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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorShanghai Zhongshan Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lidocaine

    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.

  • Placebo

    Drug

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

Treatment groups

428 Participants
are divided into 2 treatment groups
Group A: Control groupPlacebo comparator 1 intervention
Group B: Lidocaine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of PPCs in patients undergoing emergency laparotomy for IAI with or without continuous 24-hour intravenous lidocaine.

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.

Time frame
within 2 days after surgery

Secondary outcomes

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.

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."

Time frame
within 30 days postoperatively

Other outcomes

1

Comparison of postoperative levels of neutrophil extracellular traps (NETs) in patients with or without continuous perioperative lidocaine infusion.

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

Time frame
before anesthesia, 24 hours postoperatively, and 7 days postoperatively

Sponsors and contacts

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Shanghai Zhongshan Hospital

Lead sponsor

The Affiliated Hospital of Xuzhou Medical University

Collaborator

West China Hospital

Collaborator