Postoperative Pneumonia, Postoperative Pulmonary Atelectasis, Postoperative Pulmonary Edema
Conditions
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.
Interventions
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.
DRUGSaline
Same volume of normal saline in bolus and continuous infusion as lidocaine group.
Sponsors
Sichuan Cancer Hospital and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of PPCs | 1, 2, 3, 4, 5, 6, 7 days after surgery | 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 |
Secondary
| Measure | Time frame |
|---|---|
| respiratory infection | 1, 2, 3, 4, 5, 6, 7 days after surgery |
| respiratory failure | 1, 2, 3, 4, 5, 6, 7 days after surgery |
| pneumothorax;atelectasis | 1, 2, 3, 4, 5, 6, 7 days after surgery |
| pleural effusion | 1, 2, 3, 4, 5, 6, 7 days after surgery |
| additional rescue analgesics use | 24 and 48 hours after surgery |
| aspiration pneumonitis | 1, 2, 3, 4, 5, 6, 7 days after surgery |
| anastomotic fistula | 1, 2, 3, 4, 5, 6, 7 days after surgery |
| moderate to severe pain within 24 and 48 hours at rest and when coughing | 24 and 48 hours after surgery |
| moderate to severe pain within 24 and 48 hours at coughing | 24 and 48 hours after surgery |
| bronchospasm | 1, 2, 3, 4, 5, 6, 7 days after surgery |
Outcome results
None listed