Intravenous Lidocaine Infusion Reduce Postoperative Pulmonary Complications in Patients Undergoing Minimally Invasive Esophagectomy

Postoperative Pulmonary Atelectasis Clinical Trial

Official title:

Effect of Intravenous Lidocaine Infusion on Postoperative Pulmonary Complications in Patients Undergoing Minimally Invasive Esophagectomy: a Multicenter, Double-blind, Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06138041
• Other study ID #: scchec-20231113
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this multicenter, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 770
• Est. completion date: September 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Pneumonia
• Postoperative Pulmonary Atelectasis
• Pulmonary Atelectasis
• Pulmonary Edema

Intervention

Drug:
• intravenous lidocaine infusion
Lidocaine bolus of 2mg/kg after induction , and then continuous infusion with 2 mg/kg/h until the participate transfer out of postoperative anesthesia care unit.
• Saline
Same volume of normal saline in bolus and continuous infusion as lidocaine group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Cancer Hospital and Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of PPCs	Pulmonary complications is defined as one or more of the following complications: respiratory infection; respiratory failure; pneumothorax;atelectasis; pleural effusion; bronchospasm; aspiration pneumonitis; anastomotic fistula	1, 2, 3, 4, 5, 6, 7 days after surgery
Secondary	respiratory infection		1, 2, 3, 4, 5, 6, 7 days after surgery
Secondary	respiratory failure		1, 2, 3, 4, 5, 6, 7 days after surgery
Secondary	pneumothorax;atelectasis		1, 2, 3, 4, 5, 6, 7 days after surgery
Secondary	pleural effusion		1, 2, 3, 4, 5, 6, 7 days after surgery
Secondary	bronchospasm		1, 2, 3, 4, 5, 6, 7 days after surgery
Secondary	aspiration pneumonitis		1, 2, 3, 4, 5, 6, 7 days after surgery
Secondary	anastomotic fistula		1, 2, 3, 4, 5, 6, 7 days after surgery
Secondary	moderate to severe pain within 24 and 48 hours at rest and when coughing		24 and 48 hours after surgery
Secondary	moderate to severe pain within 24 and 48 hours at coughing		24 and 48 hours after surgery
Secondary	additional rescue analgesics use		24 and 48 hours after surgery