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NCT Number: NCT07722091

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

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.

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Key information

About this study

The mechanism of postoperative hoarseness remains unclear. It is traditionally attributed to direct injury to the recurrent laryngeal nerve or to endotracheal intubation. However, the surgical field in upper abdominal procedures is remote from the recurrent laryngeal nerve, yet the incidence of hoarseness is higher than in many other surgeries. Preclinical animal experiments by the research group have demonstrated that electrical or thermal stimulation of the subdiaphragmatic vagal nerve can induce vocal cord paralysis, and that immediate topical spraying of dexamethasone onto the affected area significantly reduces this effect. It is hypothesized that thermal injury to vagal nerve fibers in the upper abdomen triggers aberrant signaling through the solitary nucleus to the nucleus ambiguus, ultimately resulting in dysfunction of the recurrent laryngeal nerve.

This trial is designed as a single-center, prospective, randomized, double-blind, placebo-controlled study. A total of 584 adult patients scheduled for elective gastric, hepatobiliary, or pancreaticoduodenal surgery will be enrolled. At the end of the main surgical procedure and before abdominal closure, the surgeon will spray 10 mg of dexamethasone onto the vagal nerve-rich areas, such as the peritoneum around the esophageal hiatus, the lesser omental sac, and the surface of the hepatoduodenal ligament.

Voice assessments will be conducted daily from postoperative day 1 through day 10 using the GRBAS scale by a trained evaluator blinded to group assignment. Patients will also undergo voice acoustic recording for Praat analysis. Those in the placebo group who develop hoarseness will be re-randomized to receive either intravenous dexamethasone 5 mg or placebo daily for 3 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of postoperative hoarseness within 10 days

    Time frame: Postoperative day 1 to day 10.

    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.

Secondary outcomes

  1. Time to recovery from hoarseness

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

  2. Change in objective voice acoustic parameters measured by Praat software

    Time frame: Postoperative day 1 to day 10.

    Voice samples are recorded using the same professional recording device with the participant producing a sustained vowel /a:/ for at least 5 seconds (sampling rate 44.1 kHz or 48 kHz, mono, WAV format). The recorded samples are analyzed using Praat software (University of Amsterdam) to extract the following parameters: Jitter (local, %), Fundamental Frequency (F0, Hz), and Harmonics-to-Noise Ratio (HNR, dB). The change in each parameter from baseline will be reported for each group.

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

    Time frame: Postoperative day 1 to day 10.

    The GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) scale is a perceptual voice assessment tool. For this study, only the Grade (G) subscore is measured. The G subscore assesses overall hoarseness severity on a 0-3 scale (0=normal, 1=mild, 2=moderate, 3=severe), with higher scores indicating worse voice quality. The G subscore is assessed daily from postoperative day 1 through day 10 and compared between groups to evaluate the trajectory of voice changes. The other four dimensions (R, B, A, S) are not formally scored in this study.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Registry information

Official study title

Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness After Upper Abdominal Surgery: A Prospective Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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