Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

2 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

90

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Airan Liu professor
  • Numero di telefono: 8615295557466
  • Email: airanliu@126.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: neostigmine injection at the acupoints
Droga: 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.
Comparatore attivo: intramuscular injection of normal saline
Droga: 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.
Comparatore attivo: subcutaneous injection of neostigmine
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Remission rate of gastrointestinal symptoms within 24 hours
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mortalità in terapia intensiva
Lasso di tempo: fino a 24 mesi
il tasso di sopravvivenza(sopravvivenza/totale) durante il soggiorno in terapia intensiva
fino a 24 mesi
28-day mortality
Lasso di tempo: From randomization to Day 28
Mortality was calculated on day 28 of treatment
From randomization to Day 28
Length of ICU stay
Lasso di tempo: up to 28 days
Time of staying in ICU within 28 days
up to 28 days
Infection condition
Lasso di tempo: From randomization to Day 28
Infection condition within 28 days
From randomization to Day 28
28-day vasopressor-free days
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: prior to hospital discharge
Length of hospital stay
prior to hospital discharge
Enteral Nutrition Prescription
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Southeast University, China

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 febbraio 2028

Completamento dello studio (Stimato)

1 febbraio 2028

Date di iscrizione allo studio

Primo inviato

26 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Neostigmine Acupoint Injection

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Vietnam

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi