An interventional study of Dexamethasone and saline in Wound Infection, sponsored by Quanhong Zhou. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-11-30.
Sponsored by Quanhong Zhou · Not applicable, Interventional, and Prevention
Dexamethasone is a potent glucocorticoid with analgesic and anti-emetic effects [1-3]. Perioperative single-dose dexamethasone therapy has been used for several purposes: to reduce post-operative nausea and vomiting (PONV), pain and sore throat. There are also some reports on beneficial effects of less cardiac arrhythmia, improved appetite and less edema from glucocorticoids. Preoperative small dose of dexamethasone was reported to prevent reversal laryngeal nerve injury and improve voice quality after thyroid surgery. While accepted wildly in clinical anesthesia practice, the immune-press related potential risks of side effects associated with dexamethasone, such as delayed wound healing, infection, as well as effects on blood sugar, make the use of perioperative single dose of glucocorticoid controversial. The effect of perioperative dexamethasone on wound healing varied with different types of surgery. The present study will observe the effect of dexamethasone on the safety of thyroid surgery.
Patients who has the thyroid surgery for their thyroid cancer will be randomly allocated into two groups, either dexamethasone group or saline group. In the dexamethasone group, patients will receive 5mg dexamethasone iv right after general anesthesia induction while in the saline group, patients will have 1ml saline iv. The drainage fluid will be collected at 6 hours after surgery and on every morning after operation till the drainage tube is taken out. The total amount of drainage fluid and blood stain area in dressing will be collected and calculated after the operation. The C-reaction protein is checked in drainage fluid and in blood after operation. Besides, the pain scores of incision pain and throat pain will be evaluated. Postoperative nausea and vomit will be checked as well.
382 studies on the registry are indexed under Wound Infection; 40 are open to participants now.
This study's enrollment of 220 is above the median of 150 across 296 interventional studies indexed under Wound Infection.
Browse Wound Infection studies →This is the only study on the registry with Quanhong Zhou as lead sponsor.
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Exclusion Criteria:
Group D: dexamethasone group
Drug: Dexamethasone
Group S: saline group
Drug: saline
dexamethasone 1ml (5mg)
saline 1ml
the total wound drain after the operation, including the drain in bulb and stain area in dressings,
Time frame: from postoperative day 0 to postoperative day 4
patient pain scores, including incision pain and throat pain,
Time frame: from postoperative day 0 to one month after operation
c-reaction protein levels in drainage fluid and blood during perioperative period.
Time frame: from postoperative day 0 to postoperative day 4
patient nausea/vomiting scores
Time frame: from postoperative day 0 to 3 days after operation
other side effects from the surgery
Time frame: from postoperative day 0 to one month after the operation
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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