Reduction of Remifentanil-related Complications

Phase 4

Not yet recruiting

• Conditions: Anesthesia
• Interventions: Drug: Remifentanil (Limited) - Target Controlled Infusion system; Drug: Remifentanil (Control) - Target Controlled Infusion system

• Registration Number: NCT01003028
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-23
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-01
• Study Start: 2024-11-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Limited	Remifentanil (Limited) - Target Controlled Infusion system	Limit the maximum plasma concentration target to 9.8 ng/ml
Control	Remifentanil (Control) - Target Controlled Infusion system	Use 20 ng/ml as max plasma concentration

Primary Outcome Measures

Name	Time	Method
hypotension more than 25% from baseline	during remifentanil loading

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of