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

Condition(s) studied

Investigational drug(s) / intervention(s)

Dexamethasone: 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): 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Incidence of postoperative hoarseness within 10 days — 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.

Trial sites (4)

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