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

NCT03066739 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-05-25

No results posted yet for this study

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.

Conditions

  • Hyperalgesia

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

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Ariana Nelson, MD · Associate Clinical Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-25
Primary Completion
2024-12-10
Completion
2024-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03066739 on ClinicalTrials.gov