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

2 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

90

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Airan Liu professor
  • Numer telefonu: 8615295557466
  • E-mail: airanliu@126.com

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: neostigmine injection at the acupoints
Lek: 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.
Aktywny komparator: intramuscular injection of normal saline
Lek: 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.
Aktywny komparator: subcutaneous injection of neostigmine
Lek: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Remission rate of gastrointestinal symptoms within 24 hours
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Śmiertelność na OIT
Ramy czasowe: do 24 miesięcy
wskaźnik przeżycia (przeżycie/ogół) podczas pobytu na OIOM
do 24 miesięcy
28-day mortality
Ramy czasowe: From randomization to Day 28
Mortality was calculated on day 28 of treatment
From randomization to Day 28
Length of ICU stay
Ramy czasowe: up to 28 days
Time of staying in ICU within 28 days
up to 28 days
Infection condition
Ramy czasowe: From randomization to Day 28
Infection condition within 28 days
From randomization to Day 28
28-day vasopressor-free days
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: prior to hospital discharge
Length of hospital stay
prior to hospital discharge
Enteral Nutrition Prescription
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Southeast University, China

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 lutego 2028

Ukończenie studiów (Szacowany)

1 lutego 2028

Daty rejestracji na studia

Pierwszy przesłany

26 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 lipca 2026

Pierwszy wysłany (Rzeczywisty)

9 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

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

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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