Study on Neostigmine Acupoint Injection at Zusanli(ST36) for Treating Mechanical Ventilation-Associated Gastrointestinal Dysfunction
A Single-Center,Randomized Controlled Study on Neostigmine Acupoint Injection at Zusanli(ST36) for Treating Mechanical Ventilation-Associated Gastrointestinal Dysfunction
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Airan Liu professor
- Numer telefonu: 8615295557466
- E-mail: airanliu@126.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
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
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: neostigmine injection at the acupoints
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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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Aktywny komparator: intramuscular injection of normal saline
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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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Aktywny komparator: subcutaneous injection of neostigmine
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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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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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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).
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within 24 hours after treatment
|
Miary wyników drugorzędnych
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
|
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28-day mortality
Ramy czasowe: 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
Ramy czasowe: up to 28 days
|
Time of staying in ICU within 28 days
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up to 28 days
|
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Infection condition
Ramy czasowe: From randomization to Day 28
|
Infection condition within 28 days
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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.
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From randomization to Day 28
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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
|
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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.
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before treatment,on day 1 of treatment,on day 3 of treatment,on day 7 of treatment
|
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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.
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before treatment,on day 1 of treatment,on day 3 of treatment
|
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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
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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.
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before treatment,on day 1 of treatment,on day 3 of treatment
|
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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
|
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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
|
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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
|
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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
|
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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.
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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.
|
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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.
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before treatment, on day 1 of treatment, on day 3 of treatment
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Współpracownicy i badacze
Sponsor
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
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)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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