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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01025245
Other study ID # 4-2009-0511
Secondary ID
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


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
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