Not recruiting

Study on the Effect of Lidocaine and Propofol on Sedation Levels During Gastroscopy in Adults

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding the effects of certain medications during a medical procedure called a gastroscopy, which is a test to look inside the stomach using a small camera. The study involves the use of three medications: Propofol, Lidocaine, and Sodium Chloride. Propofol is a medication that helps patients relax and fall asleep during medical procedures. Lidocaine is used to numb areas of the body and reduce pain. Sodium Chloride, also known as salt water, is often used in medical settings to help deliver medications through the veins.

The purpose of this study is to see how an injection of Lidocaine affects the amount of Propofol needed to keep patients comfortable during a gastroscopy. The study is designed to be double-blinded, meaning neither the patients nor the researchers know who is receiving which treatment, to ensure unbiased results. Participants will receive either the medications or a placebo, and the effects will be carefully monitored. The study will also look at how these medications affect things like breathing, blood pressure, and any side effects that might occur.

Throughout the study, participants will be closely observed to ensure their safety and comfort. The researchers will measure how well the medications work by looking at how much Propofol is needed to keep patients still during the procedure and by checking for any side effects. The study will also gather feedback from both the doctors performing the procedure and the patients themselves to understand their satisfaction with the process. This research aims to improve the experience and safety of patients undergoing gastroscopy by finding the best way to use these medications together.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age, health status, and language proficiency.
Informed consent is required, ensuring understanding of the study's purpose and procedures.
Step 2
Preparation for procedure
Before the procedure, a medical assessment is conducted to ensure readiness for the gastroscopy.
An intravenous line is established for medication administration.
Step 3
Medication administration
A lidocaine bolus is administered intravenously at a dose of 1.5 mg per kg of ideal body weight.
Following the lidocaine, propofol is given through a target-controlled infusion to maintain sedation during the procedure.
Step 4
Gastroscopy procedure
The gastroscopy is performed while monitoring the effectiveness of the sedation.
The primary goal is to determine the median effective concentration of propofol required for the procedure.
Step 5
Monitoring and recovery
During and after the procedure, vital signs are closely monitored to detect any side effects such as hypoxemia or hypotension.
Recovery from anesthesia is assessed, and the time taken to reach a specific recovery score is recorded.
Step 6
Post-procedure evaluation
Patient satisfaction and any side effects experienced are evaluated approximately one hour after the procedure.
The endoscopist's satisfaction with the procedure is also recorded.
Step 7
Discharge
Once recovery criteria are met, discharge from the post-anesthetic care unit is completed.
Instructions for post-procedure care and follow-up are provided.

Who can join the trial?

6 criteria

All patients who need to have a **gastroscopy** (a procedure to look inside the stomach) under anesthesia at the ERASME hospital.
Age between 18 and 65 years.
**ASA score I or II**: This is a way to classify how healthy a person is before surgery. Score I means a healthy person, and score II means a person with mild health issues.
**Body mass index (BMI)** between 18 and 30 kg/m²: BMI is a number calculated from a person's weight and height to see if they have a healthy weight.
Must be able to speak and understand French.
Must have signed a written informed consent, which means agreeing to participate after understanding the study details.

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Verified sites

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Verified
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Belgium

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Investigated drugs

Lidocaine
is a medication used in this trial to see how it affects the amount of another drug, Propofol, needed during a medical procedure called gastroscopy. Lidocaine is given through an injection into a vein. It is commonly used to numb areas of the body or to treat certain types of pain. In this study, researchers are looking at how Lidocaine might change the effectiveness of Propofol, which is used to help patients relax or sleep during the procedure.
Propofol
is a medication used to help patients relax or sleep during medical procedures. In this trial, Propofol is given through a method called target controlled infusion, which helps control the amount of the drug in the body. The study aims to find out how much Propofol is needed when Lidocaine is also used. Propofol is commonly used for its quick action and ability to help patients recover quickly after the procedure.

What is already known about the treatment

Lidocaine
Lidocaine is administered intravenously in this clinical trial, specifically as a bolus injection. It is currently being studied for its potential to reduce the required concentration of Propofol during anesthesia for gastroscopy. Lidocaine is primarily used as a local anesthetic and antiarrhythmic agent. It works by blocking sodium channels in nerve cells, which prevents the initiation and transmission of nerve impulses, leading to a numbing effect. It is classified as a local anesthetic and antiarrhythmic medication.
Propofol
Propofol is administered intravenously and is used in this study as part of a target-controlled infusion for anesthesia during gastroscopy. It is a well-established anesthetic agent used for the induction and maintenance of general anesthesia. Propofol works by enhancing the activity of the neurotransmitter GABA at its receptor, leading to sedative and hypnotic effects. It is classified as a general anesthetic.

Investigated diseases

Gastroscopy – Gastroscopy is a medical procedure used to examine the inside of the esophagus, stomach, and the first part of the small intestine. It involves the use of a thin, flexible tube called an endoscope, which is equipped with a light and camera. The procedure is typically performed to investigate symptoms such as persistent stomach pain, difficulty swallowing, or unexplained weight loss. During the procedure, the endoscope is gently inserted through the mouth and down the throat. It allows doctors to view the lining of the upper digestive tract and take tissue samples if necessary. Gastroscopy is generally safe and provides valuable information for diagnosing various gastrointestinal conditions.