Effect of Higher Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by Central South University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Central South University
Information provided by (Responsible Party):
Ru-Ping Dai, Central South University
ClinicalTrials.gov Identifier:
NCT01761149
First received: December 30, 2012
Last updated: January 3, 2013
Last verified: January 2013
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Purpose
Extensive clinical studies have shown that intraoperative infusion high dose of remifentanil (0.2ug/kg/min) induced postoperative hyperalgesia. Recent experimental study however suggests that higher dose of remifentanil may attenuate postoperative hyperalgesia. Thus, the present study is designed as a "proof of principle" study and hypothesizes that higher dose of remifentanil may reduce postoperative pain in patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Nodular Goiter |
Drug: Remifentanil |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Different Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy: a Prospective, Double-blinded Randomized Control Trial |
Resource links provided by NLM:
Further study details as provided by Central South University:
Primary Outcome Measures:
- Changes of sensory threshold from baseline to postoperative 24hours [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]Quantitative sensory threshold in the remote uninjured site (here, the inner forearm) is commonly used to examine the occurrence of postoperative hyperalgesia. The present study will examine the mechanical threshold in two different doses of remifentanil to determine whether high dose of remifentanil induces hyperalgesia
Secondary Outcome Measures:
- visual analogue score (VAS) [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]VAS is widely used to assess postoperative pain. It will be divided as 10 points. Zero refers to no pain and ten refers to extremely pain. Based on this way, we can know the difference of postoperative pain in these two different groups.
Other Outcome Measures:
- consumption of morphine postoperatively [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2012 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Remifentanil (Low dose)
remifentanil(Low):dose of 0.2ug/kg/min. The dose of remifentanil is widely used intraoperatively clinically;
|
Drug: Remifentanil
The present study examine two different dose of remifentanil: low dose (0.2ug/kg/min) and high dose (1.2ug/kg/min)
|
|
Experimental: Remifentanil (High dose)
The high dose of remifentanil is 1.2ug/kg/min. The does is sometimes used in clinical practice.
|
Drug: Remifentanil
The present study examine two different dose of remifentanil: low dose (0.2ug/kg/min) and high dose (1.2ug/kg/min)
|
Detailed Description:
Remifentanil, an ultra-short acting opioid, is widely used in the patients undergoing surgery. However, extensive studies report that remifentanil,administered at 0.2ug/kg/min or 0.4ug/kg/min intraoperatively, can result in postoperative hyperalgesia and increase the consumption of analgesics when compared with low dose (0.05ug/kg/min). However, a recent experimental study shows that large dose of remifentanil can inhibit pain hypersensitivity through erasing the spinal sensitization of pain. The present study thus hypothesizes that higher dose of remifentanil (1.2ug/kg/min) may attenuate postoperative pain. The present study will compare the effect of two different dose of remifentanil (0.2ug/kg/min and 1.2ug/kg/min) on postoperative pain. Patients undergoing thyroidectomy will be recruited, and mechanical threshold will be measured in the remote region of surgical site preoperatively. The patients will be randomly divided by two groups, 0.2ug/kg/min (group I) and 1.2ug/kg/min (group II). After operation, mechanical threshold and visual analogue scale (VAS) will be measured as the indicators of postoperative pain. The consumption of morphine will also be compared between these two doses of remifentanil.
The present study may find optimized dose of opioid usage in the patients undergoing surgery to relieve the postoperative pain.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ASA Grade I or II
- Age 18-60 years old
- BMI<35,
Exclusion Criteria:
- do not consent,
- Chronic pain,
- used pain killer,
- undergoing operation previously
- diabetes or the other diseases affecting the sensory.
- difficult intubation;
- unexpected surgical complication such as bleeding;
- psychiatric disorders;
- drug or alchohol abuse
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01761149
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761149
Contacts
| Contact: Ru-Ping Dai, MD, PhD | 86-731-8529 ext 5970 | Ruping_dai@yahoo.com.cn |
Locations
| China, Hunan | |
| Department of Anesthesiology, The Second Xiangya Hospital | Recruiting |
| Changsha, Hunan, China, 410011 | |
| Contact: Yan-Ling Zhang, MD 86-731-8529 ext 5970 zhangyanling0618@yahoo.cn | |
Sponsors and Collaborators
Central South University
Investigators
| Principal Investigator: | Ru-Ping Dai, MD | Central South University |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ru-Ping Dai, Associate Professor, MD, PhD, Central South University |
| ClinicalTrials.gov Identifier: | NCT01761149 History of Changes |
| Other Study ID Numbers: | XYEYYCT2013001 |
| Study First Received: | December 30, 2012 |
| Last Updated: | January 3, 2013 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Central South University:
|
remifentanil, opioid, hyperalgesia, visual analogue score thyroidectomy, |
Additional relevant MeSH terms:
|
Pain, Postoperative Goiter Goiter, Nodular Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms Thyroid Diseases Endocrine System Diseases Remifentanil |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on September 29, 2016