Effect of Intraoperative Magnesium on Remifentanil-induced Postoperative Hyperalgesia After Thyroidectomy

This study has been completed.

Sponsor:

Information provided by:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01025245

First received: November 27, 2009

Last updated: June 15, 2010

Last verified: June 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	November 27, 2009
Last Updated Date	June 15, 2010
Start Date ^ICMJE	November 2009
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 2, 2009)	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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01025245 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Intraoperative Magnesium on Remifentanil-induced Postoperative Hyperalgesia After Thyroidectomy
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to study the effect of intraoperative magnesium on remifentanil-induced postoperative hyperalgesia after thyroidectomy
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Hyperalgesia
Intervention ^ICMJE	Drug: remifentanil, MgSO4 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.
Study Arm (s)	Experimental: remifentanil, MgSO4 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: Drug: remifentanil, MgSO4
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	84
Completion Date	January 2010
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	20 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01025245
Other Study ID Numbers ^ICMJE	4-2009-0511
Has Data Monitoring Committee	Yes
Responsible Party	Yuen Hee Shim / Associate professor of Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Reseach Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
Study Sponsor ^ICMJE	Yonsei University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yonsei University
Verification Date	June 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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