AuthorisedTherapeutic use (Phase IV)Interventional

Incidence and severity of postoperative delirium associated with Dexmedetomidine sedation during femur osteosynthesis in the elderly population

Older adults who have surgery to fix a broken thigh bone or hip sometimes experience sudden confusion afterwards. This temporary state is called postoperative delirium. It can cause memory loss, agitation, or sleepiness, making recovery slower and more distressing for patients and families. In this study, researchers want to see if a calming medicine called Dexdor works better than a standard sedative called propofol at preventing this confusion. Both medicines are already widely used in hospitals to keep patients relaxed and comfortable during operations. Participants will receive one of the two medicines while their bone is being repaired. The medical team will then closely monitor their recovery, pain levels, and mental clarity on the hospital ward. The findings could help doctors choose safer sedation methods for older patients in the future.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Enrolment target

Start

31 Aug 2026

Postoperative delirium

What is this study about?

Having an operation can be stressful, especially for older people who have broken a major bone like the femur (thigh bone). After this type of surgery, some patients develop a condition called postoperative delirium. This is a sudden, temporary state of severe confusion. A person with delirium might struggle to remember where they are, see things that are not there, or feel unusually restless or sleepy. While it usually passes, it can slow down recovery and be frightening for both the patient and their loved ones.

Doctors believe that the medicines used to relax or sedate patients during the operation might affect whether delirium happens. In this study, specialists are comparing two different sedative drugs: Dexdor (dexmedetomidine) and propofol. Propofol is a very common medicine used to keep patients asleep or calm during procedures. Dexdor is an alternative sedative that works in a different way and may cause less confusion when patients wake up.

During the study, patients having surgery to fix a broken thigh bone will receive one of these two medicines. Throughout the operation, doctors will carefully track how deep the sedation is, along with heart rate, blood pressure, and breathing. Afterwards, the care team will test the patient's memory and thinking to see if either medicine reduces the chance of confusion.

By comparing these treatments, doctors hope to find the kindest, safest way to keep older adults comfortable during surgery. If one medicine clearly reduces confusion, it could change hospital guidelines and help thousands of future patients recover more smoothly.

Key takeaways

The study tests whether Dexdor or propofol is better at preventing confusion after thigh bone surgery.
Postoperative delirium is a common, upsetting form of confusion that affects older surgical patients.
Both drugs are already approved and regularly used in hospital operating theatres.
All study monitoring happens during your normal hospital stay, with no extra visits needed.
Taking part is voluntary and will not delay your surgery or affect your usual NHS care.

Who may be eligible?

This trial focuses on older adults who need an operation to fix a broken thigh bone (femur). Because delirium is much more common after major joint and bone operations, the researchers are looking at patients who are scheduled for this specific procedure.

Men and women who need this operation may be invited to take part by their hospital surgical team. Because the surgery is often urgent, doctors will check whether the patient—or a family member if the patient is unable—can understand the study and give informed consent.

Patients may not be able to join if they have certain pre-existing heart conditions, severe ongoing brain disorders, or known allergies to the medicines being tested. The hospital team will review each person's medical history to ensure it is completely safe for them to take part.

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.

You are an older adult admitted to hospital.
You need surgery to repair a broken thigh bone (femur).
You are able to have intravenous sedation during your operation.
You do not have a known severe allergy to Dexdor or propofol.
You (or a representative) can give informed consent to take part.

Answer every question to see your result.

What does participation involve?

Taking part happens entirely during your planned hospital stay for thigh bone surgery, so there are no extra trips to the clinic. Before the operation, the care team will talk through the study and answer any questions. During the surgery, you will receive either Dexdor or propofol through a small drip in your vein, while specialists continuously monitor your vital signs, depth of sleep, and comfort.

After the operation, nurses and doctors will check in on you regularly on the ward. They will carry out brief, gentle memory and thinking checks to see if you are feeling confused or clear-headed. They will also make sure your pain is well controlled and take routine blood tests as part of your normal post-surgery care. Your involvement lasts only while you are recovering in the hospital, usually over a few days.

Potential risks and benefits

You might not get any direct personal benefit from taking part, but if you receive a medicine that lowers the risk of confusion, your recovery may feel easier. Your participation will also help doctors improve surgical care for other people in the future. Both medicines are already routinely used in hospitals, but like all sedatives, they can sometimes cause temporary side effects such as low blood pressure, a slower heart rate, or drowsiness. The anaesthetist will watch you closely at all times to manage any issues immediately. Taking part is completely voluntary, and choosing not to join will never change the quality of your NHS 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
Spain

Common questions

What is postoperative delirium?

It is a temporary state of mental confusion that can happen after surgery. People might feel disorientated, anxious, unusually quiet, or struggle to remember where they are. It usually clears up over a few days.

Can I choose which sedative medicine I receive?

No. A computer system decides at random which medicine you will be given. This is done to make sure the comparison between the two drugs is fair and scientifically sound.

Will being in this trial delay my surgery?

No. Fixing a broken thigh bone is an urgent operation. The study procedures fit into your planned surgery schedule and will not cause any delays to your care.

Will I feel pain during the procedure?

No. You will receive pain relief and anaesthetic just as you normally would. Keeping you safe, comfortable, and free from pain is the hospital team's top priority.

Can I leave the study if I change my mind?

Yes. You or your family can withdraw from the study at any time without giving a reason. Your hospital treatment and NHS care will carry on as normal.