Postoperative Delirium Incidence and Severity in Patients ≥75 Years Undergoing Femur Osteosynthesis Sedated with Dexmedetomidine vs Propofol

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What is this study about?

The study looks at older adults (over 75 years) who have had surgery to repair a broken thigh bone called femur osteosynthesis. After this type of surgery, many patients can develop a confused state known as postoperative delirium. The trial compares two medicines used to keep patients calm during the operation: one is dexmedetomidine, given through a vein, and the other is propofol, also given by vein.

The purpose of the study is to see how severe and how often the confusion occurs when the first medicine is used compared with the second. Participants will receive one of the two medicines while under anesthesia, and after surgery they will be watched for several days to record any signs of confusion, how deep the sedation was, and basic health information such as blood pressure and pain levels.

Doctors will use simple tools such as a sleepiness score called the RASS scale and a monitor that measures brain activity called BIS to describe how sleepy the patient is. Blood tests and routine checks will also be done, and pain will be measured with a standard pain rating. The information collected will help understand whether one medicine leads to less confusion after this type of surgery.

1 enrollment and consent

after agreeing to join the study, you sign a consent form that explains the purpose of the research and what will be required of you.

2 baseline assessment

the study team records your medical history, current medications, and performs basic laboratory tests such as hemoglobin, electrolytes, blood glucose, and c‑reactive protein.

a brief evaluation is done to determine if you have any signs of postoperative delirium before the surgery.

3 pre‑operative preparation

you receive intrathecal (spinal) anesthesia, which numbs the area of the surgery while you remain awake.

standard monitoring of blood pressure, heart rate, oxygen saturation, and carbon dioxide levels is applied.

4 surgery (femur osteosynthesis)

the surgical team repairs the broken femur using metal hardware to hold the bone fragments together.

5 intra‑operative sedation

during the operation you receive a continuous intravenous (iv) infusion to keep you calm and comfortable.

if you are assigned to the dexmedetomidine group, a solution containing 100 µg per milliliter of dexmedetomidine is infused; the exact rate is adjusted by the anesthesiologist to maintain the desired level of sedation.

if you are assigned to the propofol group, a solution containing 20 mg per milliliter of propofol is infused; the infusion rate is similarly adjusted to achieve appropriate sedation.

both medications are delivered through an iv line directly into a vein.

6 immediate postoperative monitoring

after the surgery you are taken to a recovery area where nurses monitor your vital signs, oxygen level, and depth of sedation using the rass scale (a simple rating from -5 to +4).

any episodes of agitation or the need for restraints are recorded.

7 post‑operative delirium assessment

during the days following surgery, trained staff evaluate you regularly for signs of postoperative delirium using a standardized questionnaire.

the severity and course of any delirium are documented each day until it resolves or the hospital stay ends.

8 pain management

pain is assessed using a simple pain score, and appropriate analgesics are given as needed.

the amount and type of pain medication are recorded as part of the study data.

9 discharge and follow‑up

when you are medically ready, you are discharged home with instructions for any further assessments that may be required by the study.

Who Can Join the Study?

Age 75 or older: you must be at least 75 years old.
You must have had surgery to fix a broken thigh bone, known as a femur fracture.
The surgery must have been performed using intradural anesthesia (medicine placed near the spinal cord to block pain) together with sedation (medicine that keeps you relaxed or lightly sleepy).
The operation must have been done as a deferred emergency, meaning it was performed within 48 to 72 hours after the injury.
Both men and women are eligible to join the study.

Who Cannot Join the Study?

Patient refuses to take part or cannot cooperate with the study procedures.
Known allergy (a harmful reaction) to dexmedetomidine or propofol, or any medical reason that makes using these medicines unsafe.
Presence of severe psychiatric (mental health) or cognitive (thinking and memory) disorders.
Participation in another research study that could interfere with this study.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hotrslus Clfjzd Dq Bqkpvajja	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.09.2026

Trial locations

Investigated Drugs:

Dexmedetomidine is a medication given through an IV line to keep patients calm and comfortable after surgery. In this study it was used as the test drug to see how well it could prevent or reduce delirium – a confused mental state – in older adults who had surgery for a broken thigh bone.

Propofol is another IV medication that makes patients sleepy and is often used during surgery. In this trial it served as the comparison drug, allowing researchers to see if dexmedetomidine works better, worse, or the same as propofol in preventing postoperative delirium in the same group of elderly patients.

Investigated Diseases:

Postoperative delirium

Postoperative delirium – A sudden change in mental status that occurs after a surgical procedure, marked by reduced attention, disorganized thinking, and altered perception. It often appears within the first few days following surgery and can fluctuate in severity from hour to hour. The condition may progress from mild confusion to more pronounced disorientation before gradually improving over several days. Factors such as age, type of anesthesia, and surgical stress can influence its development and course.

Trial ID:

2025-523070-16-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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