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

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What is this study about?

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.

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.

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.

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.

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).

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway

Other Sites

Site Name City Country Status
St. Olavs Hospital HF Trondheim Norway
Universitetssykehuset Nord-Norge HF Tromsø Norway
Hisck Busxke Hb Bergen Norway

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Recruiting
17.01.2022

Trial locations

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.

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.

Trial ID:
2023-510212-39-00
NCT ID:
NCT05029050
Trial Phase:
Human Pharmacology (Phase I) – Other

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