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.
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).
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.
Parallel
Dexamethasone
DrugDexamethasone 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)
Drug10 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.
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.
Time to recovery from hoarseness
Change in objective voice acoustic parameters measured by Praat software
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.
Change in Grade, Roughness, Breathiness, Asthenia, and Strain (GRBAS) scale subscores over time
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.
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Fujian Medical University Union Hospital
Lead sponsor
The Second Affiliated Hospital of Fujian Medical University
Collaborator
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
