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

RecruitingNAAges 18 Years - 75 YearsAllFujian Medical University Union Hospital
NCT07722091 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 s

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📋 Eligibility rules (as published)
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.
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What it tests

  • Dexamethasone
  • Saline (0.9% NaCl)
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Where

4 sites
Fujian Medical University Union Hospital
Fuzhou, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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