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NCT01003028 Clinical Trial

Reduction of Remifentanil-related Complications

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01003028
Other study ID # CW Jung_TCI_Remi_Cpmax
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date November 1, 2024
Est. completion date December 1, 2026

Study information
Verified date November 2023
Source Seoul National University Hospital
Contact Ho Geol Ryu, MD, PhD
Phone 82-17-259-9173
Email hogeol@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 160
Est. completion date December 1, 2026
Est. primary completion date December 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Remifentanil (Limited) - Target Controlled Infusion system
Limit max plasma concentration to 9.8 ng/ml
• Remifentanil (Control) - Target Controlled Infusion system
Use 20 ng/ml as max plasma concentration

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary hypotension more than 25% from baseline during remifentanil loading
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