RecruitingNot ApplicableNCT06304779

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

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


Sponsor

Shanghai Zhongshan Hospital

Enrollment

428 participants

Start Date

Oct 31, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

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Interventions

DRUGLidocaine

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.

DRUGPlacebo

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


Locations(1)

Zhongshan Hospital,Fudan university

Shanghai, Shanghai Municipality, China

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NCT06304779


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