Drip-infusion of Remifentanil for RIH

Hyperalgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387097
• Other study ID #: TSGHIRB No: 2-108-05-135
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: July 22, 2019

Study information

• Verified date: May 2020
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 559
• Est. completion date: July 22, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperalgesia

Intervention

Drug:
• remifentanil
postoperative drip-infusion of remifentanil

Locations

Country	Name	City	State
Taiwan	TriService General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & 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. — View Citation

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 Anesthe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	requirement for rescue analgesics	postoperative requirement for rescue analgesics	one hour
Secondary	type of surgery	type of surgery in both groups	three hours
Secondary	surgical site	surgical site in both groups	three hours