Postoperative Pulmonary Complications Clinical Trial
Official title:
The Effect of Continuous Intravenous Infusion of Lidocaine on Postoperative Pulmonary Complications and Prognosis in Emergency Surgical Patients With Intra-abdominal Infection
Verified date | March 2024 |
Source | Shanghai Zhongshan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 428 |
Est. completion date | June 30, 2026 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Hospital,Fudan university | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital | The Affiliated Hospital of Xuzhou Medical University, Tianjin Medical University General Hospital, West China Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To observe the impact of continuous perioperative lidocaine infusion on the levels of neutrophil extracellular traps (NETs) postoperatively | Twenty patients from each group will be selected for blood collection before anesthesia, 24 hours postoperatively, and 7 days postoperatively, to explore the potential mechanisms influencing peripheral blood NETs levels | before anesthesia, 24 hours postoperatively, and 7 days postoperatively | |
Primary | The impact of continuous 24-hour intravenous lidocaine on the incidence of PPCs in patients undergoing emergency laparotomy for IAI. | PPCs are defined as a syndrome encompassing atelectasis, unplanned mechanical ventilation, acute respiratory distress syndrome (ARDS), and postoperative pneumonia occurring within 2 days after surgery. | within 2 days after surgery | |
Secondary | 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 | The protection of important organ function during the perioperative period is defined as the difference in Sequential Organ Failure Assessment (SOFA) scores between the highest preoperative and postoperative 2-day scores (Delta-SOFA), following the "Sepsis 3.0 International Consensus on Sepsis and Septic Shock." | within 30 days postoperatively |
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