Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness After Upper Abdominal Surgery | NCT07722091

NCT07722091

Overview

NCT ID: NCT07722091
Lead Sponsor: Fujian Medical University Union HospitalOTHER
Official Title: Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness After Upper Abdominal Surgery: A Prospective Randomized Controlled Trial
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 23, 2026Actual
Start Date: Jul 27, 2026Estimated
Primary Completion Date: Jan 30, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 584Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: KAIGE SHIContact
shikg2001@163.com+86-18259992395

Similar Studies

Participant Group/Arms

Dexamethasone Prophylaxis GroupExperimental

At the end of surgery before abdominal closure, 10 mg dexamethasone diluted in 10 mL normal saline is sprayed onto the vagal nerve-rich areas: peritoneum around the esophageal hiatus, lesser omental sac, and surface of the hepatoduodenal ligament. Voice assessed daily (GRBAS scale + Praat recording) from postoperative day 1-10.

Drug: Dexamethasone

Placebo Control GroupPlacebo Comparator

At the end of surgery before abdominal closure, 10 mL normal saline alone is sprayed onto the same vagal nerve-rich areas. Voice assessed daily (GRBAS scale + Praat recording) from postoperative day 1-10. Patients who develop hoarseness (GRBAS Grade ≥2) are re-randomized to receive intravenous dexamethasone 5 mg or placebo daily for 3 days.

Drug: Saline (0.9% NaCl)