Effect of Higher Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01761149 |
Recruitment Status : Unknown
Verified January 2013 by Ru-Ping Dai, Central South University.
Recruitment status was: Recruiting
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nodular Goiter | Drug: Remifentanil | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (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 |
Study Start Date : | December 2012 |
Estimated Primary Completion Date : | March 2013 |

Arm | Intervention/treatment |
---|---|
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) |
- Changes of sensory threshold from baseline to postoperative 24hours [ Time Frame: 24 hour ]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
- visual analogue score (VAS) [ Time Frame: 24 hours ]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.
- consumption of morphine postoperatively [ Time Frame: 24 hours ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01761149
Contact: Ru-Ping Dai, MD, PhD | 86-731-8529 ext 5970 | Ruping_dai@yahoo.com.cn |
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 |
Principal Investigator: | Ru-Ping Dai, MD | Central South University |
Responsible Party: | Ru-Ping Dai, Associate Professor, MD, PhD, Central South University |
ClinicalTrials.gov Identifier: | NCT01761149 |
Other Study ID Numbers: |
XYEYYCT2013001 |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | January 4, 2013 |
Last Verified: | January 2013 |
remifentanil, opioid, hyperalgesia, visual analogue score thyroidectomy, |
Goiter, Nodular Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Goiter 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 |