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

2. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

90

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Airan Liu professor
  • Telefonní číslo: 8615295557466
  • E-mail: airanliu@126.com

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: neostigmine injection at the acupoints
Lék: 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. The intervention period is 1 day, with interventions administered twice daily (bid), 12 hours apart.
Aktivní komparátor: intramuscular injection of normal saline
Lék: 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 period is 1 day, with interventions administered twice daily (bid), 12 hours apart.
Aktivní komparátor: subcutaneous injection of neostigmine
Lék: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Remission rate of gastrointestinal symptoms within 24 hours
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Úmrtnost na JIP
Časové okno: až 24 měsíců
přežití (přežití/celkem) během pobytu na JIP
až 24 měsíců
28-day mortality
Časové okno: From randomization to Day 28
Mortality was calculated on day 28 of treatment
From randomization to Day 28
Length of ICU stay
Časové okno: up to 28 days
Time of staying in ICU within 28 days
up to 28 days
Infection condition
Časové okno: From randomization to Day 28
Infection condition within 28 days
From randomization to Day 28
28-day vasopressor-free days
Časové okno: 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.
From randomization to Day 28
28-day ventilator-free days
Časové okno: 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
Časové okno: prior to hospital discharge
Length of hospital stay
prior to hospital discharge
Enteral Nutrition Prescription
Časové okno: 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)
Časové okno: 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
Bowel sounds
Časové okno: 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
motilin
Časové okno: 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
gastrin
Časové okno: 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
Časové okno: 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.
before treatment,on day 1 of treatment,on day 3 of treatment
electrogastroenterography changes:FP(cpm)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Southeast University, China

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. února 2028

Dokončení studie (Odhadovaný)

1. února 2028

Termíny zápisu do studia

První předloženo

26. června 2026

První předloženo, které splnilo kritéria kontroly kvality

2. července 2026

První zveřejněno (Aktuální)

9. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • ST36 Acupoint injection
  • 2026ZDSYLL103-P01 (Jiný identifikátor: Zhongda Hospital Affiliated to Southeast University)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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