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

Sponsor: Fujian Medical University Union Hospital • ClinicalTrials.gov ID: NCT07722091

Registry updated: 2026-09-23

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Description

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.

Interventions

Dexamethasone (Drug)
Dexamethasone 10 mg diluted in 10 mL normal saline, sprayed topically onto the vagal nerve-rich areas (esophageal hiatus, lesser omental sac, hepatoduodenal ligament) once at the end of surgery before abdominal closure.
Saline (0.9% NaCl) (Drug)
10 mL normal saline sprayed topically onto the same vagal nerve-rich areas once at the end of surgery before abdominal closure. Patients in the placebo group who develop hoarseness (GRBAS Grade ≥ 2) will be re-randomized to receive intravenous dexamethasone 5 mg daily or placebo for 3 days.

Eligibility criteria

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.

Conditions

Hoarseness Post Operative Complicaiton

Locations

Fujian Medical University Union Hospital — Fuzhou, Fujian, China
Mengchao Hepatobiliary Hospital of Fujian Medical University — Fuzhou, Fujian, China
The Second Affiliated Hospital of Fujian Medical University — Quanzhou, Fujian, China
The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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