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
Recruitment status was Recruiting
Sponsor:
Gangnam Severance Hospital
Information provided by:
Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT01189721
First received: August 25, 2010
Last updated: August 26, 2010
Last verified: August 2010
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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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| 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 Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives Platelet Aggregation Inhibitors Hematologic Agents Anesthetics, Inhalation Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013