NCT02856087

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

August 2, 2016

Last Update Submit

November 15, 2016

Conditions

Pain

Keywords

acute painpostoperativesurgery

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Mechanical pain thresholds

    48hr after surgery

  • pain score

    verbal numerical rating scale at 24 hr after surgery

  • pain score

    verbal numerical rating scale at 48 after surgery

Study Arms (3)

group LR

PLACEBO COMPARATOR

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

Drug: Low dose remifentanilDrug: Normal Saline

group HR

ACTIVE COMPARATOR

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

Drug: High dose RemifentanilDrug: Normal Saline

group HR-N

EXPERIMENTAL

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

Drug: High dose RemifentanilDrug: Naloxone

Interventions

High dose RemifentanilDRUG

remifentanil infusion at 4ng/ml of Ce

group HRgroup HR-N
NaloxoneDRUG

naloxone infusion

group HR-N
Low dose remifentanilDRUG

remifentanil infusion at 1ng/ml of Ce

group LR
Normal SalineDRUG

normal saline infusion

group HRgroup LR

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who are scheduled to undergo elective thyroidectomy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 29029049DERIVED

MeSH Terms

Conditions

PainAcute Pain

Interventions

RemifentanilNaloxoneSaline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Yunseok Jeon, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 4, 2016

Study Start

November 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

November 16, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)