In short
This article provides information about 2 ongoing clinical trials exploring medications to improve safety and comfort during endotracheal intubation procedures. These trials are testing pain-relieving medications called opioids in different patient groups, from newborn babies to older adults requiring surgery.
Clinical trial locations
- Belgium
- France
Study on Remifentanil and Sodium Chloride for Safe Intubation in Stable Newborns
This trial is investigating the medication remifentanil for helping newborn babies during the placement of a breathing tube. The procedure, called endotracheal intubation, involves inserting a tube into the windpipe to help with breathing.
Who can participate:
- Newborn babies who are stable in terms of blood pressure and heart function, without needing medications to support these functions
- Babies who are at least 26 weeks gestational age
- Babies who need planned (semi-elective) intubation
- Parents or legal guardians must provide written consent
Who cannot participate:
- Babies who are not stable in terms of blood circulation
- Babies who do not require semi-elective intubation
- Babies with known allergies to remifentanil
- Babies with any condition that doctors believe would make participation unsafe
What the trial aims to discover: The main goal is to find the right dose of remifentanil that provides effective sedation during the procedure while minimizing side effects. Researchers will observe how babies respond to the medication by monitoring their level of calmness and how smoothly the intubation process goes. Safety is carefully monitored by checking for changes in heart rate, breathing, or blood pressure. The study will also assess how quickly babies recover their normal breathing after the procedure.
Investigational medication: Remifentanil is the main medication being studied. It is given through an intravenous injection directly into a vein to help calm and relax the baby during the procedure. Sodium chloride solution may also be used to help with medication delivery.
Study on the Impact of Sufentanil Citrate and Remifentanil on Heart Rate During Rapid Sequence Intubation in Patients Over 55 with High Anesthesia Risk
This study focuses on how certain pain-relieving medications affect heart rate during rapid sequence intubation in older adults. This procedure is used when patients need to be put under general anesthesia quickly, particularly when they have a full stomach, which increases the risk of complications.
Who can participate:
- Patients over 65 years old with any health status, OR
- Patients aged 55 to 65 years old with an ASA score of 3 or higher (indicating significant health conditions)
- Patients undergoing urgent or scheduled surgery requiring general anesthesia with rapid sequence induction
- Patients considered to have a "full stomach" due to digestive problems, previous weight loss surgery, digestive blockages, or not following fasting guidelines
- Patients who provide written informed consent
- Patients affiliated with a French social security system
Who cannot participate:
- Patients younger than 55 years old
- Patients aged 55-65 with an ASA score greater than 3
- Patients who do not require rapid sequence induction
- Patients who are not considered to have a full stomach
What the trial aims to discover: The primary objective is to understand how opioid medications affect heart rate during the intubation process. Researchers will closely monitor heart rate changes from the moment patients enter the operating room until the end of the intubation. The study is designed as double-blind, meaning neither participants nor researchers know which medication each patient receives, ensuring unbiased results. Additional observations include changes in blood pressure and any side effects that may occur.
Investigational medications: The trial is testing three substances: sufentanil citrate, remifentanil, and sodium chloride. Sufentanil citrate and remifentanil are both opioids, which are strong pain-relieving medications commonly used during surgery. Sodium chloride is a simple salt solution used in medical settings. All medications are given through intravenous injection directly into the bloodstream.
Summary
These two clinical trials represent different approaches to improving the safety and comfort of intubation procedures across age groups. The Belgian study focuses on finding the optimal sedation dose for vulnerable newborns, while the French study examines heart rate management in older adults with higher surgical risks.
Both trials share a common interest in the medication remifentanil, highlighting its potential importance in intubation procedures. The studies are being conducted in different European countries, with Belgium hosting research on neonatal care and France focusing on older adult surgical patients. Each trial carefully monitors vital signs and side effects to ensure patient safety while gathering important data that could improve clinical practice in the future.
