Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Effect of intravenous Lidocaine bolus on the median effective concentration (EC50) of Propofol during target controlled infusion (TCI : Schnider model) for gastroscopy in adult patients : a prospective, randomized, double-blinded study

This research is investigating whether giving a small amount of lidocaine, a medicine often used to numb areas or treat certain pains, through a drip can reduce how much propofol is needed during a gastroscopy. A gastroscopy is a procedure where a doctor looks inside your stomach using a thin, flexible tube. Propofol is a medicine that helps you relax or fall asleep during the procedure. The study aims to make the gastroscopy experience better by potentially decreasing the amount of propofol required, which could lead to fewer side effects and a quicker recovery. It's a randomised study, meaning participants are put into groups by chance, and adult patients are involved.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Hopital Erasme

Enrolment target

Start

25 Mar 2024

Gastroscopy

What is this study about?

This study is designed to see if giving a small dose of lidocaine, which is a medicine sometimes used as a local anaesthetic or to help with certain types of pain, can reduce the amount of another medicine called propofol needed for a gastroscopy. A gastroscopy is a common procedure where a doctor uses a thin, flexible tube with a camera to look inside your oesophagus (food pipe), stomach, and the first part of your small intestine. During this procedure, you are usually given propofol to help you relax or go to sleep so you don't feel uncomfortable.

The main goal of this study is to find out the 'sweet spot' for propofol – the lowest dose that still allows the doctor to comfortably insert the scope without you moving. By adding lidocaine, the researchers hope to lower this amount. This could mean you wake up more quickly, feel less sleepy afterwards, and potentially experience fewer side effects that can sometimes happen with propofol, such as low blood pressure or breathing issues. They will also look at how satisfied patients and doctors are with the procedure and check for any common side effects like a sore throat or low oxygen levels.

This is a 'Phase IV' study, which means the medicines involved are already approved and widely used. The study is simply looking for better ways to use them together for a specific procedure. It's a 'double-blinded' study, which means neither you nor your doctor will know if you're receiving lidocaine or an inactive salty water solution (placebo) – this helps make the results as fair and unbiased as possible.

Key takeaways

Tests if lidocaine can reduce the amount of sleep medicine (propofol) needed for gastroscopy.
Aims to make gastroscopy more comfortable and safer.
Compares lidocaine to a simple salty water solution (placebo).
Looks at patient and doctor satisfaction, recovery time, and common side effects.
Open to adults aged 18 and over.

Who may be eligible?

To take part in this study, you would need to be 18 years old or older. There is no upper age limit, and both men and women can participate. This ensures the study includes a broad range of adults undergoing a gastroscopy.

More detailed specific health requirements would be discussed with you by the research team. This is to make sure the study is safe for you and that the results can be properly understood. For example, some existing health conditions or medicines you are taking might mean you can't join the study, but the team will guide you through this.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled for a gastroscopy procedure?
Are you generally healthy enough to undergo a gastroscopy?
Are you willing to potentially receive either lidocaine or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups: one group would receive a small dose of lidocaine through a drip before your gastroscopy, and the other group would receive a simple salty water solution (placebo) through a drip. You wouldn't know which one you received.

During your gastroscopy, the research team would carefully adjust the amount of propofol you receive to ensure you are comfortable. They would monitor your vital signs, such as your blood pressure and oxygen levels, very closely. After your procedure, they would check for things like throat pain and how quickly you recover your awareness. You would also be asked about your comfort and satisfaction with the experience. The entire process would involve your standard gastroscopy appointment, with a few extra observations and questions during and shortly after the procedure, typically until you are ready to be discharged from the recovery room, usually about an hour after the procedure finishes.

Potential risks and benefits

Participating in this study might offer a potential benefit if lidocaine helps reduce the amount of propofol needed, possibly leading to a quicker recovery and fewer side effects compared to the standard approach. However, there's always a chance of side effects with any medication, including lidocaine (like a metallic taste or ringing in the ears, though serious reactions are very rare) or propofol. All medical procedures carry some risks, and the study team will monitor you closely to minimise these. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is a gastroscopy?

A gastroscopy is a procedure where a doctor looks inside your food pipe, stomach, and the first part of your small bowel using a thin, flexible tube with a camera.

What is propofol?

Propofol is a medicine that helps you relax or go to sleep during procedures like a gastroscopy, making it more comfortable for you.

What is lidocaine?

Lidocaine is a medicine often used to numb parts of the body or treat certain kinds of pain. In this study, it's given through a drip.

Will I know if I'm getting lidocaine or not?

No, this is a 'double-blinded' study, meaning neither you nor the doctors will know if you're receiving lidocaine or a salty water solution until after the study is over.

What happens after the procedure?

After your gastroscopy, the team will monitor your recovery, ask you some questions about your comfort, and check for any discomfort like a sore throat.