Spraying dexamethasone on vagal nerve–rich areas during abdominal surgery to prevent hoarseness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, prospective, randomized, double-blind, placebo-controlled trial enrolling up to 584 adults undergoing gastric, hepatobiliary, or pancreaticoduodenal surgery. Participants are randomly assigned to receive intraoperative spraying of 10 mg dexamethasone in 10 mL saline or 10 mL saline as a placebo onto vagal nerve–rich areas before closing the abdomen. Postoperative voice assessments are performed daily for 10 days using the GRBAS scale, starting on day 1. If hoarseness occurs, a separate question will evaluate whether intravenous dexamethasone aids recovery. The trial aims to clarify whether topical dexamethasone can reduce the incidence of postoperative hoarseness and whether additional systemic therapy accelerates recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 to 75 years, both sexes.
* Elective abdominal surgery (including gastric, hepatobiliary, and pancreaticoduodenal surgery) under general anesthesia.
* American Society of Anesthesiologists (ASA) physical status classification I-III.
* Preoperative GRBAS Grade (G) score = 0 (no hoarseness).
* Signed written informed consent.

Exclusion Criteria:

* Need for systemic glucocorticoid therapy during hospitalization for other reasons.
* Pre-existing hoarseness, vocal cord paralysis, or organic vocal cord lesions.
* History of neck surgery, neck radiotherapy, or laryngeal surgery.
* Known allergy to dexamethasone or other glucocorticoids.
* Active peptic ulcer or gastrointestinal bleeding within 6 months prior to enrollment.
* Uncontrolled diabetes mellitus or severe active infection.

Where it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• Mengchao Hepatobiliary Hospital of Fujian Medical University
  Fuzhou, Fujian, China Not yet recruiting
• The Second Affiliated Hospital of Fujian Medical University
  Quanzhou, Fujian, China Not yet recruiting
• The First Affiliated Hospital of Nanchang University
  Nanchang, Jiangxi, China Not yet recruiting

Study contacts

• Principal investigator: Zhongmeng Lai — Fujian Medical University Union Hospital
• Study coordinator: Kaige Shi
• Email: shikg2001@163.com
• Phone: +86-18259992395

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.