A Single-Center,Randomized Controlled Study on Neostigmine Acupoint Injection at Zusanli(ST36) for Treating Mechanical Ventilation-Associated Gastrointestinal Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Remission rate of gastrointestinal symptoms within 24 hours
研究概览
简要总结
Mechanical ventilation is a common method of respiratory support for critically ill patients, and gastrointestinal dysfunction (GIDF) is a frequent complication. In the ICU, more than 60% of mechanically ventilated patients experience gastrointestinal dysfunction. Currently, the exact causes of mechanical ventilation-induced gastrointestinal dysfunction remain unclear, but they primarily include increased intra-abdominal pressure resulting from positive-pressure ventilation, which inhibits gastrointestinal motility; inflammatory responses, prolonged bed rest, electrolyte imbalances, and the use of sedatives, analgesics, and even muscle relaxants . Manifestations such as gastroparesis and constipation further lead to delayed gastric emptying, increased intra-abdominal pressure, and heightened risks of bacterial translocation, multiple organ failure, and ventilator-associated pneumonia. Primary Objective is to investigate, through a prospective randomized controlled trial, the efficacy of neostigmine injection at the Zusanli acupoint compared to Zusanli acupoint stimulation alone or subcutaneous neostigmine injection in improving gastrointestinal function in patients with mechanical ventilation and gastrointestinal dysfunction. Secondary objectives: （1）To evaluate the effects of acupoint injection of neostigmine on the duration of mechanical ventilation, enteral nutrition intake, and ICU length of stay in critically ill patients; （2）To assess the safety of acupoint injection of neostigmine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Respiratory failure due to any cause requiring mechanical ventilation, with an anticipated duration of mechanical ventilation of ≥48 hours;
- •No spontaneous bowel movements for ≥48 hours or increased gastric residual volume (gastric residual volume >500 mL within 24 hours);
- •Anticipated ICU stay of ≥3 days;
- •Age ≥18 years and ≤85 years.
排除标准
- •Use of prokinetic agents, subcutaneous or acupoint injections of neostigmine, or acupuncture at the Zusanli acupoint within 12 hours prior to enrollment;
- •History of gastrointestinal surgery within the past 8 weeks; diarrhea within the past week; or history of severe gastrointestinal diseases such as mechanical intestinal obstruction, intestinal ischemia and necrosis, inflammatory bowel disease, or active gastrointestinal bleeding;
- •Patients with an allergy to neostigmine or contraindications to its use, such as mechanical intestinal obstruction, urinary tract obstruction, bronchial asthma, bradycardia, hypotension, epilepsy, or Parkinson's disease;
- •Patients unable to undergo acupoint injection due to skin lesions, infection, limb loss, or inability to cooperate at the Zusanli acupoint;
- •Patients currently requiring routine treatment with neostigmine or similar cholinesterase inhibitors for other indications (e.g., myasthenia gravis, multiple sclerosis, Parkinson's disease);
- •Patients with a platelet count <50 × 10⁹/L on complete blood count or severe coagulation disorders (International Normalized Ratio [INR] >3);
- •Severe hepatic impairment (Child-Pugh Class C) or hepatic encephalopathy;
- •End-stage renal failure requiring dialysis prior to admission;
- •Patients with hemodynamic instability (norepinephrine equivalent > 1.0 μg/kg·min);
- •Patients who have participated in other interventional clinical trials within the past month;
- •Pregnant, perinatal, or lactating women.
结局指标
主要结局
Remission rate of gastrointestinal symptoms within 24 hours
时间窗: within 24 hours after treatment
Gastrointestinal symptom relief is defined as meeting both recovery of spontaneous defecation (i.e., the first defecation after initial intervention with a defecation volume \> 100 mL) and improvement in 24-hour gastric retention (24-hour gastric retention volume ≤ 500 mL).
次要结局
- 28-day mortality(From randomization to Day 28)
- ICU mortality(up to 24 months)
- Length of ICU stay(up to 28 days)
- Infection condition(From randomization to Day 28)
- 28-day vasopressor-free days(From randomization to Day 28)
- 28-day ventilator-free days(From randomization to Day 28)
- Length of hospital stay(prior to hospital discharge)
- Enteral Nutrition Prescription(before treatment,on day 1 of treatment,on day 3 of treatment,on day 7 of treatment)
- Intra-abdominal pressure(mmHg)(before treatment,on day 1 of treatment,on day 3 of treatment)
- Bowel sounds(before treatment,on day 1 of treatment,on day 3 of treatment)
- motilin(before treatment,on day 1 of treatment,on day 3 of treatment)
- gastrin(before treatment,on day 1 of treatment,on day 3 of treatment)
- vasoactive intestinal peptide(before treatment,on day 1 of treatment,on day 3 of treatment)
- electrogastroenterography changes:FP(cpm)(before treatment,on day 1 of treatment,on day 3 of treatment)
- hemoglobin(before treatment,on day 1 of treatment,on day 3 of treatment)
- albumin(before treatment,on day 1 of treatment,on day 3 of treatment)
- prealbumin(before treatment,on day 1 of treatment,on day 3 of treatment)
- White blood cell count(before treatment, on day 1 of treatment, on day 3 of treatment)
- Lymphocyte count(before treatment, on day 1 of treatment, on day 3 of treatment)
- C-reactive protein(before treatment, on day 1 of treatment, on day 3 of treatment)
- Procalcitonin(before treatment, on day 1 of treatment, on day 3 of treatment)
- electrogastroenterography changes:FC(cpm)(before treatment, on day 1 of treatment, on day 3 of treatment)
- electrogastroenterography changes:AP(uV)(before treatment, on day 1 of treatment, on day 3 of treatment)
- Actual feeding amount(before treatment, on day 1 of treatment, on day 3 of treatment, on day 7 of treatment.)
- Intestinal diameter(before treatment, on day 1 of treatment, on day 3 of treatment)
研究者
Ling Liu
Professor
Southeast University, China