Postoperative PneumoniaNCT06138041
Intravenous Lidocaine Infusion Reduce Postoperative Pulmonary Complications in Patients Undergoing Minimally Invasive Esophagectomy
A study testing intravenous lidocaine infusion and Saline in people with Postoperative Pneumonia and Postoperative Pulmonary Atelectasis, run by Sichuan Cancer Hospital and Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pneumonia, Postoperative Pulmonary Atelectasis, Postoperative Pulmonary Edema
- What is being tested?
- intravenous lidocaine infusion and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 770 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 30 Aug 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
- Conditions
- Postoperative Pneumonia, Postoperative Pulmonary Atelectasis, Postoperative Pulmonary Edema
- Being tested
- intravenous lidocaine infusion, Saline
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous lidocaine infusionDrug
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.
SalineDrug
Same volume of normal saline in bolus and continuous infusion as lidocaine group.
| Study group | Role | What they receive |
|---|---|---|
| lidocaine group | Experimental | At the same time of induction of general anesthesia, an intravenous lidocaine bolus of 2mg/kg will be administered, followed by a continuous infusion of intravenous lidocaine at 2 mg/kg/h until the participate transfer out of postoperative anesthesia care unit. Receives: Drug: intravenous lidocaine infusion |
| control group | Placebo comparator | The control group will receive the same volume of normal saline in bolus and continuous infusion. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1, 2, 3, 4, 5, 6, 7 days after surgery
Secondary outcomes (10)
respiratory infection
Measured: 1, 2, 3, 4, 5, 6, 7 days after surgery
respiratory failure
Measured: 1, 2, 3, 4, 5, 6, 7 days after surgery
pneumothorax;atelectasis
Measured: 1, 2, 3, 4, 5, 6, 7 days after surgery
pleural effusion
Measured: 1, 2, 3, 4, 5, 6, 7 days after surgery
bronchospasm
Measured: 1, 2, 3, 4, 5, 6, 7 days after surgery
aspiration pneumonitis
Measured: 1, 2, 3, 4, 5, 6, 7 days after surgery
anastomotic fistula
Measured: 1, 2, 3, 4, 5, 6, 7 days after surgery
moderate to severe pain within 24 and 48 hours at rest and when coughing
Measured: 24 and 48 hours after surgery
moderate to severe pain within 24 and 48 hours at coughing
Measured: 24 and 48 hours after surgery
additional rescue analgesics use
Measured: 24 and 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Feb 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yihao Zhu, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138041
- Sponsor's protocol ID
- scchec-20231113
- Status last verified
- Oct 2024
- First submitted
- 13 Nov 2023
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang F, Zhang H, Peng X, Liu M, Wang H, Song Y, Jia X, Zhu T, Zhu Y. Effect of intravenous lidocaine infusion on postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy: a study protocol of double-center, double-blind, randomized controlled trial. Trials. 2025 Nov 11;26(1):490. doi: 10.1186/s13063-025-09213-x.
PubMed 41219803