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Clinical Trials/NCT01477905
NCT01477905CompletedNot Applicable

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

Ajou University School of Medicine2 sites in 1 country48 target enrollmentStarted: March 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
48
Locations
2
Primary Endpoint
delivered infusates of remifentanil

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • body weight exceeding 20% of ideal body weight

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ajou University School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jong Yeop Kim

Associate professor

Ajou University School of Medicine

Study Sites (2)

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