Intraoperative Nebulization of Lidocaine and Postoperative Pulmonary Complications

NCT07000760 | Completed Phase 3 DMC

• 1 other identifier: 2504-Exp179
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 2

Brief Summary

There is high incidence of postoperative pulmonary complications (PPCs) in patients undergoing major abdominal surgeries.PPCs significantly prolongs the hospital stay of patients, increases their economic burden, and raises the mortality rates within 30 days and 1 year after surgery. The inflammatory response during the perioperative period plays an important role in the occurrence and development of PPCs. The anti-inflammatory effect of lidocaine has a potential lung protection mechanism. The purpose of this study is to explore the effect of nebulization of lidocaine on the incidence of PPCs. The investigators hypothesized that intraoperative nebulization of lidocaine could reduce the incidence of PPCs.

Conditions

Postoperative Pulmonary Complications (PPCs)

Keywords

Postoperative pulmonary complications; Lidocaine

Outcome Measures

Primary Outcomes (1)

• The incidence of PPCs within seven days after surgery

  Up to one week

Secondary Outcomes (3)

• ICU admission rate

  Up to one week

• Hospital stay

  Perioperative

• Postoperative pain score

  Up to one week

Study Arms (2)

lidocaine

EXPERIMENTAL

After anesthetic induction and before the end of the surgery, 100mg of 2% lidocaine was nebulized and inhaled respectively.

Drug: Nebulization of lidocaine

saline

PLACEBO COMPARATOR

After anesthetic induction and before the end of the surgery, the same volume of normal saline (5ml of 0.9% NaCl) was nebulized.

Drug: Nebulization of normal saline

Interventions

Nebulization of lidocaine DRUG

After induction of general anesthesia and before the end of the surgery, 100mg of 2% lidocaine was nebulized and inhaled respectively, and the nebulization time was 15-20 minutes each time.

Also known as: 1

lidocaine

Nebulization of normal saline DRUG

After anesthesia induction and before the end of the surgery, the same volume of normal saline (5ml of 0.9% NaCl) was nebulized, and the nebulization time was 15-20 minutes each time.

Also known as: 2

saline

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have signed the informed consent form and are willing to complete the study according to the protocol
• Age ≥18 years old and ≤90 years old
• ASA classification grades I-III
• Elective major non-cardiac surgery
• General anesthesia under tracheal intubation
• Monitor invasive arterial blood pressure
• The expected operation time ≥2 hours

You may not qualify if:

• Untreated ischemic heart disease Severe cardiovascular and cerebrovascular diseases
• Severe asthma, pulmonary bullae, pneumothorax, bronchopleural fistula, etc
• Severe underlying liver and kidney diseases
• Age under 18 years old or over 90 years old
• The expected operation time is ≥2 hours

Sponsors & Collaborators

• Jun Zhang: lead

Study Sites (2)

Fudan University Shanghai Cancer Centre

Shanghai, Shanghai Municipality, 200032, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Study Officials

• Jun Zhang Fudan University Shanghai Cancer Centre, Professor

  Fudan University Shanghai Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 3, 2025
• Study Start: June 6, 2025
• Primary Completion: January 23, 2026
• Study Completion: January 30, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)