Dexamethasone and Wound Healing After Thyroid Surgery

Quanhong Zhou

Status: Completed

Conditions: Wound Infection

Treatments: Drug: Dexamethasone; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02304250

2014-50

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective total thyroidectomy or hemithyroidectomy with lymphadenectomy for thyroid cancer

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups, including a placebo group

Group D

Active Comparator group

Description:

Group D: dexamethasone group

Treatment:

Drug: Dexamethasone

Group S

Placebo Comparator group

Description:

Group S: saline group

Treatment:

Drug: saline