Drip-infusion of Remifentanil for RIH

NCT04387097 | Completed

• 1 other identifier: TSGHIRB No: 2-108-05-135
• Study Type: observational
• Target: 559
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperalgesia

Keywords

Remifentanil; Hyperalgesia; Drip-infusion

Outcome Measures

Primary Outcomes (2)

• comparison of the numeric rating scale (NRS) between 2 groups

  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

  postoperative requirement for rescue analgesics

  one hour

Secondary Outcomes (2)

• type of surgery

  three hours

• surgical site

  three hours

Study Arms (2)

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

gradual withdrawal of remifentanil

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

Interventions

remifentanil DRUG

postoperative drip-infusion of remifentanil

Also known as: drip-infusion

gradual withdrawal following by drip-infusion of remifentanil

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients receiving surgery with age between 20-80 years

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

TriService General Hospital

Taipei, 11490, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 26934941 RESULT

• 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.

  PMID: 31027480 RESULT

MeSH Terms

Conditions

Hyperalgesia

Interventions

Remifentanil; Infusions, Intravenous

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Officials

• Yi-hsuan Huang, MD

  Tri-Service General Hospital and National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 13, 2020
• Study Start: May 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: July 22, 2019
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)