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

Study of Proper Operation of the Syringe Pump Used in Priming of the Syringe

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01477905

Enrollment

Registered

2011-11-23

Start date

2011-03-31

Completion date

2011-04-30

Last updated

2011-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intravenous Drug Usage

Keywords

priming, remifentanil, target-controlled infusion

Brief summary

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

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.

Interventions

DEVICERemi50 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

DEVICERemi20 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
delivered infusates of remifentanil	base line from 30 min of TCI was maintained	For targetting an effect-site concentration (Ceff) of 4.0 ng/ml, were randomly performed using 50 μg/ml (Remi50) or 20 μg/ml (Remi20) of remifentanil, and with or without PRIMING, TCI data files, including predicted plasma (Cp-proper), and effect-site (Ceff-proper) concentrations were saved

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026