A Phase 4 interventional study of Remifentanil in Nodular Goiter, sponsored by Central South University. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-01-04.
Sponsored by Central South University · Phase 4, Interventional, and Treatment
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.
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.
19 studies on the registry are indexed under Goiter, Nodular; 6 are open to participants now.
This study's planned enrollment of 60 is below the median of 68 across 11 interventional studies indexed under Goiter, Nodular.
Browse Goiter, Nodular studies →Central South University is the lead sponsor of 134 studies on the registry; 32 are open to participants now.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
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BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
remifentanil(Low):dose of 0.2ug/kg/min. The dose of remifentanil is widely used intraoperatively clinically;
Drug: Remifentanil
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
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
Time frame: 24 hour
visual analogue score (VAS)
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.
Time frame: 24 hours
consumption of morphine postoperatively
Time frame: 24 hours
This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Remifentanil