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

Seoul National University

Status: Completed

Conditions: Pain

Treatments: Drug: Low dose remifentanil; Drug: Naloxone; Drug: High dose Remifentanil; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02856087

YSjeon_naloxone

Details and patient eligibility

About

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

Full description

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.

Enrollment: 92 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who are scheduled to undergo elective thyroidectomy

Exclusion criteria

• consent refusal, obesity, pregnancy, hx. of thyroid surgery, neurological disorders, psychiatric disorders, hx. of drug abuse or chronic use of opioids or sedative drugs, intake of any analgesic drug within 12h before surgery.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 3 patient groups, including a placebo group

group LR

Placebo Comparator group

Description:

low dose remifentanil (1 ng/ml of Ce) with normal saline infusion

Treatment:

Drug: Low dose remifentanil

Drug: Normal Saline

group HR

Active Comparator group

Description:

High dose remifentanil infusion (4ng/ml of Ce) with normal saline infusion

Treatment:

Drug: High dose Remifentanil

Drug: Normal Saline

group HR-N

Experimental group

Description:

remifentanil infusion at 4ng/ml of Ce with naloxone infusion

Treatment:

Drug: High dose Remifentanil

Drug: Naloxone