Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Intravenous Anesthesia

NCT02777619 | Completed Phase 4

• 1 other identifier: Pharmacodynamic Interactions
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pharmacodynamic Interaction

Keywords

Pharmacodynamic; Dexmedetomidine; Propofol; Target-controlled Infusion Intravenous Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The EC95 of propofol for loss of consciousness

  within 30 min during the induction of anesthesia

Study Arms (4)

Propofol and 0.0ng/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 0.2ug/ml until the patient's consciousness disappears.

Drug: 0.0ng/ml Dexmedetomidine; Drug: Propofol

Propofol and 0.4ng/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 0.2ug/ml until the patient's consciousness disappears.

Drug: 0.4ng/ml Dexmedetomidine; Drug: Propofol

Propofol and 0.6ng/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 0.2ug/ml until the patient's consciousness disappears.

Drug: 0.6ng/ml Dexmedetomidine; Drug: Propofol

Propofol and 0.8ng/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 0.2ug/ml until the patient's consciousness disappears.

Drug: 0.8ng/ml Dexmedetomidine; Drug: Propofol

Interventions

0.0ng/ml Dexmedetomidine DRUG

Dexmedetomidine target plasma concentration is 0.0ng/ml

Propofol and 0.0ng/ml Dexmedetomidine

0.4ng/ml Dexmedetomidine DRUG

Dexmedetomidine target plasma concentration is 0.4ng/ml

Propofol and 0.4ng/ml Dexmedetomidine

0.6ng/ml Dexmedetomidine DRUG

Dexmedetomidine target plasma concentration is 0.6ng/ml

Propofol and 0.6ng/ml Dexmedetomidine

0.8ng/ml Dexmedetomidine DRUG

Dexmedetomidine target plasma concentration is 0.8ng/ml

Propofol and 0.8ng/ml Dexmedetomidine

Propofol DRUG

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• 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 (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. eCollection 2013.

  PMID: 23519436 BACKGROUND

• 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.

  PMID: 26068206 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Propofol

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 19, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 28, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)