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RECRUITING
NCT07722091
NA

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

Sponsor: Fujian Medical University Union Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness After Upper Abdominal Surgery: A Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

584

Start Date

2026-07-27

Completion Date

2027-03-01

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

DRUG

Dexamethasone

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.

DRUG

Saline (0.9% NaCl)

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.

Locations (4)

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