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

NCT07722091 | Not Yet Recruiting

• 1 other identifier: 2026KY683
• Study Type: interventional
• Target: 584
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hoarseness; Post Operative Complicaiton

Keywords

Dexamethasone; Postoperative Hoarseness; Upper Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative hoarseness within 10 days

  The proportion of patients with a GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) Grade (G) score ≥ 2 at any time point from postoperative day 1 to day 10.

  Postoperative day 1 to day 10.

Secondary Outcomes (3)

• Time to recovery from hoarseness

  From first diagnosis of hoarseness (GRBAS G ≥2) to recovery of voice (GRBAS G <2), assessed up to postoperative day 10.

• Change in objective voice acoustic parameters measured by Praat software

  Postoperative day 1 to day 10.

• Change in Grade, Roughness, Breathiness, Asthenia, and Strain (GRBAS) scale subscores over time

  Postoperative day 1 to day 10.

Study Arms (2)

Dexamethasone Prophylaxis Group

EXPERIMENTAL

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 Group

PLACEBO 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)

Interventions

Dexamethasone DRUG

Dexamethasone 10 mg diluted in 10 mL normal saline, sprayed topically onto the vagal nerve-rich areas (esophageal hiatus, lesser omental sac, hepatoduodenal ligament) once at the end of surgery before abdominal closure.

Dexamethasone Prophylaxis Group

Saline (0.9% NaCl) DRUG

10 mL normal saline sprayed topically onto the same vagal nerve-rich areas once at the end of surgery before abdominal closure. Patients in the placebo group who develop hoarseness (GRBAS Grade ≥ 2) will be re-randomized to receive intravenous dexamethasone 5 mg daily or placebo for 3 days.

Placebo Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

MeSH Terms

Conditions

Hoarseness

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• ZHONGMENG LAI

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KAIGE SHI

CONTACT

+86-18259992395; shikg2001@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of anesthesiology

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 23, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share