Clinical trial NCT01761149: Effect of Higher Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy
Official title: Comparison of Different Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy: a Prospective, Double-blinded Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nodular Goiter
Keywords: remifentanil,
opioid,
hyperalgesia,
visual analogue score
thyroidectomy,
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Changes of sensory threshold from baseline to postoperative 24hours
timeFrame: 24 hour
Secondary outcomes:
measure: visual analogue score (VAS)
timeFrame: 24 hours
Other outcomes:
measure: consumption of morphine postoperatively
timeFrame: 24 hours
Locations:
city: Changsha
country: China
facility: Department of Anesthesiology, The Second Xiangya Hospital
state: Hunan
Study officials:
affiliation: Central South University
name: Ru-Ping Dai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang YL, Ou P, Lu XH, Chen YP, Xu JM, Dai RP. Effect of intraoperative high-dose remifentanil on postoperative pain: a prospective, double blind, randomized clinical trial. PLoS One. 2014 Mar 25;9(3):e91454. doi: 10.1371/journal.pone.0091454. eCollection 2014.