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Acupoint injection may ease gut troubles in ventilated patients

NCT ID NCT07692282

Symptom relief Sponsor: Southeast University, China Source: ClinicalTrials.gov ↗

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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

Expanded access (not trials)

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First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial investigates whether injecting neostigmine into the Zusanli acupoint (ST36) can improve gastrointestinal function in patients on mechanical ventilation. The study compares this approach to acupoint stimulation alone or subcutaneous neostigmine injection. Participants are critically ill adults expected to need a breathing machine for at least 48 hours and who have not had a bowel movement for 48 hours or have high gastric residual volume. The main goal is to see if the treatment increases the rate of bowel movements and reduces stomach retention within 24 hours.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
neostigmine
What this could lead to
If effective, this approach could offer a simple, low-cost way to relieve gut problems in critically ill patients on breathing machines.
What could go wrong
This is a small, early-stage trial (90 participants) at a single center. The results may not apply broadly, and neostigmine can cause side effects like bradycardia or excessive salivation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Gastrointestinal dysfunction

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