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NCT Number: NCT07692282

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.

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Key information

Conditions

Gastrointestinal Dysfunction

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neostigmine Acupoint Injection

Drug

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.

Neostigmine subcutaneous injection

Drug

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.

Acupoint normal saline injection

Drug

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.

Primary outcomes

  1. Remission rate of gastrointestinal symptoms within 24 hours

    Time frame: 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).

Secondary outcomes

  1. 28-day mortality

    Time frame: From randomization to Day 28

    Mortality was calculated on day 28 of treatment

  2. ICU mortality

    Time frame: up to 24 months

    the survival rate(survival/total) during ICU stay

  3. Length of ICU stay

    Time frame: up to 28 days

    Time of staying in ICU within 28 days

  4. Infection condition

    Time frame: From randomization to Day 28

    Infection condition within 28 days

  5. 28-day vasopressor-free days

    Time frame: 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.

  6. 28-day ventilator-free days

    Time frame: 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.

  7. Length of hospital stay

    Time frame: prior to hospital discharge

    Length of hospital stay

  8. Enteral Nutrition Prescription

    Time frame: 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.

  9. Intra-abdominal pressure(mmHg)

    Time frame: 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.

  10. Bowel sounds

    Time frame: 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.

  11. motilin

    Time frame: 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.

  12. gastrin

    Time frame: 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.

  13. vasoactive intestinal peptide

    Time frame: 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.

  14. electrogastroenterography changes:FP(cpm)

    Time frame: 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.

  15. hemoglobin

    Time frame: 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.

  16. albumin

    Time frame: 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.

  17. prealbumin

    Time frame: 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.

  18. White blood cell count

    Time frame: 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.

  19. Lymphocyte count

    Time frame: 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.

  20. C-reactive protein

    Time frame: 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.

  21. Procalcitonin

    Time frame: 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.

  22. electrogastroenterography changes:FC(cpm)

    Time frame: 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.

  23. electrogastroenterography changes:AP(uV)

    Time frame: 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.

  24. Actual feeding amount

    Time frame: 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.

  25. Intestinal diameter

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Airan Liu professor

CONTACT

[email protected]

8615295557466

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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