Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness Aft… (NCT07722091) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness After Upper Abdominal Surgery
584 participantsStarted 2026-07-27
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of postoperative hoarseness within 10 days