Clinical trial NCT06138041: Intravenous Lidocaine Infusion Reduce Postoperative Pulmonary Complications in Patients Undergoing Minimally Invasive Esophagectomy
Official title: Effect of Intravenous Lidocaine Infusion on Postoperative Pulmonary Complications in Patients Undergoing Minimally Invasive Esophagectomy: a Double-center, Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pneumonia
Postoperative Pulmonary Atelectasis
Postoperative Pulmonary Edema
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 770
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this double-center, double-blind, randomized controlled clinical trial is to compare the effect of intravenous lidocaine infusion on postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy. The main question it aims to answer are whether intravenous lidocaine reduce postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy. Participants will be given intravenous lidocaine infusion in lidocaine group or placebo in control group.


Eligibility criteria: Inclusion Criteria:

Patients between 18 and 85 years of age with a recent schedule for MIE are screened for this study. Patients who show clear consciousness and ASA status I - III will be included as eligible participants.

Exclusion Criteria:

The exclusion criteria are as follows: patients with severe psychiatric disorders, such as schizophrenia, depression, dementia, etc.; severe hepatic insufficiency (concentration of glutamic oxaloacetic transaminase, glutamic pyruvic transaminase or bilirubin ≥2.5 times the upper limit of normal); renal impairment (creatinine clearance \<60 mL/min); allergy to amide local anesthetics; history of seizures; presence of II/III atrioventricular block; patients with severe sinus bradycardia or sick sinus syndrome; patients with Adams-Stokes syndrome or pre-excitation syndrome; intracardiac block (e.g. complete bundle branch block, atrioventricular block); serum potassium ion concentration below 2.5 or above 5.0 mmol/L; PH\>7.55 or PH\<7.2. Patients will be discontinued if any of the following situations occur: the patient has an allergic reaction, severe cardiovascular events that cannot be managed with symptomatic treatment, and the patient is unwilling to continue the study.

Primary outcomes:
measure: Incidence of PPCs
timeFrame: 1, 2, 3, 4, 5, 6, 7 days after surgery
Secondary outcomes:
measure: respiratory infection
timeFrame: 1, 2, 3, 4, 5, 6, 7 days after surgery
measure: respiratory failure
timeFrame: 1, 2, 3, 4, 5, 6, 7 days after surgery
measure: pneumothorax;atelectasis
timeFrame: 1, 2, 3, 4, 5, 6, 7 days after surgery
measure: pleural effusion
timeFrame: 1, 2, 3, 4, 5, 6, 7 days after surgery
measure: bronchospasm
timeFrame: 1, 2, 3, 4, 5, 6, 7 days after surgery
measure: aspiration pneumonitis
timeFrame: 1, 2, 3, 4, 5, 6, 7 days after surgery
measure: anastomotic fistula
timeFrame: 1, 2, 3, 4, 5, 6, 7 days after surgery
measure: moderate to severe pain within 24 and 48 hours at rest and when coughing
timeFrame: 24 and 48 hours after surgery
measure: moderate to severe pain within 24 and 48 hours at coughing
timeFrame: 24 and 48 hours after surgery
measure: additional rescue analgesics use
timeFrame: 24 and 48 hours after surgery
Other outcomes:
Locations:
Study officials:
References: