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:
Seoul National University Hospital
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
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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
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 Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on June 18, 2013