Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2014 by Seoul National University Hospital
Information provided by (Responsible Party):
Chul-Woo Jung, Seoul National University Hospital Identifier:
First received: October 23, 2009
Last updated: November 17, 2014
Last verified: November 2014

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • hypotension more than 25% from baseline [ Time Frame: during remifentanil loading ] [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01003028

Contact: Ho Geol Ryu, MD, PhD 82-17-259-9173

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

No publications provided

Responsible Party: Chul-Woo Jung, Assistant professor, Seoul National University Hospital Identifier: NCT01003028     History of Changes
Other Study ID Numbers: CW Jung_TCI_Remi_Cpmax
Study First Received: October 23, 2009
Last Updated: November 17, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Total intravenous anesthesia
Maximum plasma concentration of remifentanil

Additional relevant MeSH terms:
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on February 27, 2015