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Effect of Higher Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy

Information source: Central South University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nodular Goiter

Intervention: Remifentanil (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Central South University

Official(s) and/or principal investigator(s):
Ru-Ping Dai, MD, Principal Investigator, Affiliation: Central South University

Overall contact:
Ru-Ping Dai, MD, PhD, Phone: 86-731-8529, Ext: 5970, Email: Ruping_dai@yahoo.com.cn


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.

Clinical Details

Official title: Comparison of Different Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy: a Prospective, Double-blinded Randomized Control Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Changes of sensory threshold from baseline to postoperative 24hours

Secondary outcome: visual analogue score (VAS)

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.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


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

Locations and Contacts

Ru-Ping Dai, MD, PhD, Phone: 86-731-8529, Ext: 5970, Email: Ruping_dai@yahoo.com.cn

Department of Anesthesiology, The Second Xiangya Hospital, Changsha, Hunan 410011, China; Recruiting
Yan-Ling Zhang, MD, Phone: 86-731-8529, Ext: 5970, Email: zhangyanling0618@yahoo.cn
Additional Information

Starting date: December 2012
Last updated: January 3, 2013

Page last updated: August 23, 2015

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