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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02304250
Other study ID # 2014-50
Secondary ID
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


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
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