Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Intravenous Anesthesia

NCT ID: NCT02777619

Last Updated: 2016-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Pharmacodynamic Interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Group Type PLACEBO_COMPARATOR

0.0ng/ml Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine target plasma concentration is 0.0ng/ml

Propofol

Intervention Type DRUG

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

Group Type EXPERIMENTAL

0.4ng/ml Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine target plasma concentration is 0.4ng/ml

Propofol

Intervention Type DRUG

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

Group Type EXPERIMENTAL

0.6ng/ml Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine target plasma concentration is 0.6ng/ml

Propofol

Intervention Type DRUG

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

Group Type EXPERIMENTAL

0.8ng/ml Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine target plasma concentration is 0.8ng/ml

Propofol

Intervention Type DRUG

Interventions

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0.0ng/ml Dexmedetomidine

Dexmedetomidine target plasma concentration is 0.0ng/ml

Intervention Type DRUG

0.4ng/ml Dexmedetomidine

Dexmedetomidine target plasma concentration is 0.4ng/ml

Intervention Type DRUG

0.6ng/ml Dexmedetomidine

Dexmedetomidine target plasma concentration is 0.6ng/ml

Intervention Type DRUG

0.8ng/ml Dexmedetomidine

Dexmedetomidine target plasma concentration is 0.8ng/ml

Intervention Type DRUG

Propofol

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangzhou General Hospital of Guangzhou Military Command

OTHER

Sponsor Role lead

Responsible Party

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bo xu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 23519436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26068206 (View on PubMed)

Other Identifiers

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Pharmacodynamic Interactions

Identifier Type: -

Identifier Source: org_study_id

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