Dexamethasone and Wound Healing After Thyroid Surgery

Not Applicable

Completed

• Conditions: Wound Infection
• Interventions: Drug: saline; Drug: Dexamethasone

• Registration Number: NCT02304250
• Lead Sponsor: Quanhong Zhou

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-11-19
• Study First Submitted QC: 2014-11-25
• Study First Posted: 2014-12-01
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-25
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Elective total thyroidectomy or hemithyroidectomy with lymphadenectomy for thyroid cancer

Read More

Exclusion Criteria

• Age > 65 years, < 18 years
• Thyroid tumor with Grave's disease
• Thyroid tumor size over 5 cm
• Second or more than 2 times for thyroid surgery
• Non-traditional pathway for thyroid surgery
• ASA > II
• Pharyngitis
• Smoking, alcohol drinking history
• Contraindication or long term use of dexamethasone (allege, ulcer bleeding history, et al)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group S	saline	Group S: saline group
Group D	Dexamethasone	Group D: dexamethasone group

Primary Outcome Measures

Name	Time	Method
the total wound drain after the operation, including the drain in bulb and stain area in dressings,	from postoperative day 0 to postoperative day 4

Secondary Outcome Measures

Name	Time	Method
patient pain scores, including incision pain and throat pain,	from postoperative day 0 to one month after operation
c-reaction protein levels in drainage fluid and blood during perioperative period.	from postoperative day 0 to postoperative day 4

Trial Locations

Locations (1)

Shanghai 6Th People'S Hospital; 🇨🇳 Shanghai, Shanghai, China