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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01025245
First Posted: December 3, 2009
Last Update Posted: June 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
November 27, 2009
December 3, 2009
June 16, 2010
November 2009
January 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01025245 on ClinicalTrials.gov Archive Site
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Effect of Intraoperative Magnesium on Remifentanil-induced Postoperative Hyperalgesia After Thyroidectomy
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The purpose of this study is to study the effect of intraoperative magnesium on remifentanil-induced postoperative hyperalgesia after thyroidectomy
Not Provided
Interventional
Phase 4
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Hyperalgesia
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.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
January 2010
January 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01025245
4-2009-0511
Yes
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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
Yonsei University
Not Provided
Not Provided
Yonsei University
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP