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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Chul-Woo Jung, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01003028
First Posted: October 28, 2009
Last Update Posted: May 28, 2015
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):
Chul-Woo Jung, Seoul National University Hospital
October 23, 2009
October 28, 2009
May 28, 2015
November 2015
December 2015   (Final data collection date for primary outcome measure)
hypotension more than 25% from baseline [ Time Frame: during remifentanil loading ]
Same as current
Complete list of historical versions of study NCT01003028 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
 
Unknown status
160
December 2015
December 2015   (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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01003028
CW Jung_TCI_Remi_Cpmax
Yes
Not Provided
Not Provided
Chul-Woo Jung, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
May 2015

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