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

NCT ID: NCT06304779

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 428 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2026-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Postoperative Pulmonary Complications; Intra-abdominal Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control group

Patients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

atients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively.

Lidocaine group

Patients 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.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

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 strategies. The only difference is the intervention during surgery, with the lidocaine group receiving continuous intravenous lidocaine.

Interventions

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 strategies. The only difference is the intervention during surgery, with the lidocaine group receiving continuous intravenous lidocaine.

Intervention Type: DRUG

Placebo

atients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University General Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital,Fudan university

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

V3.0.2023.11.29

Identifier Type: -

Identifier Source: org_study_id