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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Recruitment opened Show 5 more changesShow less
    • Trial sites expanded: 0 → 4 locations
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description revised
    • Collaborators expanded, about 23 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07722091
Lead Sponsor Fujian Medical University Union Hospital
Collaborators: The Second Affiliated Hospital of Fujian Medical University, Meng Chao Hepatobiliary Hospital of Fujian Medical University, The First Affiliated Hospital of Nanchang University
Conditions
(from sponsor)
Hoarseness, Post Operative Complicaiton
Related terms Hoarseness
Enrollment 584 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov