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
  Purpose

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


Condition Intervention Phase
Hyperalgesia
Drug: remifentanil, MgSO4
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Yonsei University:

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 [ Time Frame: postoperative 48 hrs ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: November 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025245

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

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
ClinicalTrials.gov Identifier: NCT01025245     History of Changes
Other Study ID Numbers: 4-2009-0511
Study First Received: November 27, 2009
Last Updated: June 15, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
Remifentanil induced postoperative hyperalgesia

Additional relevant MeSH terms:
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on April 16, 2014