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Study comparing rocuronium dosing based on ideal versus real body weight for airway tube placement in patients with severe obesity

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What is this trial about?

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

This study involves patients with obesity, specifically those with severe obesity where the body mass index is 40 or higher. The study will use rocuronium bromide, which is a medication that temporarily relaxes muscles to help place a breathing tube during surgery. The study will also use propofol, which is a medication used to put patients to sleep during surgery, and sodium chloride, which is a salt solution used to flush the medication through the vein. The purpose of the study is to compare how well the breathing tube can be placed when the dose of rocuronium is calculated based on ideal body weight compared to when it is calculated based on actual body weight in patients with severe obesity.

During the study, patients will be prepared for surgery that requires a breathing tube. They will receive oxygen before the procedure begins. Then they will be given medications to put them to sleep and relax their muscles. The muscle relaxing medication will be given in a dose that is calculated either based on what the patient should ideally weigh or based on what they actually weigh. The doctor will then place the breathing tube and evaluate how easy or difficult it was to do this. The time it takes to place the tube will be measured, and the level of muscle relaxation will be checked. The oxygen levels in the blood will be monitored throughout the procedure.

The study will look at whether excellent conditions for placing the breathing tube are achieved with either dosing method. It will also examine how many patients have acceptable conditions for tube placement, how long it takes to successfully place the tube, and whether any extra techniques are needed to get a better view of the airway. The study will record oxygen levels at different times during the procedure and track any problems that occur, such as drops in oxygen levels or changes in blood pressure. The study is expected to begin enrolling patients in October 2025 and continue until the end of 2028.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Pre-oxygenation
Before the procedure begins, your oxygen levels will be measured using a device placed on your finger called a pulse oximeter, which measures peripheral oxygen saturation (SpO₂).
You will then receive oxygen through a mask to prepare your body for the procedure. This step is called pre-oxygenation.
After pre-oxygenation is complete, your oxygen levels will be measured again.
Step 2
Administration of medications for intubation
You will receive an injection of propofol at a concentration of 10 milligrams per milliliter. This medication will put you to sleep for the surgery.
You will also receive an injection of rocuronium bromide at a concentration of 10 milligrams per milliliter. This medication temporarily relaxes your muscles to allow the breathing tube to be inserted more easily.
The dose of rocuronium bromide you receive will be calculated either based on your ideal body weight (a standard weight for your height) or your real body weight (your actual current weight), depending on which group you are assigned to in the study.
After the rocuronium injection is given, the intravenous line will be flushed with sodium chloride 0.9% solution to ensure all medication enters your bloodstream.
Step 3
Insertion of breathing tube
Approximately 45 seconds after the medication line is flushed, the medical team will assess the level of muscle relaxation using a device that delivers small electrical signals to measure your muscle response. This is called train-of-four (TOF) monitoring.
The breathing tube will then be inserted into your windpipe through your mouth. This procedure is called endotracheal intubation.
The time from when the rocuronium injection line is flushed until the breathing tube is confirmed to be in the correct position will be measured.
The tube placement will be confirmed by a device that detects carbon dioxide in your exhaled breath, called capnography.
If needed, additional techniques may be used to improve the view of your airway, such as gentle pressure on the outside of your throat or use of a special guide wire called a bougie.
Step 4
Monitoring during intubation
Throughout the intubation process, your oxygen levels will be continuously monitored. The lowest oxygen level reached during this time will be recorded.
Your blood pressure and heart rate will also be monitored to detect any changes.
The quality of the intubation conditions will be assessed using a standardized scale called the Fuchs-Borgeat scale, which rates conditions as excellent, good, or poor based on factors such as jaw relaxation, vocal cord position, and your response to tube insertion.
Any complications that occur during the procedure will be documented, including breathing-related events such as low oxygen levels or airway spasm, and blood pressure changes.
Step 5
Continuation of surgery
Once the breathing tube is successfully placed and confirmed to be in the correct position, your scheduled surgery will proceed as planned.
The breathing tube will remain in place throughout your surgery to ensure you receive adequate oxygen and anesthesia.

Who can join the trial?

3 criteria

You must be an adult who is 18 years of age or older
Your BMI (Body Mass Index, which is a measure of body fat based on your height and weight) must be 40 or higher
You must be scheduled for a planned surgery (not an emergency) that requires endotracheal intubation (a procedure where a tube is placed through your mouth into your windpipe to help you breathe during surgery)

Who cannot join the trial?

1 criterion

No specific exclusion criteria have been provided for this clinical trial

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Verified sites

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Az St-Jan Brugge-Oostende A.V.
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Brugge, Belgium
Université Libre de Bruxelles - Hôpital Erasme
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Brussels, Belgium
Vrije Universiteit Brussel
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Jette, Belgium

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Investigated drugs

Rocuronium is a muscle relaxant medication used during anesthesia to temporarily relax your muscles. This helps doctors insert a breathing tube more easily when you need to be put to sleep for surgery. In this study, the medication is being tested at different doses to find the best way to calculate the right amount for patients with obesity.

What is already known about the treatment

Rocuronium – Rocuronium is a muscle relaxant medication that is given through an injection into a vein during surgical procedures to temporarily paralyze muscles, making it easier for doctors to insert a breathing tube into the windpipe. It works by blocking the signals between nerves and muscles at specific connection points called nicotinic receptors, preventing muscles from contracting. This medication belongs to a class of drugs called non-depolarizing neuromuscular blocking agents and is widely used in operating rooms around the world. In this clinical trial, researchers are studying how to best calculate the dose of rocuronium for patients with severe obesity to achieve optimal conditions for placing a breathing tube safely and effectively.

Investigated diseases

Obesity – Obesity is a medical condition characterized by excessive accumulation of body fat in the body. It occurs when a person consumes more calories than they burn over an extended period, leading to weight gain. The condition develops gradually as excess energy is stored as fat tissue throughout the body. Obesity is measured using body mass index, which calculates the relationship between a person's weight and height. The condition can progress from mild to severe forms, with morbid obesity representing the most advanced stage where body mass index reaches 40 or higher. As obesity progresses, it places increasing strain on the body's systems and can affect multiple organs and bodily functions.