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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 4

    Surgery (femur osteosynthesis)

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

  5. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

  • Dexmedetomidine

    It is given as an intravenous infusion of a clear solution that is mixed into a drip line. The drug is approved and commonly used for sedation of patients in intensive care and during procedures, and its safety is well documented in medical literature. It works by activating special receptors called alpha‑2 receptors in the brain, which calm nerve signals and reduce anxiety and pain. Dexmedetomidine belongs to the class of selective alpha‑2 adrenergic agonists and is mainly used to provide calm, cooperative sedation.

  • Propofol

    It is administered as an intravenous emulsion that is injected or infused through a vein. Propofol is a widely accepted anesthetic agent with extensive use for induction and maintenance of general anesthesia, and it is well studied in clinical research. The medication enhances the effect of a brain chemical called GABA, which slows down brain activity and produces sleep‑like sedation. Propofol is classified as a short‑acting intravenous anesthetic and is primarily used for anesthesia and procedural sedation.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2025-523070-16-00Estimated enrolment80 patientsSponsorFundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

sourced from the EU Clinical Trials Register and site verification

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