Back to resultsEffect of Intraoperative Magnesium on Remifentanil-induced Postoperative Hyperalgesia After Thyroidectomy
Primary Purpose
Hyperalgesia
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
remifentanil, MgSO4
Sponsored by
About this trial
This is an interventional prevention trial for Hyperalgesia focused on measuring Remifentanil induced postoperative hyperalgesia
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 GFR,
- Neuromuscular disease, Severe cardiac disease.
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
remifentanil, MgSO4
Arm Description
Experimental 1 : Intraoperative remifentanil infusion at 0.2 ㎍/㎏/min and MgSO4 30 mg/kg IV at the induction followed by intraoperative infusion at 10 mg/kg/hr Drug : remifentanil, MgSO4 Experimental 2 : Intraoperative remifentanil infusion at 0.2 ㎍/㎏/min and normal saline Drug : remifentanil Active comparator : Intraoperative remifentanil infusion at 0.05 ㎍/㎏/min and normal saline Drug : remifentanil
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
1. Study Identification
Unique Protocol Identification Number
NCT01025245
Brief Title
Effect of Intraoperative Magnesium on Remifentanil-induced Postoperative Hyperalgesia After Thyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to study the effect of intraoperative magnesium on remifentanil-induced postoperative hyperalgesia after thyroidectomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalgesia
Keywords
Remifentanil induced postoperative hyperalgesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
remifentanil, MgSO4
Arm Type
Experimental
Arm Description
Experimental 1 : Intraoperative remifentanil infusion at 0.2 ㎍/㎏/min and MgSO4 30 mg/kg IV at the induction followed by intraoperative infusion at 10 mg/kg/hr Drug : remifentanil, MgSO4 Experimental 2 : Intraoperative remifentanil infusion at 0.2 ㎍/㎏/min and normal saline Drug : remifentanil Active comparator : Intraoperative remifentanil infusion at 0.05 ㎍/㎏/min and normal saline Drug : remifentanil
Intervention Type
Drug
Intervention Name(s)
remifentanil, MgSO4
Intervention Description
Patients undergoing thyroidectomy will be randomly assigned to one of three groups. Remifentanil will be infused intraoperatively at 0.05 ㎍/㎏/min (group Ⅰ) or 0.2 ㎍/㎏/min (group Ⅱ & Ⅲ). Patients in group Ⅲ will be received 30 ㎎/㎏ MgSO4 at the induction of general anesthesia followed by a maintenance infusion of 10 ㎎/㎏/hr intraoperatively until skin closure.
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 GFR,
Neuromuscular disease, Severe cardiac disease.
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Intraoperative Magnesium on Remifentanil-induced Postoperative Hyperalgesia After Thyroidectomy
We'll reach out to this number within 24 hrs