Study on Neostigmine Acupoint Injection at Zusanli(ST36) for Treating Mechanical Ventilation-Associated Gastrointestinal Dysfunction

Официальное название

A Single-Center,Randomized Controlled Study on Neostigmine Acupoint Injection at Zusanli(ST36) for Treating Mechanical Ventilation-Associated Gastrointestinal Dysfunction

Обзор

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.

Вмешательства

• Препарат Neostigmine Acupoint Injection
  On the basis of standard treatment, neostigmine was injected into the bilateral Zusanli (ST36) acupoints. The patient was placed in the supine position with knees flexed. Following routine local disinfection, a 5 mL disposable syringe was used to extract 0.5 mg of neostigmine for vertical subcutaneous needling and injection. Upon needle withdrawal, the puncture site was compressed with sterile cotton swabs for hemostasis. The identical procedure was applied to the contralateral Zusanli acupoint.
• Препарат Neostigmine subcutaneous injection
  On the basis of standard treatment, subcutaneous injection was performed at non-acupoint sites. A 5 mL disposable syringe was used to aspirate 1 mg of neostigmine injection for single-site injection. The injection site received routine disinfection beforehand. Following the injection, the needle was withdrawn, and the puncture site was compressed with sterile cotton swabs for hemostasis.The intervention period is 1 day, with interventions administered twice daily (bid), 12 hours apart.
• Препарат Acupoint normal saline injection
  On the basis of standard treatment, normal saline was injected into bilateral Zusanli (ST36) acupoints. The patient was placed in the supine position with knees flexed. After routine local disinfection, a 5 mL disposable syringe was used for vertical needle insertion, and an equal volume of normal saline was injected subcutaneously into each acupoint. Following injection, the needle was withdrawn, and the puncture site was compressed with sterile cotton swabs for hemostasis.The intervention peri

Первичные конечные точки

• Remission rate of gastrointestinal symptoms within 24 hours [Срок оценки: within 24 hours after treatment]

Вторичные конечные точки (12)

• 28-day mortality [Срок оценки: From randomization to Day 28]
• ICU mortality [Срок оценки: up to 24 months]
• Length of ICU stay [Срок оценки: up to 28 days]
• Infection condition [Срок оценки: From randomization to Day 28]
• 28-day vasopressor-free days [Срок оценки: From randomization to Day 28]
• 28-day ventilator-free days [Срок оценки: From randomization to Day 28]
• Length of hospital stay [Срок оценки: prior to hospital discharge]
• Enteral Nutrition Prescription [Срок оценки: before treatment,on day 1 of treatment,on day 3 of treatment,on day 7 of treatment]
• Intra-abdominal pressure(mmHg) [Срок оценки: before treatment,on day 1 of treatment,on day 3 of treatment]
• Bowel sounds [Срок оценки: before treatment,on day 1 of treatment,on day 3 of treatment]
• motilin [Срок оценки: before treatment,on day 1 of treatment,on day 3 of treatment]
• gastrin [Срок оценки: before treatment,on day 1 of treatment,on day 3 of treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07692282 · ST36 Acupoint injection · 2026ZDSYLL103-P01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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