Study on the Impact of Sufentanil Citrate and Remifentanil on Heart Rate During Rapid Sequence Intubation in Patients Over 55 with High Anesthesia Risk

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What is this study about?

This clinical trial is focused on understanding how certain medications affect heart rate during a medical procedure called rapid sequence intubation. This procedure is often used in patients who need to be put under general anesthesia quickly, especially if they have a full stomach, which can increase the risk of complications. The study involves patients who are either over 65 years old or between 55 and 65 years old with certain health conditions. The main goal is to see how different medications, specifically opioids, impact the heart rate during this procedure.

The medications being studied include sufentanil citrate, remifentanil, and sodium chloride. Sufentanil citrate and remifentanil are types of opioids, which are strong pain-relieving drugs often used during surgeries. Sodium chloride is a simple salt solution that is commonly used in medical settings. These medications will be given through an intravenous injection, which means they are delivered directly into the bloodstream through a vein.

During the study, participants will receive one of these medications, and their heart rate will be monitored to see how it changes from the time they enter the operating room until the end of the intubation process. The study is designed to be double-blind, meaning neither the participants nor the researchers know which medication is being given to each participant, to ensure unbiased results. The findings from this study could help improve the safety and effectiveness of rapid sequence intubation in patients who require it.

1 joining the study

Upon joining the study, you will be informed about the procedures and asked to provide written consent. This is to ensure you understand the study and agree to participate.

2 preparation for surgery

Before the surgery, you will be assessed to confirm your eligibility. This includes checking your age and health status, particularly if you are over 65 years old or between 55 and 65 with certain health conditions.

You will be considered for rapid sequence induction if you have a ‘full stomach,’ which means you may have certain digestive conditions or have not fasted as required.

3 administration of medications

During the procedure, you will receive medications through an intravenous injection. These medications include sodium chloride, sufentanil citrate, and remifentanil.

Sodium chloride is a solution used to maintain fluid balance. Sufentanil citrate and remifentanil are opioids used to manage pain and sedation during the procedure.

4 monitoring heart rate

Your heart rate will be closely monitored during the procedure. The main objective is to assess how the opioids affect your heart rate during the intubation process.

The primary measurement will be the change in heart rate from the time you enter the operating room to the end of the intubation.

5 post-procedure observation

After the procedure, you will be observed for any immediate effects, such as changes in heart rate or blood pressure.

Additional observations may include any signs of vomiting, the need for additional medications, or any other reactions.

Who Can Join the Study?

Patient over 65 years old with any possible ASA (American Society of Anesthesiologists physical status classification) OR Patient aged 55 to 65 years old with an ASA of 3 or higher.
Patient undergoing surgery (urgent or scheduled) that requires general anesthesia in rapid sequence because they are considered to have a “full stomach.” This means they have one of the following conditions: gastro-oesophageal pathology (problems with the stomach and esophagus), gastroparesis (slow stomach emptying), a history of bariatric surgery (weight loss surgery), occlusive syndrome (blockage in the digestive system, with or without a naso-gastric tube), or have not followed the rule of no food for less than 6 hours and/or no water for less than 2 hours before surgery.
Patient can participate regardless of their Body Mass Index (BMI), which is a measure of body fat based on height and weight.
Patient can participate regardless of their orotracheal intubation criteria present during the anesthesia consultation. Orotracheal intubation is a procedure where a tube is placed into the windpipe through the mouth to help with breathing during surgery.
Patient must be informed about the study and must give their written consent before starting the study procedures.
Patient must be affiliated with a French social security system.

Who Cannot Join the Study?

Patients who are not between the ages of 55 and 65 years old.
Patients who are 55-65 years old with an ASA score greater than 3. ASA score is a system used to assess the physical health of patients before surgery.
Patients over 65 years old with any ASA score.
Patients who do not require rapid sequence induction. This is a quick method used to put someone to sleep for surgery when they have a full stomach.
Patients who are not considered to have a full stomach during the anesthesia consultation.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Sud Francilien	Corbeil Essonnes	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	02.01.2023

Trial locations

Investigated drugs:

Opioids are a group of medications often used to relieve pain. In this clinical trial, they are being studied to see how they affect heart rate during a medical procedure called rapid sequence intubation. This procedure involves inserting a tube into a person’s airway to help them breathe, and it can sometimes cause the heart rate to change. The trial aims to understand if opioids can help manage these heart rate changes during the procedure.

Gastroesophageal Reflux Disease (GERD) – This condition occurs when stomach acid frequently flows back into the tube connecting your mouth and stomach, known as the esophagus. This backwash, or acid reflux, can irritate the lining of your esophagus. Over time, the repeated exposure to stomach acid can lead to inflammation and damage to the esophageal lining. Symptoms often include heartburn, regurgitation of food or sour liquid, and difficulty swallowing. The disease can progress to more severe forms, such as esophagitis or Barrett’s esophagus, if left unmanaged. Lifestyle factors, such as diet and weight, can influence the severity and progression of GERD.

Trial ID:

2022-501500-10-00

NCT ID:

NCT05384665

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Impact of Sufentanil Citrate and Remifentanil on Heart Rate During Rapid Sequence Intubation in Patients Over 55 with High Anesthesia Risk

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?