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Reduction of Remifentanil-related Complications by Limiting Maximum Plasma Concentration During Target-controlled Infusion

This study is not yet open for participant recruitment.
Verified May 2012 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Chul-Woo Jung, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01003028
First received: October 23, 2009
Last updated: May 1, 2012
Last verified: May 2012
History of Changes

October 23, 2009
May 1, 2012
November 2012
December 2013   (final data collection date for primary outcome measure)
hypotension more than 25% from baseline [ Time Frame: during remifentanil loading ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01003028 on ClinicalTrials.gov Archive Site
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Reduction of Remifentanil-related Complications by Limiting Maximum Plasma Concentration During Target-controlled Infusion
Not Provided

This study is intended to evaluate the effect of decreasing the maximum plasma concentration target of remifentanil of the Target Controlled Infusion system on the the incidence of major and minor side-effects.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Anesthesia
  • Drug: Remifentanil (Limited) - Target Controlled Infusion system
    Limit max plasma concentration to 9.8 ng/ml
  • Drug: Remifentanil (Control) - Target Controlled Infusion system
    Use 20 ng/ml as max plasma concentration
  • Experimental: Limited
    Limit the maximum plasma concentration target to 9.8 ng/ml
    Intervention: Drug: Remifentanil (Limited) - Target Controlled Infusion system
  • Active Comparator: Control
    Use 20 ng/ml as max plasma concentration
    Intervention: Drug: Remifentanil (Control) - Target Controlled Infusion system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
160
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-70 year old
  • ASA class 1-3 scheduled for elective surgery

Exclusion Criteria:

  • history of neurologic or mental disorder
  • uncontrolled pulmonary or cardiovascular disease
  • history of adverse reactions to opioids
  • history of drug abuse
Both
18 Years to 70 Years
No
Contact: Ho Geol Ryu, MD, PhD 82-17-259-9173 hogeol@gmail.com
Korea, Republic of
 
NCT01003028
CW Jung_TCI_Remi_Cpmax
Yes
Chul-Woo Jung, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
May 2012

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