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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856087
• Other study ID #: YSjeon_naloxone
• Status: Completed
• Phase: N/A
• First received: August 2, 2016
• Last updated: November 15, 2016
• Start date: November 2014
• Est. completion date: April 2015

Study information

• Verified date: November 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperalgesia
• Pain

Intervention

Drug:
• High dose Remifentanil
remifentanil infusion at 4ng/ml of Ce
• Naloxone
naloxone infusion
• Low dose remifentanil
remifentanil infusion at 1ng/ml of Ce
• Normal Saline
normal saline infusion

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24hr after surgery	Yes
Secondary	Mechanical pain thresholds		48hr after surgery	Yes
Secondary	pain score		verbal numerical rating scale at 24 hr after surgery	Yes
Secondary	pain score		verbal numerical rating scale at 48 after surgery	Yes