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Clinical Trials/NCT02304250
NCT02304250
Completed
Not Applicable

The Effect of Dexamethasone on Safety of Thyroid Surgery

Quanhong Zhou1 site in 1 country220 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
saline
Conditions
Wound Infection
Sponsor
Quanhong Zhou
Enrollment
220
Locations
1
Primary Endpoint
the total wound drain after the operation, including the drain in bulb and stain area in dressings,
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
July 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Quanhong Zhou
Responsible Party
Sponsor Investigator
Principal Investigator

Quanhong Zhou

Doctor

Shanghai 6th People's Hospital

Eligibility Criteria

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)

Arms & Interventions

Group S

Group S: saline group

Intervention: saline

Group D

Group D: dexamethasone group

Intervention: Dexamethasone

Outcomes

Primary Outcomes

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

  • 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)

Study Sites (1)

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