Study on Neostigmine Acupoint Injection at Zusanli(ST36) for Treating Mechanical Ventilation-Associated Gastrointestinal Dysfunction
2 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Studietype
Ingrijpend
Inschrijving (Geschat)
90
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Airan Liu professor
- Telefoonnummer: 8615295557466
- E-mail: airanliu@126.com
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Actieve vergelijker: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Remission rate of gastrointestinal symptoms within 24 hours
Tijdsspanne: within 24 hours after treatment
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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IC-mortaliteit
Tijdsspanne: tot 24 maanden
|
het overlevingspercentage (overleving/totaal) tijdens het verblijf op de IC
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tot 24 maanden
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28-day mortality
Tijdsspanne: From randomization to Day 28
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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
Tijdsspanne: up to 28 days
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Time of staying in ICU within 28 days
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up to 28 days
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Infection condition
Tijdsspanne: From randomization to Day 28
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Infection condition within 28 days
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From randomization to Day 28
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28-day vasopressor-free days
Tijdsspanne: 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
Tijdsspanne: From randomization to Day 28
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Ventilator-free days are defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization.
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From randomization to Day 28
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Length of hospital stay
Tijdsspanne: prior to hospital discharge
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Length of hospital stay
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prior to hospital discharge
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Enteral Nutrition Prescription
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: before treatment,on day 1 of treatment,on day 3 of treatment
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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.
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before treatment,on day 1 of treatment,on day 3 of treatment
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motilin
Tijdsspanne: before treatment,on day 1 of treatment,on day 3 of treatment
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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
Tijdsspanne: 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.
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before treatment,on day 1 of treatment,on day 3 of treatment
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vasoactive intestinal peptide
Tijdsspanne: 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
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electrogastroenterography changes:FP(cpm)
Tijdsspanne: 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.
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before treatment,on day 1 of treatment,on day 3 of treatment
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hemoglobin
Tijdsspanne: before treatment,on day 1 of treatment,on day 3 of treatment
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Hemoglobin(g/L) are measured at baseline ,Day1, and Day3 as a marker of nutritional condition.
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before treatment,on day 1 of treatment,on day 3 of treatment
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albumin
Tijdsspanne: before treatment,on day 1 of treatment,on day 3 of treatment
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Serum albumin levels(g/L) are measured at baseline ,Day1, and Day3 as a marker of nutritional condition.
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before treatment,on day 1 of treatment,on day 3 of treatment
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prealbumin
Tijdsspanne: before treatment,on day 1 of treatment,on day 3 of treatment
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Serum prealbumin levels(mg/L) are measured at baseline ,Day1, and Day3 as a marker of nutritional condition.
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before treatment,on day 1 of treatment,on day 3 of treatment
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White blood cell count
Tijdsspanne: before treatment, on day 1 of treatment, on day 3 of treatment
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Serum White blood cell count (10^9/L) is measured at baseline ,Day1, and Day3 as a marker of a systemic inflammatory response.
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before treatment, on day 1 of treatment, on day 3 of treatment
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Lymphocyte count
Tijdsspanne: 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.
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before treatment, on day 1 of treatment, on day 3 of treatment
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C-reactive protein
Tijdsspanne: 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.
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before treatment, on day 1 of treatment, on day 3 of treatment
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Procalcitonin
Tijdsspanne: 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.
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before treatment, on day 1 of treatment, on day 3 of treatment
|
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electrogastroenterography changes:FC(cpm)
Tijdsspanne: 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.
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before treatment, on day 1 of treatment, on day 3 of treatment
|
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electrogastroenterography changes:AP(uV)
Tijdsspanne: 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.
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before treatment, on day 1 of treatment, on day 3 of treatment
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Actual feeding amount
Tijdsspanne: 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.
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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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Intestinal diameter
Tijdsspanne: before treatment, on day 1 of treatment, on day 3 of treatment
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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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Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 juli 2026
Primaire voltooiing (Geschat)
1 februari 2028
Studie voltooiing (Geschat)
1 februari 2028
Studieregistratiedata
Eerst ingediend
26 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
2 juli 2026
Eerst geplaatst (Werkelijk)
9 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
2 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- ST36 Acupoint injection
- 2026ZDSYLL103-P01 (Andere identificatie: Zhongda Hospital Affiliated to Southeast University)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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