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NCT07722091
Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness After Upper Abdominal Surgery
Conditions: Hoarseness, Post Operative Complicaiton
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 584
Sponsor: Fujian Medical University Union Hospital
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.
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.
Source: ClinicalTrials.gov (NCT07722091). StuddyBuddy aggregates publicly available trial information.