Reduction of Remifentanil-related Complications

Phase 4Not Yet RecruitingNCT01003028

Seoul National University Hospital160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

160

Conditions

Anesthesia

Interventions

Remifentanil (Limited) - Target Controlled Infusion systemDRUG

Limit max plasma concentration to 9.8 ng/ml

Remifentanil (Control) - Target Controlled Infusion systemDRUG

Use 20 ng/ml as max plasma concentration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

hypotension more than 25% from baseline

Time frame: during remifentanil loading

Central Contacts

Ho Geol Ryu, MD, PhD

CONTACT

82-17-259-9173 hogeol@gmail.com

Data from ClinicalTrials.gov

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