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NCT Number: NCT01003028

Reduction of Remifentanil-related Complications

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.

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Key information

Conditions

Anesthesia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location contact

Chul Woo Jung, MD PhD

PRINCIPAL_INVESTIGATOR

Chul-Woo Jung, MD PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil (Limited) - Target Controlled Infusion system

Drug

Limit max plasma concentration to 9.8 ng/ml

Remifentanil (Control) - Target Controlled Infusion system

Drug

Use 20 ng/ml as max plasma concentration

Primary outcomes

hypotension more than 25% from baseline

Time frame: during remifentanil loading

Study contacts

Contact information is provided by the study sponsor or research team.

Ho Geol Ryu, MD, PhD

CONTACT

[email protected]

82-17-259-9173

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Oct 28, 2009
Registry last updated: Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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