Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Intravenous Anesthesia

Pharmacodynamic Interaction Clinical Trial

— PIPDIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777619
• Other study ID #: Pharmacodynamic Interactions
• Status: Completed
• Phase: Phase 4
• First received: May 11, 2016
• Last updated: July 27, 2016
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: May 2016
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharmacodynamic Interaction

Intervention

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

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 (2)

Chen Z, Shao DH, Hang LH. Effects of dexmedetomidine on performance of bispectral index as an indicator of loss of consciousness during propofol administration. Swiss Med Wkly. 2013 Mar 14;143:w13762. doi: 10.4414/smw.2013.13762. — View Citation

Hannivoort LN, Eleveld DJ, Proost JH, Reyntjens KM, Absalom AR, Vereecke HE, Struys MM. Development of an Optimized Pharmacokinetic Model of Dexmedetomidine Using Target-controlled Infusion in Healthy Volunteers. Anesthesiology. 2015 Aug;123(2):357-67. doi: 10.1097/ALN.0000000000000740. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The EC50 of propofol for loss of consciousness	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	No
Secondary	The EC95 of propofol for loss of consciousness	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	No