Study on Neostigmine Acupoint Injection at Zusanli(ST36) for Treating Mechanical Ventilation-Associated Gastrointestinal Dysfunction
2026年7月2日 更新者：Ling Liu、Southeast University, China
A Single-Center,Randomized Controlled Study on Neostigmine Acupoint Injection at Zusanli(ST36) for Treating Mechanical Ventilation-Associated Gastrointestinal Dysfunction
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.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
90
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Airan Liu professor
- 电话号码：8615295557466
- 邮箱：airanliu@126.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：neostigmine injection at the acupoints
|
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.
The intervention period is 1 day, with interventions administered twice daily (bid), 12 hours apart.
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有源比较器：intramuscular injection of normal saline
|
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 period is 1 day, with interventions administered twice daily (bid), 12 hours apart.
|
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有源比较器：subcutaneous injection of neostigmine
|
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Remission rate of gastrointestinal symptoms within 24 hours
大体时间：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).
|
within 24 hours after treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ICU死亡率
大体时间：最长24个月
|
ICU住院期间的存活率（存活人数/总人数）
|
最长24个月
|
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28-day mortality
大体时间：From randomization to Day 28
|
Mortality was calculated on day 28 of treatment
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From randomization to Day 28
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Length of ICU stay
大体时间：up to 28 days
|
Time of staying in ICU within 28 days
|
up to 28 days
|
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Infection condition
大体时间：From randomization to Day 28
|
Infection condition within 28 days
|
From randomization to Day 28
|
|
28-day vasopressor-free days
大体时间：From randomization to Day 28
|
28-day vasopressor-free days is defined as a continuous period of 28 days, beginning from the time a patient is weaned from shock, circulatory failure, or mechanical circulatory support, during which no vasoactive drugs are used at any time, and the patient maintains stable circulation without the need for vasopressors agents to sustain blood pressure and tissue perfusion.
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From randomization to Day 28
|
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28-day ventilator-free days
大体时间：From randomization to Day 28
|
Ventilator-free days are defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization.
|
From randomization to Day 28
|
|
Length of hospital stay
大体时间：prior to hospital discharge
|
Length of hospital stay
|
prior to hospital discharge
|
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Enteral Nutrition Prescription
大体时间：before treatment,on day 1 of treatment,on day 3 of treatment,on day 7 of treatment
|
Enteral Nutrition Prescription was recorded before treatment,on day 1 of treatment,on day 3 of treatment,and on day 7 of treatment.
|
before treatment,on day 1 of treatment,on day 3 of treatment,on day 7 of treatment
|
|
Intra-abdominal pressure(mmHg)
大体时间：before treatment,on day 1 of treatment,on day 3 of treatment
|
The patient was placed in the supine position.
A urinary catheter was inserted transurethrally and connected to a three-way stopcock.
Then 25 mL of 0.9% normal saline was injected.
Taking the level of the pubic symphysis as the zero point, the water column height at the end of expiration was measured and recorded.IAP readings must be converted to mmHg.
|
before treatment,on day 1 of treatment,on day 3 of treatment
|
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Bowel sounds
大体时间：before treatment,on day 1 of treatment,on day 3 of treatment
|
Bowel sounds (times/min) were auscultated daily at a fixed time point before and after treatment over the right lower abdomen with a stethoscope.
Each continuous auscultation lasted 3 minutes; the frequency of bowel sounds per minute was recorded, and the mean value of three repeated measurements was calculated.
|
before treatment,on day 1 of treatment,on day 3 of treatment
|
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motilin
大体时间：before treatment,on day 1 of treatment,on day 3 of treatment
|
Venous blood samples of 2 mL were collected in the early morning before treatment, on day 1 and day 3 after treatment.
The levels of motilin (MTL) were determined and recorded.
|
before treatment,on day 1 of treatment,on day 3 of treatment
|
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gastrin
大体时间：before treatment,on day 1 of treatment,on day 3 of treatment
|
Venous blood samples of 2 mL were collected in the early morning before treatment, on day 1 and day 3 after treatment.
The levels of gastrin (GAS) were determined and recorded.
|
before treatment,on day 1 of treatment,on day 3 of treatment
|
|
vasoactive intestinal peptide
大体时间：before treatment,on day 1 of treatment,on day 3 of treatment
|
Venous blood samples of 2 mL were collected in the early morning before treatment, on day 1 and day 3 after treatment.
The levels of vasoactive intestinal peptide (VIP) were determined and recorded.
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before treatment,on day 1 of treatment,on day 3 of treatment
|
|
electrogastroenterography changes:FP(cpm)
大体时间：before treatment,on day 1 of treatment,on day 3 of treatment
|
An electrogastroenterograph (Model EGEG-8D) was adopted.
