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