents. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	within 30 min during the induction of anesthesia