The Effect of Continuous Intravenous Infusion of Lidocaine on PPCs and Prognosis in Emergency Surgical Patients With IAI

Официальное название

The Effect of Continuous Intravenous Infusion of Lidocaine on Postoperative Pulmonary Complications and Prognosis in Emergency Surgical Patients With Intra-abdominal Infection

Обзор

The main purpose of this study is to evaluate the impact of continuous 24-hour intravenous infusion of lidocaine on the incidence of PPCs in patients undergoing emergency laparotomy for intra-abdominal infection (IAI).The secondary objectives of this study are to assess the impact of continuous 24-hour intravenous lidocaine infusion on the proportion of patients requiring mechanical ventilation, protection of important organ function during the perioperative period, length of hospital stay, and outcomes within 30 days postoperatively.

Подробное описание

PPCs are defined as the occurrence within 2 days postoperatively of atelectasis unplanned ventilation, acute respiratory distress syndrome (ARDS), and postoperative pneumonia syndrome Unplanned ventilation postoperatively: Defined as the use of non-invasive mechanical ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) after the first extubation postoperatively or if extubation cannot be performed as planned.

Acute Respiratory Distress Syndrome (ARDS): Defined as acute diffuse inflammatory lung injury leading to increased pulmonary vascular permeability, increased lung weight, loss of aerated lung tissue, hypoxemia, and bilateral opacities on imaging (using the Berlin Consensus definition).

Postoperative pneumonia: Defined according to the diagnostic criteria in the "Chinese Adult Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia Diagnosis and Treatment Guidelines" (2018 version): new or progressive infiltrates, consolidation, or ground-glass opacities on chest X-ray or CT, along with two or more of the following clinical symptoms: ① fever (\> 38.0°C), ② purulent respiratory secretions, ③ peripheral blood leukocyte count \> 10×10\^9/L or \< 4×10\^9/L.

Вмешательства

• Препарат Lidocaine
  Lidocaine group receive a loading dose of 1.5 mg/kg 2% lidocaine at anesthesia induction, followed by continuous intravenous infusion at 1.5 mg/kg/h until 24 hours postoperatively and Control group receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively. Both groups will receive the same anesthesia and postoperative analgesia protocols, lung-protective ventilation strategy, and fluid, transfusion, and warming s
• Препарат Placebo
  Patients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively.

Первичные конечные точки

• The incidence of PPCs in patients undergoing emergency laparotomy for IAI with or without continuous 24-hour intravenous lidocaine. [Срок оценки: within 2 days after surgery]

Вторичные конечные точки (1)

• Proportion of patients requiring mechanical ventilation and protection of important organ function during the perioperative period: with versus without continuous 24-hour intravenous lidocaine infusion. [Срок оценки: within 30 days postoperatively]

Критерии участия

Критерии включения

• Age >18 years, any gender.
• Patients suspected of digestive tract perforation or obstruction based on physical examination, confirmed by imaging, requiring emergency surgical treatment.
• The anesthesia method is general anesthesia
• I or the patient's family have carefully read and signed the informed consent form
• Serum procalcitonin (PCT) at inflammatory levels or leukocytosis (>12×109/L) or leukopenia (<4×109/L) or >10% naive leukocytes

Критерии исключения

• Have a history of local anesthesia drug allergy
• Pregnant patients
• Patients receiving renal replacement therapy
• Patients with arrhythmias or heart failure (second or third-degree atrioventricular block or left ventricular ejection fraction（LVEF）
• Preoperative platelet count<80 × 109/L
• Patients who require secondary surgery for postoperative anastomotic fistula
• Patients who have participated in other clinical studies

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Zhongshan Hospital,Fudan university — Шанхай

Идентификаторы

NCT: NCT06304779 · V3.0.2023.11.29

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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