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

Hyperalgesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025245
• Other study ID #: 4-2009-0511
• Status: Completed
• Phase: Phase 4
• First received: November 27, 2009
• Last updated: June 15, 2010
• Start date: November 2009
• Est. completion date: January 2010

Study information

• Verified date: June 2010
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to study the effect of intraoperative magnesium on remifentanil-induced postoperative hyperalgesia after thyroidectomy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperalgesia

Intervention

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 ?) or 0.2 ?/?/min (group ? & ?). Patients in group ? will be received 30 ?/? MgSO4 at the induction of general anesthesia followed by a maintenance infusion of 10 ?/?/hr intraoperatively until skin closure.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tactile pain thresholds adjacent to the surgical wound assessed by von Frey hair before the induction and at postoperative 24 & 48 hrs		postoperative 48 hrs	No