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

Intravenous Drug Usage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477905
• Other study ID #: AJIRB-DEV-DEO-11-005
• Status: Completed
• Phase: N/A
• First received: November 14, 2011
• Last updated: November 22, 2011
• Start date: March 2011
• Est. completion date: April 2011

Study information

• Verified date: November 2011
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intravenous Drug Usage

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Ajou University School of Medicine	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delivered infusates of remifentanil	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	base line from 30 min of TCI was maintained	Yes