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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Seoul National University Hospital.
Recruitment status was  Not yet recruiting
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
  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
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 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 23, 2009
Last Updated: May 1, 2012
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:
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on October 02, 2014