During examination, all subjects were placed in the supine position.
Electrogastroenterography was performed before treatment, at 1 day and 3 days after treatment, and the main frequency (FP) (cpm) were recorded.
|
before treatment,on day 1 of treatment,on day 3 of treatment
|
|
hemoglobin
大体时间：before treatment,on day 1 of treatment,on day 3 of treatment
|
Hemoglobin(g/L) are measured at baseline ,Day1, and Day3 as a marker of nutritional condition.
|
before treatment,on day 1 of treatment,on day 3 of treatment
|
|
albumin
大体时间：before treatment,on day 1 of treatment,on day 3 of treatment
|
Serum albumin levels(g/L) are measured at baseline ,Day1, and Day3 as a marker of nutritional condition.
|
before treatment,on day 1 of treatment,on day 3 of treatment
|
|
prealbumin
大体时间：before treatment,on day 1 of treatment,on day 3 of treatment
|
Serum prealbumin levels(mg/L) are measured at baseline ,Day1, and Day3 as a marker of nutritional condition.
|
before treatment,on day 1 of treatment,on day 3 of treatment
|
|
White blood cell count
大体时间：before treatment, on day 1 of treatment, on day 3 of treatment
|
Serum White blood cell count (10^9/L) is measured at baseline ,Day1, and Day3 as a marker of a systemic inflammatory response.
|
before treatment, on day 1 of treatment, on day 3 of treatment
|
|
Lymphocyte count
大体时间：before treatment, on day 1 of treatment, on day 3 of treatment
|
Serum lymphocyte count (10^9/L) is measured at baseline ,Day1, and Day3 as a marker of a systemic inflammatory response.
|
before treatment, on day 1 of treatment, on day 3 of treatment
|
|
C-reactive protein
大体时间：before treatment, on day 1 of treatment, on day 3 of treatment
|
Serum C-reactive protein levels(mg/L) are measured at baseline ,Day1, and Day3 as a marker of a systemic inflammatory response.
|
before treatment, on day 1 of treatment, on day 3 of treatment
|
|
Procalcitonin
大体时间：before treatment, on day 1 of treatment, on day 3 of treatment
|
Serum procalcitonin protein levels(ng/mL) are measured at baseline ,Day1, and Day3 as a marker of a systemic inflammatory response.
|
before treatment, on day 1 of treatment, on day 3 of treatment
|
|
electrogastroenterography changes:FC(cpm)
大体时间：before treatment, on day 1 of treatment, on day 3 of treatment
|
An electrogastroenterograph (Model EGEG-8D) was adopted.
During examination, all subjects were placed in the supine position.
Electrogastroenterography was performed before treatment, at 1 day and 3 days after treatment, and the mean frequency (FC) were recorded.
|
before treatment, on day 1 of treatment, on day 3 of treatment
|
|
electrogastroenterography changes:AP(uV)
大体时间：before treatment, on day 1 of treatment, on day 3 of treatment
|
An electrogastroenterograph (Model EGEG-8D) was adopted.
During examination, all subjects were placed in the supine position.
Electrogastroenterography was performed before treatment, at 1 day and 3 days after treatment, and amplitude was recorded.
|
before treatment, on day 1 of treatment, on day 3 of treatment
|
|
Actual feeding amount
大体时间：before treatment, on day 1 of treatment, on day 3 of treatment, on day 7 of treatment.
|
Actual feeding amount (kcal)was recorded before treatment, on day 1 of treatment, on day 3 of treatment, on day 7 of treatment.
|
before treatment, on day 1 of treatment, on day 3 of treatment, on day 7 of treatment.
|
|
Intestinal diameter
大体时间：before treatment, on day 1 of treatment, on day 3 of treatment
|
Using a Philips ultrasound machine, the intestinal diameter（cm） was assessed by scanning with a convex probe while the patient was in the supine position before treatment, 1 day after treatment, and 3 days after treatment.
|
before treatment, on day 1 of treatment, on day 3 of treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2028年2月1日
研究完成 (估计的)
2028年2月1日
研究注册日期
首次提交
2026年6月26日
首先提交符合 QC 标准的
2026年7月2日
首次发布 (实际的)
2026年7月9日
研究记录更新
最后更新发布 (实际的)
2026年7月9日
上次提交的符合 QC 标准的更新
2026年7月2日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- ST36 Acupoint injection
- 2026ZDSYLL103-P01 (其他标识符：Zhongda Hospital Affiliated to Southeast University)
计划个人参与者数据 (IPD)
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药物和器械信息、研究文件
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不
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