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Study on Dexmedetomidine and Clonidine Hydrochloride to Prevent Delirium in Patients Undergoing Open Heart Surgery

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What is this trial about?

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

This clinical trial is focused on preventing delirium and cognitive decline in patients undergoing open heart surgery. Delirium is a sudden change in mental status that can cause confusion and reduced awareness of the environment. The study will use two medications, dexmedetomidine and clonidine hydrochloride, which are known as alpha-2 adrenergic receptor agonists. These medications are being tested to see if they can help prevent delirium after surgery. Some participants will receive a placebo, which is a substance with no active medication, to compare the effects.

The purpose of the study is to explore whether these medications can effectively prevent delirium in patients who are 70 years or older and are undergoing heart surgery with the use of a heart-lung machine. The study will involve administering the medications through an intravenous infusion, which means they will be given directly into a vein. The treatment period will last for a maximum of two days. Participants will be monitored for any changes in their mental status and overall health before and after the surgery.

Throughout the study, researchers will assess various factors, including the number of days participants experience delirium, the severity of delirium, and any changes in cognitive function. They will also look at the overall health status of participants over time. The study aims to provide valuable insights into the potential benefits of using these medications to improve recovery and mental health outcomes after heart surgery.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on age (70 years or older) and acceptance for specific types of heart surgery. Informed consent is required.
Step 2
Preoperative assessment
Before surgery, cognitive function and health status are assessed using various tests, including the Montreal Cognitive Assessment and EQ-5D-5L questionnaire.
Step 3
Medication administration
During the trial, medications such as dexmedetomidine or clonidine are administered through intravenous infusion. The specific dosage and frequency are determined by the study protocol.
Step 4
Surgery and immediate postoperative period
The surgery is performed, and the immediate postoperative period is monitored for signs of delirium using criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5).
Step 5
Postoperative monitoring
Postoperative monitoring includes assessing the incidence of delirium, coma, and other health indicators using tools like the Richmond Agitation Sedation Scale and Confusion Assessment Method for Intensive Care Units-7.
Step 6
Follow-up assessments
Follow-up assessments occur 1 and 6 months after surgery to evaluate changes in cognitive function, health status, and frailty. These assessments use various tests and questionnaires.
Step 7
End of participation
Participation concludes with a final assessment of health and cognitive function. The study aims to prevent postoperative delirium and assess the safety and tolerability of the medications used.

Who can join the trial?

6 criteria

The participant must be at least 70 years old when they sign the consent form.
The participant must be scheduled for cardiac surgery that uses a heart-lung machine, which helps circulate blood during the surgery. This surgery can include:
- Coronary bypass grafting: A procedure to improve blood flow to the heart.
- Valve replacement or repair: Fixing or replacing the heart's tricuspid, mitral, or aortic valves.
- Surgery on the ascending aorta: The large blood vessel that carries blood away from the heart.
- A combination of any of these procedures.
- The participant must be able to understand and sign the informed consent, which is a document explaining the study and what is expected from participants.

Who cannot join the trial?

3 criteria

Individuals who are not within the specified age range for the study.
Individuals who do not belong to the specified clinical trial groups.
Individuals who are not part of the vulnerable population selected for the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Helse Bergen HF
Verified
Bergen, Norway
Oslo Universitetssykehus HF
Verified
Oslo, Norway
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

Trial locations

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Investigated drugs

Alpha 2 Adrenergic Receptor Agonists are medications used in this trial to help prevent delirium and cognitive decline after open heart surgery. These medications work by stimulating specific receptors in the brain, which can help calm the nervous system and reduce the risk of confusion and memory problems after surgery.

What is already known about the treatment

Alpha 2 Adrenergic Receptor Agonists – These medications are administered orally or intravenously, depending on the specific formulation and patient needs. They are currently being studied in clinical trials for their potential to prevent delirium and cognitive decline following open heart surgery. The main therapeutic indication is the prevention of postoperative delirium. At the molecular level, these medications work by stimulating alpha-2 adrenergic receptors in the brain, which helps to reduce sympathetic nervous system activity and may have a calming effect. They are classified pharmacologically as alpha-2 adrenergic receptor agonists.

Investigated diseases

Delirium – Delirium is a sudden change in mental status characterized by confusion, disorientation, and difficulty focusing attention. It often occurs in hospitalized patients, especially after surgery, and can fluctuate in severity throughout the day. The condition may involve hallucinations, restlessness, or lethargy, and can be distressing for both the patient and their caregivers. Delirium is typically temporary, but it can last for days or weeks. It is important to identify and address any underlying causes, such as infections or medication effects, to help resolve the symptoms.