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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:
ClinicalTrials.gov Identifier:
NCT01477905
First Posted: November 23, 2011
Last Update Posted: November 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jong Yeop Kim, Ajou University School of Medicine
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by Jong Yeop Kim, Ajou University School of Medicine:

Primary Outcome Measures:
  • delivered infusates of remifentanil [ Time Frame: 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


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

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 14, 2011
First Posted: November 23, 2011
Last Update Posted: November 23, 2011
Last Verified: November 2011

Keywords provided by Jong Yeop Kim, Ajou University School of Medicine:
priming
remifentanil
target-controlled infusion

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