Drip-infusion of Remifentanil for RIH

Completed

• Conditions: Hyperalgesia
• Interventions: Drug: remifentanil

• Registration Number: NCT04387097
• Lead Sponsor: Tri-Service General Hospital

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.

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 Timeline

• Study Start: 2018-05-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-07-22
• Status Verified: 2020-05
• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-13
• Last Update Submitted: 2020-05-13
• Last Update Posted: 2020-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 559

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
gradual withdrawal following by drip-infusion of remifentanil	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.

Primary Outcome Measures

Name	Time	Method
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.
requirement for rescue analgesics	one hour	postoperative requirement for rescue analgesics

Secondary Outcome Measures

Name	Time	Method
type of surgery	three hours	type of surgery in both groups
surgical site	three hours	surgical site in both groups

Trial Locations

Locations (1)

TriService General Hospital; 🇨🇳 Taipei, Taiwan