MedDataX Logo

Dexamethasone and Wound Healing After Thyroid Surgery

NCT ID: NCT02304250

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wound Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group D

Group D: dexamethasone group

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

dexamethasone 1ml (5mg)

Group S

Group S: saline group

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

saline 1ml

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexamethasone

dexamethasone 1ml (5mg)

Intervention Type DRUG

saline

saline 1ml

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Quanhong Zhou

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Quanhong Zhou

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

WEIPING JIA, Ph.D

Role: STUDY_CHAIR

Shanghai Jiao Tong University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai 6Th People'S Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30963205 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-50

Identifier Type: -

Identifier Source: org_study_id