Dexamethasone and Wound Healing After Thyroid Surgery

Wound Infection Clinical Trial

Official title:

The Effect of Dexamethasone on Safety of Thyroid Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304250
• Other study ID #: 2014-50
• Status: Completed
• Phase: N/A
• First received: November 19, 2014
• Last updated: November 25, 2015
• Start date: October 2013
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: Shanghai 6th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Wound Infection

Intervention

Drug:
• Dexamethasone
dexamethasone 1ml (5mg)
• saline
saline 1ml

Locations

Country	Name	City	State
China	Shanghai 6Th People'S Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Quanhong Zhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patient nausea/vomiting scores		from postoperative day 0 to 3 days after operation	No
Other	other side effects from the surgery		from postoperative day 0 to one month after the operation	No
Primary	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	No
Secondary	patient pain scores, including incision pain and throat pain,		from postoperative day 0 to one month after operation	No
Secondary	c-reaction protein levels in drainage fluid and blood during perioperative period.		from postoperative day 0 to postoperative day 4	No