RecruitingNAINTERVENTIONAL

Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk

This study aims to see if closely watching how much pain medication and sleep-inducing drugs (like anaesthetics) patients receive during surgery can improve their recovery. Specifically, it's focused on older patients (over 75) who are at high risk for complications after their operation. When blood pressure drops too low during surgery, it can sometimes cause serious issues like organ damage or even increase the risk of dying, especially for these vulnerable patients. This drop in blood pressure can sometimes be linked to the depth of anaesthesia and the amount of pain relief given. The study will compare patients receiving standard care with those whose anaesthesia is guided by special monitoring for pain and sedation levels. The goal is to see if this guided approach can reduce common problems linked to low blood pressure during surgery.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrolment target

1,132

Start

12 Oct 2023

Estimated completion

01 Feb 2028

Sedation and Analgesia Monitoring

What is this study about?

When you have surgery, doctors give you medicines to make sure you don't feel pain (analgesics) and to put you to sleep (hypnotics, part of anaesthesia). Sometimes, during surgery, a patient's blood pressure can drop too low. This is called 'intraoperative hypotension'. While doctors try their best to prevent this, for some patients, especially those who are older or have other health issues, low blood pressure during surgery can unfortunately lead to problems like organ damage or a longer recovery.

The amount of pain relief and sleep-inducing medicine given can sometimes contribute to this drop in blood pressure. We know that if doctors carefully watch and adjust these medicines, it might help prevent blood pressure from becoming too low. Some previous research has suggested that using special monitors to guide anaesthesia can reduce the amount of medicine needed during surgery. However, we don't fully know yet if this monitoring directly leads to fewer serious problems after surgery, such as organ damage or even a risk to life.

This study wants to explore whether using a combined monitoring system—one that helps doctors carefully adjust both the pain relief and sleep medicines—can lead to better outcomes. It's particularly focused on patients who are considered to be at a higher risk of complications after surgery. By comparing this new monitoring approach with standard care, the researchers hope to understand if it can help reduce the common problems that can arise from low blood pressure during an operation.

Key takeaways

This study aims to improve safety for older, high-risk patients during surgery.
It tests if careful monitoring of anaesthesia medicines can prevent problems like organ damage.
The study compares standard care with a new monitoring approach.
Eligibility primarily focuses on patients over 75 with certain health conditions.
Your medical care won't be affected if you choose not to participate or withdraw.

Who may be eligible?

To join this study, you would generally need to be over 75 years old and planning to stay in hospital for more than two days after your surgery. You would also need to have at least one of several health conditions that put you at a higher risk for complications after surgery. These could include conditions like heart disease, a history of stroke, significant breathing problems, severe kidney issues, diabetes requiring insulin, or active cancer. Your surgery must be a high-risk operation under general anaesthesia where you'll receive a combination of sleep-inducing and pain-relieving medications.

There are also reasons why you wouldn't be able to join. For example, if you currently have a very serious heart condition like acute heart failure or a recent heart attack, or if you have a severe lung infection or acute stroke, you wouldn't be suitable. Similarly, if you're having heart surgery, open-chest surgery, or if your anaesthesia plan involves certain specific medications (like high doses of ketamine or continuous infusions of lidocaine or dexmedetomidine), you wouldn't be able to participate.

Finally, you must be able to understand the study and agree to take part by signing a consent form. People who are under guardianship or unable to understand the study details would not be able to join.

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 over 75 years old?
Will you be staying in the hospital for more than 48 hours after your operation?
Do you have a health condition like heart disease, previous stroke, severe kidney problems, or diabetes treated with insulin?
Is your scheduled surgery a high-risk operation under general anaesthesia?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will either receive the standard anaesthesia care that your doctors would normally provide, or your anaesthesia will be guided by special monitors that help your anaesthetist carefully adjust your sleep and pain medications. This guidance will happen only during your surgery. After your surgery, doctors will continue to check on your recovery, just as they normally would. The study aims to see if this guided approach makes a difference to your recovery outcomes, particularly in preventing problems that can arise from low blood pressure during the operation. There are no additional visits or assessments required beyond a typical recovery from surgery.

Potential risks and benefits

Participating in this study might mean that your anaesthesia during surgery is more finely tuned, which could potentially reduce the risk of low blood pressure and related complications after your operation. However, there's also a chance that it might not lead to any extra benefit compared to standard care. As with any medical procedure, there are always inherent risks with surgery and anaesthesia, which your doctors will discuss with you. Taking part in the study doesn't add significantly to these risks, as both groups receive careful medical attention. You are entirely free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (18)

Chu D'Amiens Picardie
Verified postcode
Amiens, France· Recruiting
Clinique Victor Pauchet
Verified postcode
Amiens, France· Recruiting
Chru de Besancon
Verified postcode
Besançon, France· Not yet recruiting
Polyclinique Bordeaux Nord Aquitaine
Verified postcode
Bordeaux, France· Recruiting
Chu Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Not yet recruiting
Chu de Grenoble
Verified postcode
Grenoble, France· Not yet recruiting
Chu de Lille
Verified postcode
Lille, France· Recruiting
APHM - Centre Hôpital Marseille Nord
Verified postcode
Marseille, France· Not yet recruiting
Chu de Nantes
Verified postcode
Nantes, France· Not yet recruiting
Chu de Nimes
Verified postcode
Nîmes, France· Recruiting
Hopital Bichat Claude Bernard
Verified postcode
Paris, France· Recruiting
Chu Lyon Sud
Verified postcode
Pierre-Bénite, France· Recruiting

Common questions

What is 'intraoperative hypotension'?

It means your blood pressure drops too low during surgery.

Why is low blood pressure during surgery a concern?

It can sometimes lead to complications like damage to organs, especially in high-risk patients.

What kind of monitoring are they using?

They're using special devices to help doctors precisely adjust sleep-inducing and pain-relieving medicines during surgery.

What is 'high-risk surgery'?

It refers to operations where there's a higher chance of complications, often because of the type of surgery or the patient's existing health conditions.

Will I know which group I'm in?

Studies like this often use a 'blinded' approach, meaning neither you nor your care team might know until after the study is complete, to ensure fair results.

How to find out more

David CHARIER, MD, PhD

david.charier@chu-st-etienne.fr +33.4.77.82.85.65 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.