Reduction of Remifentanil-related Complications

Seoul National University

Status and phase: Not yet enrolling; Phase 4

Conditions: Anesthesia

Treatments: Drug: Remifentanil (Control) - Target Controlled Infusion system; Drug: Remifentanil (Limited) - Target Controlled Infusion system

Study type: Interventional

Funder types: Other

Identifiers

NCT01003028

CW Jung_TCI_Remi_Cpmax

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups

Limited

Experimental group

Description:

Limit the maximum plasma concentration target to 9.8 ng/ml

Treatment:

Drug: Remifentanil (Limited) - Target Controlled Infusion system

Control

Active Comparator group

Description:

Use 20 ng/ml as max plasma concentration

Treatment:

Drug: Remifentanil (Control) - Target Controlled Infusion system