Study on Desflurane, Sevoflurane, and Propofol for Postoperative Delirium in Elderly Patients Undergoing Major Abdominal Surgery

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What is this study about?

This clinical trial is focused on understanding the effects of different anesthesia medications on a condition called postoperative delirium in elderly patients. Postoperative delirium is a state of confusion that can occur after surgery. The study involves patients who are 65 years or older and are undergoing major non-cardiac surgeries, which are surgeries not involving the heart but are considered moderate to high risk. The medications being studied are Desflurane, Sevoflurane, and Propofol. Desflurane and Sevoflurane are inhaled anesthetics, meaning they are breathed in as a vapor, while Propofol is given through an injection or infusion into a vein.

The purpose of the study is to compare how these three medications affect the likelihood of experiencing postoperative delirium within the first five days after surgery. The study is designed to be double-blinded, meaning neither the patients nor the researchers know which medication is being given to each patient, to ensure unbiased results. Patients will be randomly assigned to receive one of the three medications during their surgery. The study will also look at other outcomes, such as cognitive function after surgery, nausea and vomiting, and the need for additional oxygen after surgery.

Participants will be monitored closely during and after their surgery to assess the effects of the anesthesia. The study aims to provide valuable information on which anesthesia medication might be better for reducing the risk of postoperative delirium and other related complications in elderly patients undergoing major surgeries. This information could help doctors make better choices about anesthesia for older patients in the future.

1 joining the study

Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate after understanding the details of the study.

You must be at least 65 years old and scheduled for elective major noncardiac surgery that is expected to last at least 2 hours.

2 pre-surgery preparation

Before your surgery, you will be randomly assigned to receive one of three types of anesthesia: propofol, sevoflurane, or desflurane.

The anesthesia will be administered to help you remain unconscious and pain-free during the surgery.

3 surgery and anesthesia administration

During your surgery, the assigned anesthesia will be administered. Propofol will be given through an intravenous infusion, which means it will be delivered directly into your bloodstream through a vein.

Sevoflurane and desflurane will be given through inhalation, meaning you will breathe in the medication as a vapor.

4 post-surgery monitoring

After your surgery, you will be monitored for any signs of postoperative delirium within the first five days. This is a temporary state of confusion that can occur after surgery.

You will also be observed for any postoperative cognitive dysfunction, which refers to changes in memory or thinking skills, and for postoperative nausea and vomiting (PONV).

5 follow-up and recovery

Your recovery will be tracked, including the length of your stay in the intensive care unit (ICU) and the number of days you spend at home within the first 30 days after surgery.

Additional monitoring may include the administration of supplemental oxygen if needed and tracking of blood pressure during surgery.

Who Can Join the Study?

  • Provide written informed consent. This means you agree to participate in the study after being informed about all aspects of it.
  • Be at least 65 years old.
  • Be scheduled for an elective major noncardiac surgery. This means a planned surgery that is not related to the heart.
  • The estimated time for your surgery should be at least 2 hours.

Who Cannot Join the Study?

  • Patients who are not elderly.
  • Patients who are not undergoing moderate- to high-risk major non-cardiac surgery.
  • Patients who have a history of delirium (a sudden change in mental state that can cause confusion and reduced awareness of the environment).
  • Patients who are not able to give consent to participate in the study.
  • Patients who are part of a vulnerable population (groups that may have limited ability to protect their interests).
  • Patients who are not able to follow the study procedures.
  • Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Medizinische Universitaet Innsbruck Innsbruck Austria

Other Sites

Site Name City Country Status
Mcxxpay Utjfzpbbsn Ot Gadv Graz Austria

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
01.05.2023

Trial locations

Desflurane is a type of medication used to keep patients asleep during surgery. It is a gas that is inhaled through a mask or a breathing tube. In this trial, it is being used to see if it affects the chances of experiencing confusion or disorientation after surgery, which is known as postoperative delirium.

Sevoflurane is another medication used to maintain sleep during surgery. Like desflurane, it is also a gas that patients breathe in. The trial is investigating whether using sevoflurane during surgery has any impact on the likelihood of developing postoperative delirium in elderly patients.

Propofol is a medication that helps keep patients asleep during surgery, but unlike desflurane and sevoflurane, it is given through an injection into a vein. This trial is examining if propofol affects the chances of experiencing postoperative delirium in elderly patients after surgery.

Investigated diseases:

Postoperative Delirium – Postoperative delirium is a temporary state of confusion that can occur after surgery, particularly in elderly patients. It typically manifests within the first few days following the procedure. Symptoms include disorientation, difficulty focusing, and fluctuating levels of consciousness. The condition can vary in severity and may involve hallucinations or agitation. It is often influenced by factors such as the type of anesthesia used and the patient’s overall health. Recovery from postoperative delirium can take several days, with symptoms gradually diminishing.

Postoperative Cognitive Dysfunction – Postoperative cognitive dysfunction (POCD) is a decline in cognitive abilities such as memory, attention, and executive function following surgery. It is more common in older adults and can occur after both cardiac and non-cardiac surgeries. The condition may not be immediately apparent and can develop days or weeks after the procedure. POCD can affect daily functioning and quality of life, with symptoms ranging from mild to severe. The exact cause is not fully understood, but it is believed to be related to factors like anesthesia, inflammation, and stress from surgery. Recovery can vary, with some individuals experiencing improvement over time.

Postoperative Nausea and Vomiting – Postoperative nausea and vomiting (PONV) are common complications following surgery, characterized by feelings of nausea and episodes of vomiting. These symptoms can occur shortly after the procedure or develop over the following days. PONV is influenced by factors such as the type of surgery, anesthesia used, and individual patient characteristics. It can lead to discomfort, dehydration, and delayed recovery. The condition is typically self-limiting, with symptoms resolving as the body recovers from the effects of anesthesia and surgery. Management focuses on minimizing triggers and providing supportive care.

Trial ID:
2023-503717-30-00
Protocol code:
RAPIDII_01
Trial Phase:
Human Pharmacology (Phase I) – Other

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