Dexamethasone and Wound Healing After Thyroid Surgery

The Effect of Dexamethasone on Safety of Thyroid Surgery

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.

Study Overview

• Status: Completed
• Conditions: Wound Infection
• Intervention / Treatment: Drug: Dexamethasone; Drug: saline

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 Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200233
      • Shanghai 6th People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group D; Group D: dexamethasone group	Drug: Dexamethasone; dexamethasone 1ml (5mg)
Placebo Comparator: Group S; Group S: saline group	Drug: saline; saline 1ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 Outcome Measures

Outcome Measure	Time 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 Outcome Measures

Outcome Measure	Time Frame
patient nausea/vomiting scores	from postoperative day 0 to 3 days after operation
other side effects from the surgery	from postoperative day 0 to one month after the operation

Collaborators and Investigators

• Sponsor: Quanhong Zhou
• Investigators: Study Chair: WEIPING JIA, Ph.D, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

General Publications

• Zhang H, Lu J, Wu Q, Wu B, Xu C, Fan Y, Zhou Q. A Perioperative Small Dose of Dexamethasone Enhances Postoperative Recovery by Reducing Volume and Inflammatory Contents in Wound Drainage After Thyroid Surgery: A Double-Blinded, Randomized, Prospective Study. World J Surg. 2019 Jul;43(7):1721-1727. doi: 10.1007/s00268-019-04986-0.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: November 19, 2014
• First Submitted That Met QC Criteria: November 25, 2014
• First Posted (Estimate): December 1, 2014

Study Record Updates

• Last Update Posted (Estimate): November 30, 2015
• Last Update Submitted That Met QC Criteria: November 25, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Wound Infection; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 2014-50