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Clinical Trials in China / NCT06304779
Recruiting Not applicable

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

NCT06304779 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Zhongshan Hospital
Phase
Not applicable
Started
2023-10-31
Last updated
2026-04-29

Condition(s) studied

Postoperative Pulmonary ComplicationsIntra-abdominal Infection

Investigational drug(s) / intervention(s)

Lidocaine →Placebo

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.

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital,Fudan university Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06304779 on ClinicalTrials.gov ↗ ← All trials in China