Drip-infusion of Remifentanil for RIH

NCT ID: NCT04387097

Last Updated: 2020-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

559 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-07-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hyperalgesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

remifentanil

Intervention Type DRUG

postoperative drip-infusion of remifentanil

gradual withdrawal of remifentanil

In the end of the surgery, gradual withdrawal of remifentanil was prescribed until the endotracheal tube was extubated.

No interventions assigned to this group

Interventions

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remifentanil

postoperative drip-infusion of remifentanil

Intervention Type DRUG

Other Intervention Names

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drip-infusion

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yi-hsuan Huang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi-hsuan Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital and National Defense Medical Center

Locations

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TriService General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Comelon M, Raeder J, Stubhaug A, Nielsen CS, Draegni T, Lenz H. Gradual withdrawal of remifentanil infusion may prevent opioid-induced hyperalgesia. Br J Anaesth. 2016 Apr;116(4):524-30. doi: 10.1093/bja/aev547. Epub 2016 Mar 1.

Reference Type RESULT
PMID: 26934941 (View on PubMed)

Saxena S, Gonsette K, Terram W, Huybrechts I, Nahrwold DA, Cappello M, Barvais L, Engelman E. Gradual withdrawal of remifentanil delays initial post-operative analgesic demand after thyroid surgery; double-blinded, randomized controlled trial. BMC Anesthesiol. 2019 Apr 25;19(1):60. doi: 10.1186/s12871-019-0731-9.

Reference Type RESULT
PMID: 31027480 (View on PubMed)

Other Identifiers

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TSGHIRB No: 2-108-05-135

Identifier Type: -

Identifier Source: org_study_id

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