drugset / Trial / NCT02856087

The Effect of Ultra-low-dose Naloxone on Remifentanil-induced Postoperative Hyperalgesia - A Randomized Controlled Study

NCT02856087 ↗

Completed 92 enrolled Seoul National University Hospital
RandomizedParallel-groupQuadruple-blindPrevention

Summary

High-dose remifentanil infused intraoperative ironically results in postoperative hyperalgesia. Ultra-low dose nalxone is demonstrated to prevent these opioid-induced hyperalgesia in animal model. In this clinical trial in patients undergoing general anesthesia with remifentanil, we evaluate the effects of ultra-low-dose naloxone on remifentanil-induced hyperalgesia

Timeline

Start
2014-11
Primary completion
2015-04
Completion
2015-04

Outcome

Met primary endpoint

paper significantly lower in the high-remifentanil group (n=31) than in the high-remifentanil with naloxone (n=30) and the low-remifentanil (n=30) groups PMID 29029049 ↗

paper 3.63 (3.22-3.84) vs 3.84 (3.76-4.00) vs 3.80 (3.69-4.08), P=0.011 PMID 29029049 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Naloxone Small molecule 0.8 ng/ml —
Subject Remifentanil Small molecule 1 ng/ml —
Subject Remifentanil Small molecule 4 ng/ml —

Indications

No indication recorded.