Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery

Hyperalgesia Clinical Trial

Official title:

Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01189721
• Other study ID #: 3-2010-0102
• Status: Recruiting
• Phase: Phase 4
• First received: August 25, 2010
• Last updated: August 26, 2010
• Start date: August 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2010
• Source: Gangnam Severance Hospital
• Contact: young ju won, MD.
• Phone: 082-2-2019-6805
• Email: moma2[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that propofol infusion during surgery can affect the remifentanil hyperalgesia compared to sevoflurane inhalation.The outcome will be measured by a verbal numerical rating score (VNRS) and mechanical punctuating pain by electronic von frey filament.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• 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 glomerular filtrate ratio

• Neuromuscular disease, Severe cardiac disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperalgesia

Intervention

Drug:
• propofol, sevoflurane
Remifentanil will be infused intraoperatively at 0.2 ?/?/min (group1 and 2) group 1 (Active Comparator, sevoflurane)will be infused propofol intraoperatively. group 2(Experimental, propofol) will be inhaled sevoflurane intraoperatively.

Locations

Country	Name	City	State
Korea, Republic of	Gang Nam Severance Hospital, Yonsei University, Anesthesia and Pain Medicine Department,	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

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