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

NCT ID: NCT02856087

Last Updated: 2016-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-04-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Pain

Keywords

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acute pain postoperative surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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group LR

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

Group Type PLACEBO_COMPARATOR

Low dose remifentanil

Intervention Type DRUG

remifentanil infusion at 1ng/ml of Ce

Normal Saline

Intervention Type DRUG

normal saline infusion

group HR

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

Group Type ACTIVE_COMPARATOR

High dose Remifentanil

Intervention Type DRUG

remifentanil infusion at 4ng/ml of Ce

Normal Saline

Intervention Type DRUG

normal saline infusion

group HR-N

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

Group Type EXPERIMENTAL

High dose Remifentanil

Intervention Type DRUG

remifentanil infusion at 4ng/ml of Ce

Naloxone

Intervention Type DRUG

naloxone infusion

Interventions

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High dose Remifentanil

remifentanil infusion at 4ng/ml of Ce

Intervention Type DRUG

Naloxone

naloxone infusion

Intervention Type DRUG

Low dose remifentanil

remifentanil infusion at 1ng/ml of Ce

Intervention Type DRUG

Normal Saline

normal saline infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yunseok Jeon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yunseok Jeon, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Koo CH, Yoon S, Kim BR, Cho YJ, Kim TK, Jeon Y, Seo JH. Intraoperative naloxone reduces remifentanil-induced postoperative hyperalgesia but not pain: a randomized controlled trial. Br J Anaesth. 2017 Dec 1;119(6):1161-1168. doi: 10.1093/bja/aex253.

Reference Type DERIVED
PMID: 29029049 (View on PubMed)

Other Identifiers

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YSjeon_naloxone

Identifier Type: -

Identifier Source: org_study_id