Comparison of lidocaine spray 10% vs. lidocaine gel 2% for preventing post-intubation and post-extubation complications
| ISRCTN | ISRCTN31659103 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31659103 |
- Submission date
- 04/01/2025
- Registration date
- 01/02/2025
- Last edited
- 16/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
This study focuses on airway management during anesthesia, specifically the process of intubation and extubation. These procedures are essential for keeping the airway open and ensuring proper breathing. However, they come with risks, especially during extubation, such as coughing, airway blockage, and increased heart rate. The study aims to compare the effectiveness of lidocaine spray and gel in reducing these complications, particularly postoperative sore throat (POST) and other issues after surgery.
Who can participate?
Adults aged 18 to 64 years who are undergoing surgery with general anesthesia and endotracheal intubation (GA-ETT), classified as ASA I and II, and whose surgery lasts less than 2 hours can participate.
What does the study involve?
Participants will be divided into three groups:
Group A will receive 10% lidocaine spray at a dose of 1.5 mg/kg body weight.
Group B will receive 2% lidocaine gel at a dose of 1.5 mg/kg body weight.
Group C will receive a saline solution (0.9% NaCl).
All groups will undergo hemodynamic assessments, reflex evaluations, and checks for airway trauma at 2 hours and 24 hours after surgery.
What are the possible benefits and risks of participating?
Possible benefits:
Reduced complications like sore throat, coughing, and airway irritation after intubation and extubation.
Alleviation of discomfort such as sore throat and difficulty swallowing.
More frequent monitoring of vital signs and airway condition, leading to early detection and management of complications.
Contribution to research that could improve anesthesia practices and benefit future patients.
Possible risks:
Local irritation or allergic reactions to lidocaine, such as redness or swelling.
Risk of airway issues like obstruction or laryngospasm if lidocaine is not effective.
Potential systemic side effects from high doses of lidocaine, including dizziness or more severe effects like seizures.
The possibility that lidocaine may not prevent complications for all participants.
Where is the study run from?
The study is being conducted at several hospitals in Medan, Indonesia: Adam Malik Hospital, Putri Hijau Level II Military Hospital, North Sumatra University Hospital, and Dr. Pirngadi General Hospital.
When is the study starting and how long is it expected to run for?
September 2024 to February 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
The main contact for the study is Andriamuri Primaputra Lubis, who can be reached at andriamuri@usu.ac.id.
Contact information
Public, Scientific, Principal Investigator
Tasbih block I NO 66 LK Tanjung sari kecamatan medan selayang
Medan
20131
Indonesia
| Phone | +62 08126078194 |
|---|---|
| andriamuri@usu.ac.id |
Study information
| Study design | Experimental analytical study with a non-randomized design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Comparison of the use of lidocaine spray vs lidocaine gel for post-intubation and post-extubation complications |
| Study acronym | CULSLGFPIPEC |
| Study hypothesis | 2% lidocaine gel is more effective to lower pain assessment 2 hours post-extubation compared to the treatment group using 10% lidocaine spray. |
| Ethics approval(s) |
Approved 02/09/2024, Health Research Ethics Committee of Universitas Sumatera Utara (T. Mansur Street, No. 66, Medan, North Sumatera, Medan, 20155, Indonesia; +62 61 8211045; komiteetik@usu.ac.id), ref: 1108/ KEPK/USU/2024 |
| Condition | Elective surgery patients |
| Intervention | This study is an experimental analytical research with a randomized controlled trial (RCT) design aimed at comparing the effectiveness of 10% Lidocaine Spray and 2% Lidocaine Gel in managing post-intubation and post-extubation complications in patients undergoing elective surgical procedures. The subjects will be randomized using computer-generated randomization through the website randomizer.org. Participants will be divided into three groups: Group A (10% Lidocaine Spray), Group B (2% Lidocaine Gel), and Group C (control group). Group A will receive 10% Lidocaine Spray at a dose of 1.5 mg/kg body weight, Group B will receive 2% Lidocaine Gel at a dose of 1.5 mg/kg body weight, and Group C will receive 0.9% NaCl (saline solution). The subjects will be followed up at several time points (2 hours and 24 hours post-surgery) to assess post-extubation complications and the need for rescue analgesics, with a total follow-up duration of 24 hours. In the case of post-extubation complications, patients will receive rescue medication in the form of dexamethasone 0.2 mg/kg, after obtaining approval from the attending physician |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacodynamic |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 2% lidocaine gel and 10% lidocaine |
| Primary outcome measure | 1. Diastolic Blood Pressure is measured using Non-invasive Blood Pressure at baseline, 2 hours, and 24 hours post-surgery 2. Systolic Blood Pressure is measured using Non-invasive Blood Pressure at baseline, 2 hours, and 24 hours post-surgery 3. Heart rate (Pulse) is measured using monitor at baseline, 2 hours, and 24 hours post-surgery 4. Postoperative Sore Throat (POST) is measured using Post Scoring at baseline, 2 hours, and 24 hours post-surgery 5. Post-extubation complication are assessed using vital signs assessment by monitor (Systolic and diastolic blood pressure, patient’s heart rate) at baseline, 2 hours, and 24 hours post-surgery |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 02/09/2024 |
| Overall study end date | 02/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 64 Years |
| Sex | Both |
| Target number of participants | 90 |
| Total final enrolment | 95 |
| Participant inclusion criteria | 1. Patients undergoing surgery 2. General Anesthesia and Endotracheal Tube (GA-ETT) 3. Aged between 18 and 64 years 4. Classified as ASA (American Society of Anesthesiologists) I or II 5. Surgeries lasting less than 2 hours |
| Participant exclusion criteria | Patients predicted to encounter intubation difficulties |
| Recruitment start date | 15/12/2024 |
| Recruitment end date | 31/01/2025 |
Locations
Countries of recruitment
- Indonesia
Study participating centres
Medan
20136
Indonesia
Medan
20111
Indonesia
Medan
20154
Indonesia
Sponsor information
University/education
Dr. T. Mansur No.9, Padang Bulan, Kec. Medan Baru, Kota Medan, Sumatera Utara
Medan
20222
Indonesia
| Phone | +62 (061) 8211045 |
|---|---|
| dean.med@usu.ac.id | |
| Website | https://usu.ac.id |
"ROR" |
https://ror.org/01kknrc90 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Andriamuri P Lubis (andriamuri@usu.ac.id) |
Editorial Notes
16/01/2025: Trial's existence confirmed by Health Research Ethics Committee of Universitas Sumatera Utara
