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

NCT01477905 | Completed

• 1 other identifier: AJIRB-DEV-DEO-11-005
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravenous Drug Usage

Keywords

priming; remifentanil; target-controlled infusion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Remi50 no prime

EXPERIMENTAL

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

Remi20 no prmie

EXPERIMENTAL

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

Interventions

Remi50 with prime DEVICE

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

Also known as: remi50 prime

Remi50 no prime

Remi20 with prime DEVICE

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

Also known as: remi20 prime

Remi20 no prmie

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• body weight exceeding 20% of ideal body weight

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University School of Medicine

Suwon, 443-721, South Korea

Location

Related 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. doi: 10.1111/j.1365-2044.1998.53s104.x.

  PMID: 9640119 RESULT

Study Officials

• Jong Yeop Kim, M.D.

  Ajou University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 23, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 23, 2011

Record last verified: 2011-11

Locations

KR (1)