Study on Neostigmine Acupoint Injection at Zusanli(ST36) for Treating Mechanical Ventilation-Associated Gastrointestinal Dysfunction
2026年7月2日 更新者：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.
調査の概要
状態
状態
まだ募集していません
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
介入
入学 (推定)
入学
90
段階
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
研究連絡先
- 名前：Airan Liu professor
- 電話番号：8615295557466
- メール：airanliu@126.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
3
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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アクティブコンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Remission rate of gastrointestinal symptoms within 24 hours
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ICU死亡率
時間枠：最長24か月
|
ICU滞在中の生存率（生存数／総数）
|
最長24か月
|
|
28-day mortality
時間枠：From randomization to Day 28
|
Mortality was calculated on day 28 of treatment
|
From randomization to Day 28
|
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Length of ICU stay
時間枠：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
時間枠：From randomization to Day 28
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Infection condition within 28 days
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From randomization to Day 28
|
|
28-day vasopressor-free days
時間枠：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
時間枠：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
時間枠：prior to hospital discharge
|
Length of hospital stay
|
prior to hospital discharge
|
|
Enteral Nutrition Prescription
時間枠：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
|
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Intra-abdominal pressure(mmHg)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
研究開始
2026年7月1日
一次修了 (推定)
一次修了
2028年2月1日
研究の完了 (推定)
研究の完了
2028年2月1日
試験登録日
最初に提出
最初に提出
2026年6月26日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年7月2日
最初の投稿 (実際)
最初の投稿
2026年7月9日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年7月9日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年7月2日
最終確認日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- ST36 Acupoint injection
- 2026ZDSYLL103-P01 (その他の識別子：Zhongda Hospital Affiliated to Southeast University)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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