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NCT Number: NCT02304250

Dexamethasone and Wound Healing After 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.

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Key information

Conditions

Wound Infection Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai 6Th People'S Hospital

Shanghai, Shanghai Municipality, 200233, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexamethasone

Drug

dexamethasone 1ml (5mg)

Saline

Drug

saline 1ml

Primary outcomes

  1. the total wound drain after the operation, including the drain in bulb and stain area in dressings,

    Time frame: from postoperative day 0 to postoperative day 4

Secondary outcomes

  1. patient pain scores, including incision pain and throat pain,

    Time frame: from postoperative day 0 to one month after operation

  2. c-reaction protein levels in drainage fluid and blood during perioperative period.

    Time frame: from postoperative day 0 to postoperative day 4

Other outcomes

  1. patient nausea/vomiting scores

    Time frame: from postoperative day 0 to 3 days after operation

  2. other side effects from the surgery

    Time frame: from postoperative day 0 to one month after the operation

Sponsors and collaborators

Lead sponsor

Quanhong Zhou

Other

Registry information

Official study title

The Effect of Dexamethasone on Safety of Thyroid Surgery

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 1, 2014
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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