Study on Neostigmine Acupoint Injection at Zusanli(ST36) for Treating Mechanical Ventilation-Associated Gastrointestinal Dysfunction
2 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
90
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Airan Liu professor
- Telefonnummer: 8615295557466
- E-post: airanliu@126.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Aktiv 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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Aktiv 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Remission rate of gastrointestinal symptoms within 24 hours
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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ICU-mortalitet
Tidsram: upp till 24 månader
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överlevnadsgraden (överlevnad/total) under intensivvårdsvistelsen
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upp till 24 månader
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28-day mortality
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: From randomization to Day 28
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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
Tidsram: 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
Tidsram: 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
Tidsram: before treatment,on day 1 of treatment,on day 3 of treatment,on day 7 of treatment
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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)
Tidsram: before treatment,on day 1 of treatment,on day 3 of treatment
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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
Tidsram: 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
Tidsram: 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
Tidsram: 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 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
Tidsram: 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 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)
Tidsram: before treatment,on day 1 of treatment,on day 3 of treatment
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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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: before treatment, on day 1 of treatment, on day 3 of treatment
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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
Tidsram: before treatment, on day 1 of treatment, on day 3 of treatment
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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
Tidsram: before treatment, on day 1 of treatment, on day 3 of treatment
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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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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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Studieavstämningsdatum
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Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
1 februari 2028
Avslutad studie (Beräknad)
1 februari 2028
Studieregistreringsdatum
Först inskickad
26 juni 2026
Först inskickad som uppfyllde QC-kriterierna
2 juli 2026
Första postat (Faktisk)
9 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- ST36 Acupoint injection
- 2026ZDSYLL103-P01 (Annan identifierare: Zhongda Hospital Affiliated to Southeast University)
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