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Drip-infusion of Remifentanil for RIH

Sponsor
Tri-Service General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04387097
Collaborator
(none)
559
Enrollment
1
Location
14.7
Actual Duration (Months)
38.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
559 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Postoperative Drip-infusion of Remifentanil for Preventing Remifentanil-induced Hyperalgesia- a Retrospective Observative Study
Actual Study Start Date :
May 1, 2018
Actual Primary Completion Date :
Jan 31, 2019
Actual Study Completion Date :
Jul 22, 2019

Arms and Interventions

Arm 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.

    Outcome Measures

    Primary Outcome Measures

    1. comparison of the numeric rating scale (NRS) between 2 groups [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.

    2. requirement for rescue analgesics [one hour]

      postoperative requirement for rescue analgesics

    Secondary Outcome Measures

    1. type of surgery [three hours]

      type of surgery in both groups

    2. surgical site [three hours]

      surgical site in both groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 TriService General Hospital Taipei Taiwan 11490

    Sponsors and Collaborators

    • Tri-Service General Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yi-hsuan Huang, Principal Investigator, Tri-Service General Hospital
    ClinicalTrials.gov Identifier:
    NCT04387097
    Other Study ID Numbers:
    • TSGHIRB No: 2-108-05-135
    First Posted:
    May 13, 2020
    Last Update Posted:
    May 15, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yi-hsuan Huang, Principal Investigator, Tri-Service General Hospital
    Remifentanil
    Hyperalgesia
    Drip-infusion
    Additional relevant MeSH terms:
    Hyperalgesia
    Remifentanil

    Study Results

    No Results Posted as of May 15, 2020