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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
History of Changes
  Purpose

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.


Condition Intervention
Intravenous Drug Usage
 Device: Remi50 with prime
Device: Remi20 with prime

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Study of Proper Operation of the Syringe Pump Used in Priming of the Syringe

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ajou University School of Medicine:

Primary Outcome Measures:
  • 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


Enrollment: 48
Study Start Date: March 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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,
 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
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
 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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • body weight exceeding 20% of ideal body weight
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477905

Locations
Korea, Republic of
Ajou University School of Medicine
Suwon, Korea, Republic of, 443-721
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Study Director: Jong Yeop Kim, M.D. Ajou University School of Medicine
  More Information

Publications:

Responsible Party: Jong Yeop Kim, Associate professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01477905     History of Changes
Other Study ID Numbers: AJIRB-DEV-DEO-11-005
Study First Received: November 14, 2011
Last Updated: November 22, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Ajou University School of Medicine:
priming
remifentanil
target-controlled infusion

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 19, 2013