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

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High dose Remifentanil
Naloxone
Low dose remifentanil
Normal Saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring acute pain, postoperative, surgery

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

group LR

group HR

group HR-N

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mechanical pain thresholds
pain score
pain score

Full Information

First Posted
August 2, 2016
Last Updated
November 15, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02856087
Brief Title
The Effect of Ultra-low-dose Naloxone on Remifentanil-induced Postoperative Hyperalgesia - A Randomized Controlled Study
Official Title
The Effect of Ultra-low-dose Naloxone on Remifentanil-induced Postoperative Hyperalgesia - A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
acute pain, postoperative, surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group LR
Arm Type
Placebo Comparator
Arm Description
low dose remifentanil (1 ng/ml of Ce) with normal saline infusion
Arm Title
group HR
Arm Type
Active Comparator
Arm Description
High dose remifentanil infusion (4ng/ml of Ce) with normal saline infusion
Arm Title
group HR-N
Arm Type
Experimental
Arm Description
remifentanil infusion at 4ng/ml of Ce with naloxone infusion
Intervention Type
Drug
Intervention Name(s)
High dose Remifentanil
Intervention Description
remifentanil infusion at 4ng/ml of Ce
Intervention Type
Drug
Intervention Name(s)
Naloxone
Intervention Description
naloxone infusion
Intervention Type
Drug
Intervention Name(s)
Low dose remifentanil
Intervention Description
remifentanil infusion at 1ng/ml of Ce
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
normal saline infusion
Primary Outcome Measure Information:
Title
Mechanical pain thresholds
Description
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.
Time Frame
24hr after surgery
Secondary Outcome Measure Information:
Title
Mechanical pain thresholds
Time Frame
48hr after surgery
Title
pain score
Time Frame
verbal numerical rating scale at 24 hr after surgery
Title
pain score
Time Frame
verbal numerical rating scale at 48 after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunseok Jeon, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29029049
Citation
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.
Results Reference
derived

Learn more about this trial

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

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