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

Not Applicable

Completed

• Conditions: Intravenous Drug Usage
• Interventions: Device: Remi50 with prime; Device: Remi20 with prime

• Registration Number: NCT01477905
• Lead Sponsor: Ajou University School of Medicine

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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-11
• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-22
• Last Update Submitted: 2011-11-22
• Study First Posted: 2011-11-23
• Last Update Posted: 2011-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

Exclusion Criteria

• body weight exceeding 20% of ideal body weight

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remi50 no prime	Remi50 with 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,
Remi20 no prmie	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 without PRIMING

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ajou University School of Medicine; 🇰🇷 Suwon, Korea, Republic of