Drip-infusion of Remifentanil for RIH

May 13, 2020 updated by: Yi-hsuan Huang, Tri-Service General Hospital

Postoperative Drip-infusion of Remifentanil for Preventing Remifentanil-induced Hyperalgesia- a Retrospective Observative Study

The development of remifentanil-induced hyperalgesia (RIH) is an unpleasant experience for surgical patients. An alternative management, gradual withdrawal of remifentanil was effective in prevention of RIH. The investigators designed a simple modality to assess if under withdrawal of remifentanil and further drip-infusion of remifentanil immediately after extubation affected postoperative pain score, the requirement of rescue analgesics, and adverse effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In clinical practice, the gradual withdrawal of remifentanil during surgery is unsatisfied. Thus, the investigators conducted a simple modality in a single center retrospective cohort study to assess how under baseline gradual withdrawal of remifentanil and further drip infusion of remifentanil immediately after extubation affected postoperative pain score and use of analgesics.

Study Type

Observational

Enrollment (Actual)

559

Contacts and Locations

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

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11490
        • TriService General Hospital

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

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients receiving surgery with age between 20-80 years

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) score of I-III patients receiving total intravenous anesthesia

Exclusion Criteria:

  • The use of inhalation agents or propofol combined with inhalation anesthesia
  • Pregnancy
  • Previous substance abuse
  • Known allergies to opioids, propofol or any drugs used in the study
  • History of neuropsychiatric disorder
  • Age < 20 years or > 80 years

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
gradual withdrawal following by drip-infusion of remifentanil
In the end of the surgery, gradual withdrawal of remifentanil was prescribed until the endotracheal tube was extubated. Following by drip-infusion of remifentanil for 30 minutes was administered immediately after tracheal extubation.
Drug: remifentanil
postoperative drip-infusion of remifentanil
Other Names:
  • drip-infusion
gradual withdrawal of remifentanil
In the end of the surgery, gradual withdrawal of remifentanil was prescribed until the endotracheal tube was extubated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of the numeric rating scale (NRS) between 2 groups
Time Frame: one hour
NRS scores is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.
one hour
requirement for rescue analgesics
Time Frame: one hour
postoperative requirement for rescue analgesics
one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
type of surgery
Time Frame: three hours
type of surgery in both groups
three hours
surgical site
Time Frame: three hours
surgical site in both groups
three hours

Collaborators and Investigators

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

Sponsor

Tri-Service General Hospital

Investigators

  • Principal Investigator: Yi-hsuan Huang, MD, Tri-Service General Hospital and National Defense Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 1, 2018

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

July 22, 2019

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2020

Last Update Submitted That Met QC Criteria

May 13, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSGHIRB No: 2-108-05-135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is not a plan to make IPD available.

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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