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Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery

Primary Purpose

Hyperalgesia

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
propofol, sevoflurane
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperalgesia focused on measuring remifentanil, hyperalgesia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing thyroidectomy
  • Age 20-65
  • American Society of Anesthesiologists physical status classification I or II

Exclusion Criteria:

  • History of chronic pain, Regular use of analgesic, antiepileptic or antidepressive drugs
  • History of drug & alcohol abuse
  • Psychiatric disorder
  • Use of opioids within 24hrs
  • Renal disease with decreased glomerular filtrate ratio
  • Neuromuscular disease, Severe cardiac disease

Sites / Locations

  • Gang Nam Severance Hospital, Yonsei University, Anesthesia and Pain Medicine Department,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

sevoflurane

propofol

Arm Description

Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients who are in this group will be infused propofol intraoperatively.

Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients included this group will be inhaled sevoflurane intraoperatively.

Outcomes

Primary Outcome Measures

Tactile pain thresholds adjacent to the surgical wound assessed by von Frey hair before the induction and at postoperative 24 & 48 hrs

Secondary Outcome Measures

Full Information

First Posted
August 25, 2010
Last Updated
August 26, 2010
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01189721
Brief Title
Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery
Official Title
Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

5. Study Description

Brief Summary
The investigators hypothesize that propofol infusion during surgery can affect the remifentanil hyperalgesia compared to sevoflurane inhalation.The outcome will be measured by a verbal numerical rating score (VNRS) and mechanical punctuating pain by electronic von frey filament.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalgesia
Keywords
remifentanil, hyperalgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sevoflurane
Arm Type
Active Comparator
Arm Description
Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients who are in this group will be infused propofol intraoperatively.
Arm Title
propofol
Arm Type
Experimental
Arm Description
Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients included this group will be inhaled sevoflurane intraoperatively.
Intervention Type
Drug
Intervention Name(s)
propofol, sevoflurane
Intervention Description
Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min (group1 and 2) group 1 (Active Comparator, sevoflurane)will be infused propofol intraoperatively. group 2(Experimental, propofol) will be inhaled sevoflurane intraoperatively.
Primary Outcome Measure Information:
Title
Tactile pain thresholds adjacent to the surgical wound assessed by von Frey hair before the induction and at postoperative 24 & 48 hrs
Time Frame
postoperative 48 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing thyroidectomy Age 20-65 American Society of Anesthesiologists physical status classification I or II Exclusion Criteria: History of chronic pain, Regular use of analgesic, antiepileptic or antidepressive drugs History of drug & alcohol abuse Psychiatric disorder Use of opioids within 24hrs Renal disease with decreased glomerular filtrate ratio Neuromuscular disease, Severe cardiac disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
young ju won, MD.
Phone
082-2-2019-6805
Email
moma2@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
yuen hee shim, MD.
Phone
082-2-2019-6808
Email
tren125@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yuen hee shim, MD
Organizational Affiliation
Gangnam severance hospital, Yonsei university, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Reseach Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Gang Nam Severance Hospital, Yonsei University, Anesthesia and Pain Medicine Department,
City
Seoul
ZIP/Postal Code
135-270
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
young ju won, MD
Phone
082-2-2019-6805
Email
moma2@naver.com
First Name & Middle Initial & Last Name & Degree
young ju won, MD

12. IPD Sharing Statement

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Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery

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