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

NCT ID: NCT01025245

Last Updated: 2010-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-01-31

Brief Summary

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

Conditions

Hyperalgesia

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

remifentanil, MgSO4

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Yonsei University College of Medicine, Seoul, Republic of Korea

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2009-0511

Identifier Type: -

Identifier Source: org_study_id