Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery
1 other identifier
interventional
84
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 25, 2010
CompletedFirst Posted
Study publicly available on registry
August 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedAugust 27, 2010
August 1, 2010
11 months
August 25, 2010
August 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
sevoflurane
ACTIVE COMPARATORRemifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients who are in this group will be infused propofol intraoperatively.
propofol
EXPERIMENTALRemifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients included this group will be inhaled sevoflurane intraoperatively.
Interventions
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 Criteria
You may qualify if:
- Patients undergoing thyroidectomy
- Age 20-65
- American Society of Anesthesiologists physical status classification I or II
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gang Nam Severance Hospital, Yonsei University, Anesthesia and Pain Medicine Department,
Seoul, 135-270, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
yuen hee shim, MD
Gangnam severance hospital, Yonsei university, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Reseach Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 25, 2010
First Posted
August 27, 2010
Study Start
August 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
August 27, 2010
Record last verified: 2010-08