An interventional study of High dose Remifentanil and Naloxone in Pain, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-11-16.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention
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
We enrolled adult patients undergoing thyroidectomy under general anesthesia with desflurane and remifentanil. Remifentanil was administered via target-controlled infusion and anesthetic depth was maintained keeping the BIS between 40 and 60. Patients were randomized into one of three groups depending on intraoperative doses of remifentanil and naloxone: effect-site concentrations of remifentanil 1 ng/ml (control group), 4 ng/ml (remifentanil group), and 4 ng/ml combined with infusion rate 0.8 ng/kg/min of naloxone (remifentanil and naloxone group). Postoperative mechanical pain thresholds, pain intensity, and analgesic consumption were examined during 48 h of postoperative period. The primary outcome was mechanical pain threshold measured on the peri-incisional area 24 h after surgery.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 92 is above the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
low dose remifentanil (1 ng/ml of Ce) with normal saline infusion
Drug: Low dose remifentanil · Drug: Normal Saline
High dose remifentanil infusion (4ng/ml of Ce) with normal saline infusion
Drug: High dose Remifentanil · Drug: Normal Saline
remifentanil infusion at 4ng/ml of Ce with naloxone infusion
Drug: High dose Remifentanil · Drug: Naloxone
remifentanil infusion at 4ng/ml of Ce
naloxone infusion
remifentanil infusion at 1ng/ml of Ce
normal saline infusion
Mechanical pain thresholds
Mechanical pain thresholds were assessed by von Frey filaments. The patients were asked to close their eyes during the test, and an investigator made the filament pressing the skin perpendicularly against the skin until bowing and being maintained for 1.5 seconds. The filament size was started from 0.4 g and was increased to the point until the patient perceives a clear change in sensation.
Time frame: 24hr after surgery
Mechanical pain thresholds
Time frame: 48hr after surgery
pain score
Time frame: verbal numerical rating scale at 24 hr after surgery
pain score
Time frame: verbal numerical rating scale at 48 after surgery
Plan to share: No
The record gives a start of Nov 2014, a primary completion of Apr 2015 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Remifentanil · Naloxone
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