Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness After Upper Abdominal Surgery: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 584
- 主要终点
- Incidence of postoperative hoarseness within 10 days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of postoperative hoarseness within 10 days
时间窗: 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.
次要结局
- 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.)
研究者
shikaige
Department of anesthesiology
Fujian Medical University Union Hospital