Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness After Upper Abdominal Surgery

Starting soon · Not applicable · Has a placebo group

Conditions studied: Hoarseness, Post Operative Complicaiton

In brief

The goal of this clinical trial is to evaluate whether intraoperative spraying of dexamethasone onto the abdominal vagal nerve-rich areas can prevent postoperative hoarseness in patients undergoing elective upper abdominal surgery. The main questions it aims to answer are: * Does intraoperative topical dexamethasone spraying reduce the incidence of postoperative hoarseness after upper abdominal surgery? * Does postoperative intravenous dexamethasone accelerate recovery in patients who develop hoarseness? Researchers will compare a dexamethasone group (intraoperative spraying of 10 mg dexamethasone in 10 mL normal saline) to a placebo group (intraoperative spraying of 10 mL normal saline alone) to see if dexamethasone reduces the rate of postoperative hoarseness. Participants will: * Undergo voice assessment (GRBAS scale) and voice recording before surgery and daily for 10 days after surgery. * Be randomly assigned to receive either dexamethasone or placebo sprayed onto the surgical field at the end of the operation. * If hoarseness develops in the placebo group, be randomly assigned again to receive either intravenous dexamethasone (5 mg daily for 3 days) or placebo.

Key facts

Study ID

NCT07722091

Run by

Fujian Medical University Union Hospital

People needed

584

Starts

2026-07-27

Expected to finish

2027-03-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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