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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Gangnam Severance Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT01189721
First received: August 25, 2010
Last updated: August 26, 2010
Last verified: August 2010

August 25, 2010
August 26, 2010
August 2010
July 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01189721 on ClinicalTrials.gov Archive Site
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Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery
Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyperalgesia
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.

  • Active Comparator: sevoflurane
    Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients who are in this group will be infused propofol intraoperatively.
    Intervention: Drug: propofol, sevoflurane
  • Experimental: propofol
    Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients included this group will be inhaled sevoflurane intraoperatively.
    Intervention: Drug: propofol, sevoflurane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
84
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact: young ju won, MD. 082-2-2019-6805 moma2@naver.com
Contact: yuen hee shim, MD. 082-2-2019-6808 tren125@yuhs.ac
Korea, Republic of
 
NCT01189721
3-2010-0102
Not Provided
Gang nam Severance Hospital, Anesthesia and Pain Research Institute, Anesthesia and Pain Research Institute
Gangnam Severance Hospital
Not Provided
Study Chair: yuen hee shim, MD Gangnam severance hospital, Yonsei university, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Reseach Institute
Gangnam Severance Hospital
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP