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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06138041
- Acronym / sponsor ID
- scchec-20231113
- Conditions
- Postoperative Pneumonia, Postoperative Pulmonary Atelectasis, Postoperative Pulmonary Edema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine group | Experimental | Drug: intravenous lidocaine infusionAt 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. |
| control group | Placebo comparator | Drug: SalineThe control group will receive the same volume of normal saline in bolus and continuous infusion. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous lidocaine infusionLidocaine 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. | Drug | lidocaine group |
| SalineSame volume of normal saline in bolus and continuous infusion as lidocaine group. | Drug | control group |
Primary outcome
Incidence of PPCs
Time frame: 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
10 secondary outcomes
respiratory infection
Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery
respiratory failure
Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery
pneumothorax;atelectasis
Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery
pleural effusion
Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery
bronchospasm
Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery
aspiration pneumonitis
Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery
anastomotic fistula
Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery
moderate to severe pain within 24 and 48 hours at rest and when coughing
Time frame: 24 and 48 hours after surgery
moderate to severe pain within 24 and 48 hours at coughing
Time frame: 24 and 48 hours after surgery
additional rescue analgesics use
Time frame: 24 and 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Derived from this study: PubMed 41219803Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PPCs (time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06138041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.