Reduction of Remifentanil-related Complications

NCT ID: NCT01003028

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-12-01

Brief Summary

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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

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Conditions

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Anesthesia

Keywords

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Total intravenous anesthesia Maximum plasma concentration of remifentanil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Limited

Limit the maximum plasma concentration target to 9.8 ng/ml

Group Type EXPERIMENTAL

Remifentanil (Limited) - Target Controlled Infusion system

Intervention Type DRUG

Limit max plasma concentration to 9.8 ng/ml

Control

Use 20 ng/ml as max plasma concentration

Group Type ACTIVE_COMPARATOR

Remifentanil (Control) - Target Controlled Infusion system

Intervention Type DRUG

Use 20 ng/ml as max plasma concentration

Interventions

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Remifentanil (Limited) - Target Controlled Infusion system

Limit max plasma concentration to 9.8 ng/ml

Intervention Type DRUG

Remifentanil (Control) - Target Controlled Infusion system

Use 20 ng/ml as max plasma concentration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chul-Woo Jung

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Ho Geol Ryu, MD, PhD

Role: CONTACT

Phone: 82-17-259-9173

Email: [email protected]

Facility Contacts

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Chul-Woo Jung, MD PhD

Role: primary

Other Identifiers

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CW Jung_TCI_Remi_Cpmax

Identifier Type: -

Identifier Source: org_study_id