NCT02304250

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

1.7 years

First QC Date

November 19, 2014

Last Update Submit

November 25, 2015

Conditions

Wound Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Group D

ACTIVE COMPARATOR

Group D: dexamethasone group

Drug: Dexamethasone

Group S

PLACEBO COMPARATOR

Group S: saline group

Drug: saline

Interventions

DexamethasoneDRUG

dexamethasone 1ml (5mg)

Group D
salineDRUG

saline 1ml

Group S

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective total thyroidectomy or hemithyroidectomy with lymphadenectomy for thyroid cancer

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai 6Th People'S Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Related Publications (1)

  • 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.

    PMID: 30963205DERIVED

MeSH Terms

Conditions

Wound Infection

Interventions

DexamethasoneSodium Chloride

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • WEIPING JIA, Ph.D

    Shanghai Jiao Tong University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 19, 2014

First Posted

December 1, 2014

Study Start

October 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

November 30, 2015

Record last verified: 2015-11

Locations

CN(1)