Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jong Yeop Kim, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01477905
First received: November 14, 2011
Last updated: November 22, 2011
Last verified: November 2011

November 14, 2011
November 22, 2011
March 2011
April 2011   (final data collection date for primary outcome measure)
delivered infusates of remifentanil [ Time Frame: base line from 30 min of TCI was maintained ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01477905 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Intravenous Drug Usage
  • 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
    Other Name: remi50 prime
  • 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
    Other Name: remi20 prime
  • Experimental: 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,
    Intervention: Device: Remi50 with prime
  • Experimental: 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
    Intervention: Device: Remi20 with prime
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • body weight exceeding 20% of ideal body weight
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01477905
AJIRB-DEV-DEO-11-005
No
Jong Yeop Kim, Ajou University School of Medicine
Ajou University School of Medicine
Not Provided
Study Director: Jong Yeop Kim, M.D. Ajou University School of Medicine
Ajou University School of Medicine
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP