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Not yet recruiting NCT01003028

Reduction of Remifentanil-related Complications

Phase IV Interventional Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remifentanil (Limited) - Target Controlled Infusion system, Remifentanil (Control) - Target Controlled Infusion system.
Who it may be relevant to
Registry conditions: Anesthesia. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Drug Remifentanil (Limited) - Target Controlled Infusion system
    Limit max plasma concentration to 9.8 ng/ml
  • Drug Remifentanil (Control) - Target Controlled Infusion system
    Use 20 ng/ml as max plasma concentration

Primary outcome measures

  • hypotension more than 25% from baseline [Time frame: during remifentanil loading]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT01003028 · CW Jung_TCI_Remi_Cpmax

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