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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:
Information provided by:
Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT01189721
First received: August 25, 2010
Last updated: August 26, 2010
Last verified: August 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 65 Years   (Adult)
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 glomerular filtrate ratio
  • Neuromuscular disease, Severe cardiac disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01189721

Locations
Korea, Republic of
Gang Nam Severance Hospital, Yonsei University, Anesthesia and Pain Medicine Department,
Seoul, Korea, Republic of, 135-270
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 
Study First Received: August 25, 2010
Last Updated: August 26, 2010
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 06, 2016