212 Participants NeededMy employer runs this trial

Lidocaine Ointment for Airway Irritation During Intubation

(ETT LIDOCAINE Trial)

LH
Overseen ByLing-Qun Hu, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether 5% lidocaine ointment (a topical anesthetic) on breathing tubes during surgery can reduce airway irritation, such as coughing and sore throat, compared to the usual water-based lubricant. The researchers aim to determine if the ointment increases patient comfort after surgery and affects the need for pain medication during the operation. Adults scheduled for surgery requiring general anesthesia and a regular breathing tube might be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking medical knowledge.

Is there any evidence suggesting that 5% lidocaine ointment is likely to be safe for humans?

Research has shown that applying lidocaine on the skin can reduce breathing problems in children during airway procedures. Studies have found that placing lidocaine directly on the airway before inserting a breathing tube lowers the chances of these issues. However, using lidocaine as a lubricant on the breathing tube itself did not alleviate problems like sore throat, cough, or hoarseness after the procedure.

Lidocaine is often used to manage reactions during airway procedures, helping to maintain stable heart rate and blood pressure. Possible side effects include numbness or tingling around the mouth, a faster heart rate, and high blood pressure. Research supports its safety, but its effectiveness can depend on the method of application.12345

Why do researchers think this study treatment might be promising?

Unlike the standard water-based lubricants typically used to ease airway irritation during intubation, 5% lidocaine ointment offers a unique advantage by delivering local anesthetic properties directly to the site of irritation. This means it doesn't just lubricate but also numbs the area, potentially reducing discomfort and irritation more effectively. Researchers are excited about this ointment because it could provide quicker, more targeted relief, making the intubation process more comfortable for patients undergoing general anesthesia.

What evidence suggests that 5% lidocaine ointment might be an effective treatment for airway irritation during intubation?

This trial will compare 5% Lidocaine Ointment with a water-based lubricant to reduce airway irritation during intubation. Studies have shown that applying lidocaine to the airway before intubation can reduce irritation. Research indicates that lidocaine lowers the chances of coughing and other breathing problems during the procedure. It also seems to make the airway more comfortable afterward, reducing sore throat and hoarseness. Specifically, one study found that using lidocaine on the airway surface significantly decreased breathing issues in children during similar procedures. Overall, lidocaine is widely used because it helps make intubations smoother and more comfortable, supporting its potential effectiveness in reducing airway irritation during intubation.12467

Are You a Good Fit for This Trial?

This trial is for adults who are having surgery under general anesthesia and need a breathing tube. People with certain medical conditions or allergies may not be able to join.

Inclusion Criteria

American Society of Anesthesiologists (ASA) Physical Status I, II, III, or IV
Patients able to provide informed consent
I am having a major surgery such as abdominal, spinal, brain, bone, or urinary surgery.
See 1 more

Exclusion Criteria

I am allergic to amide local anesthetics.
Current smokers
Prisoners
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Application of 5% lidocaine ointment or standard water-based lubricant to the endotracheal tube before intubation

Intraoperative period
1 visit (in-person)

Emergence and Extubation

Monitoring for incidence of coughing or bucking during emergence from anesthesia

Approximately 5-30 minutes

Follow-up

Assessment of postoperative sore throat and hoarseness at defined postoperative time points

24 hours
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • 5% Lidocaine Ointment

Trial Overview

The study compares two ways of preparing breathing tubes: using 5% lidocaine ointment versus standard water-based lubricant, to see which better reduces coughing and throat discomfort after surgery. Participants are randomly assigned to one group or the other.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: 5% Lidocaine OintmentExperimental Treatment1 Intervention
Group II: Water-Based LubricantActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

Citations

Efficacy of lidocaine via trachospray in postoperative sore ...

The use of 10% lidocaine via Trachospray before endotracheal intubation effectively decreases POST severity and incidence as well as the ...

Lidocaine lubricants for intubation-related complications

8,9,10 Endotracheal lubrication attenuates airway injuries, improves seal, and reduces pulmonary aspiration.11,12 By the combined effect of ...

Site-directed topical lidocaine spray attenuates ...

We found a significantly lower rate of PRAE in children who received topical airway lidocaine before tracheal intubation, when compared with the children who ...

Topical Lidocaine During Airway Manipulation in Pediatric ...

Some studies suggest that it can significantly reduce the incidence of perioperative respiratory adverse events (PRAEs) in children undergoing ...

Intravenous versus topical lidocaine gel administered at ...

Lidocaine is widely used to reduce airway reactivity during extubation; however, evidence comparing intravenous and topical administration routes in adults ...

Topical Lidocaine During Airway Manipulation in Pediatric ...

Some studies suggest that it can significantly reduce the incidence of perioperative respiratory adverse events (PRAEs) in children undergoing elective airway ...

Is lidocaine still recommended for pretreatment during ...

On the other hand, lidocaine effectively prevents MAP and HR fluctuations following endotracheal intubation at these time points. Therefore, lidocaine can ...