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TERMINATED
NCT03066739
PHASE2

Effect of Ultra-low Dose Naloxone on Remifentanil-Induced Hyperalgesia

Sponsor: University of California, Irvine

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate whether using ultra-low dose naloxone, an opioid antagonist, has the potential to block remifentanil-induced hyperalgesia and tolerance following surgery. There are 3 study groups: (1) low dose remifentanil (LO, 0.1 micrograms/kg/mL), (2) high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL), or (3) high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone). The hypothesis of the study is that occurrence of remifentanil-induced hyperalgesia (low score in mechanical pain threshold) in the HN group will be lower than in the HI group.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2023-02-25

Completion Date

2025-12-01

Last Updated

2026-06-04

Healthy Volunteers

No

Conditions

Interventions

DRUG

Remifentanil

0.1 micrograms/kg/mL

DRUG

Remifentanil+ Placebo

high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)

DRUG

Remifentanil +ultra-low dose naloxone

high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone

Locations (1)

UC Irvine Medical Center

Orange, California, United States