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

2. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Airan Liu professor
  • Telefonnummer: 8615295557466
  • E-mail: airanliu@126.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: neostigmine injection at the acupoints
Medicin: 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.
Aktiv komparator: intramuscular injection of normal saline
Medicin: 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.
Aktiv komparator: subcutaneous injection of neostigmine
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Remission rate of gastrointestinal symptoms within 24 hours
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ICU-dødelighed
Tidsramme: op til 24 måneder
overlevelsesprocenten (overlevelse/total) under intensiv behandling
op til 24 måneder
28-day mortality
Tidsramme: From randomization to Day 28
Mortality was calculated on day 28 of treatment
From randomization to Day 28
Length of ICU stay
Tidsramme: up to 28 days
Time of staying in ICU within 28 days
up to 28 days
Infection condition
Tidsramme: From randomization to Day 28
Infection condition within 28 days
From randomization to Day 28
28-day vasopressor-free days
Tidsramme: 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
Tidsramme: 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
Tidsramme: prior to hospital discharge
Length of hospital stay
prior to hospital discharge
Enteral Nutrition Prescription
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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Sponsor

Southeast University, China

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. februar 2028

Studieafslutning (Anslået)

1. februar 2028

Datoer for studieregistrering

Først indsendt

26. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

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

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