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Impact of Priming the Infusion System on the Performance of Target-controlled Infusion of Remifentanil

NCT ID: NCT01477905

Last Updated: 2011-11-23

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

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-04-30

Brief Summary

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The investigators attempted to determine an adequate priming volume for our infusion system, and investigated the extent of a possible delay of the drug effect, that would result from mechanical defects of the infusion system, with or without priming the infusion system, using direct gravimetrical measurements of virtual infusate amounts during target controlled infusion of 2 remifentanil diluents.

Detailed Description

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Priming the infusion system (PRIMING) was performed using an evacuation of 2.0 ml to the atmosphere prior to Target-controlled Infusion (TCI). Forty eight TCI, using 50 μg/ml or 20 μg/ml of remifentanil diluents, were performed targeting 4.0 ng/ml of effect site concentration (Ceff), with or without PRIMING. Using simulations, the gravimetrical measurements of the delivered infusates reproduced actual predicted concentrations.

Conditions

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Intravenous Drug Usage

Keywords

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priming remifentanil target-controlled infusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Remi50 no prime

For using experimental target control infusion device (TCIs), targeting an effect-site concentration (Ceff) of 4.0 ng/ml, were randomly performed using 50 μg/ml (Remi50) of remifentanil, and without PRIMING,

Group Type EXPERIMENTAL

Remi50 with prime

Intervention Type DEVICE

for using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was performed using 50 μg/ml (Remi50) of remifentanil, with PRIMING

Remi20 no prmie

For using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was 20 μg/ml (Remi20) of remifentanil, and without PRIMING

Group Type EXPERIMENTAL

Remi20 with prime

Intervention Type DEVICE

For using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was 20 μg/ml (Remi20) of remifentanil, and with PRIMING

Interventions

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Remi50 with prime

for using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was performed using 50 μg/ml (Remi50) of remifentanil, with PRIMING

Intervention Type DEVICE

Remi20 with prime

For using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was 20 μg/ml (Remi20) of remifentanil, and with PRIMING

Intervention Type DEVICE

Other Intervention Names

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remi50 prime remi20 prime

Eligibility Criteria

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Inclusion Criteria

* electric medical records of the patients who had undergone general anaesthesia

Exclusion Criteria

* body weight exceeding 20% of ideal body weight
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jong Yeop Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong Yeop Kim, M.D.

Role: STUDY_DIRECTOR

Ajou University School of Medicine

Locations

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Ajou University School of Medicine

Suwon, , South Korea

Site Status

Countries

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South Korea

References

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Swinhoe CF, Peacock JE, Glen JB, Reilly CS. Evaluation of the predictive performance of a 'Diprifusor' TCI system. Anaesthesia. 1998 Apr;53 Suppl 1:61-7. doi: 10.1111/j.1365-2044.1998.53s104.x.

Reference Type RESULT
PMID: 9640119 (View on PubMed)

Other Identifiers

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AJIRB-DEV-DEO-11-005

Identifier Type: -

Identifier Source: org_study_id