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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. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by Gangnam Severance Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01189721
First Posted: August 27, 2010
Last Update Posted: August 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gangnam Severance Hospital
  Purpose
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.

Condition Intervention Phase
Hyperalgesia Drug: propofol, sevoflurane Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery

Resource links provided by NLM:


Further study details as provided by Gangnam Severance Hospital:

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 ]

Estimated Enrollment: 84
Study Start Date: August 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sevoflurane
Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients who are in this group will be infused propofol intraoperatively.
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.

Experimental: propofol
Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients included this group will be inhaled sevoflurane intraoperatively.
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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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 glomerular filtrate ratio
  • Neuromuscular disease, Severe cardiac disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189721


Contacts
Contact: young ju won, MD. 082-2-2019-6805 moma2@naver.com
Contact: yuen hee shim, MD. 082-2-2019-6808 tren125@yuhs.ac

Locations
Korea, Republic of
Gang Nam Severance Hospital, Yonsei University, Anesthesia and Pain Medicine Department, Recruiting
Seoul, Korea, Republic of, 135-270
Contact: young ju won, MD    082-2-2019-6805    moma2@naver.com   
Sub-Investigator: young ju won, MD         
Sponsors and Collaborators
Gangnam Severance Hospital
Investigators
Study Chair: yuen hee shim, MD Gangnam severance hospital, Yonsei university, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Reseach Institute
  More Information

Responsible Party: Gang nam Severance Hospital, Anesthesia and Pain Research Institute, Anesthesia and Pain Research Institute
ClinicalTrials.gov Identifier: NCT01189721     History of Changes
Other Study ID Numbers: 3-2010-0102
First Submitted: August 25, 2010
First Posted: August 27, 2010
Last Update Posted: August 27, 2010
Last Verified: August 2010

Keywords provided by Gangnam Severance Hospital:
remifentanil
hyperalgesia

Additional relevant MeSH terms:
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Propofol
Remifentanil
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation