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Dexamethasone and Wound Healing After Thyroid Surgery

The Effect of Dexamethasone on Safety of Thyroid Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02304250
Enrollment
220
Registered
2014-12-01
Start date
2013-10-31
Completion date
2015-07-31
Last updated
2015-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Infection

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.

Interventions

DRUGDexamethasone

dexamethasone 1ml (5mg)

DRUGsaline

saline 1ml

Sponsors

Quanhong Zhou
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Other

MeasureTime frame
patient nausea/vomiting scoresfrom postoperative day 0 to 3 days after operation
other side effects from the surgeryfrom postoperative day 0 to one month after the operation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026