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

Ajou University School of Medicine

Status: Completed

Conditions: Intravenous Drug Usage

Treatments: Device: Remi20 with prime; Device: Remi50 with prime

Study type: Interventional

Funder types: Other

Identifiers

NCT01477905

AJIRB-DEV-DEO-11-005

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• body weight exceeding 20% of ideal body weight

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Remi50 no prime

Experimental group

Description:

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,

Treatment:

Device: Remi50 with prime

Remi20 no prmie

Experimental group

Description:

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

Treatment:

Device: Remi20 with prime