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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
  Purpose
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.

Condition Intervention Phase
Anesthesia Drug: Remifentanil (Limited) - Target Controlled Infusion system Drug: Remifentanil (Control) - Target Controlled Infusion system Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Chul-Woo Jung, Seoul National University Hospital:

Primary Outcome Measures:
  • hypotension more than 25% from baseline [ Time Frame: during remifentanil loading ]

Estimated Enrollment: 160
Study Start Date: November 2015
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Limited
Limit the maximum plasma concentration target to 9.8 ng/ml
Drug: Remifentanil (Limited) - Target Controlled Infusion system
Limit max plasma concentration to 9.8 ng/ml
Active Comparator: Control
Use 20 ng/ml as max plasma concentration
Drug: Remifentanil (Control) - Target Controlled Infusion system
Use 20 ng/ml as max plasma concentration

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT01003028


Contacts
Contact: Ho Geol Ryu, MD, PhD 82-17-259-9173 hogeol@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Chul-Woo Jung, MD PhD       spss@dreamwiz.com   
Principal Investigator: Chul Woo Jung, MD PhD         
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Responsible Party: Chul-Woo Jung, Assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01003028     History of Changes
Other Study ID Numbers: CW Jung_TCI_Remi_Cpmax
First Submitted: October 23, 2009
First Posted: October 28, 2009
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Chul-Woo Jung, Seoul National University Hospital:
Total intravenous anesthesia
Maximum plasma concentration of remifentanil

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