Reduction of Remifentanil-related Complications

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01003028

Enrollment

160

Registered

2009-10-28

Start date

2024-11-01

Completion date

2026-12-01

Last updated

2023-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Total intravenous anesthesia, Maximum plasma concentration of remifentanil

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.

Interventions

DRUGRemifentanil (Limited) - Target Controlled Infusion system

Limit max plasma concentration to 9.8 ng/ml

DRUGRemifentanil (Control) - Target Controlled Infusion system

Use 20 ng/ml as max plasma concentration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
hypotension more than 25% from baseline	during remifentanil loading

Countries

South Korea

Contacts

Primary ContactHo Geol Ryu, MD, PhD

hogeol@gmail.com82-17-259-9173

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026