Reduction of Remifentanil-related Complications

November 29, 2023 updated by: Chul-Woo Jung, Seoul National University Hospital

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ho Geol Ryu, MD, PhD
  • Phone Number: 82-17-259-9173
  • Email: hogeol@gmail.com

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Chul Woo Jung, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Limited
Limit the maximum plasma concentration target to 9.8 ng/ml
Drug: Remifentanil (Limited) - Target Controlled Infusion system
Limit max plasma concentration to 9.8 ng/ml
Active Comparator: Control
Use 20 ng/ml as max plasma concentration
Drug: Remifentanil (Control) - Target Controlled Infusion system
Use 20 ng/ml as max plasma concentration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hypotension more than 25% from baseline
Time Frame: during remifentanil loading
during remifentanil loading

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 23, 2009

First Submitted That Met QC Criteria

October 27, 2009

First Posted (Estimated)

October 28, 2009

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CW Jung_TCI_Remi_Cpmax

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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