Study on Reversing Muscle Relaxation in Elderly Patients (75+) Using Sugammadex or Neostigmine/Glycopyrrolate During Laparoscopic Surgery

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What is this study about?

This clinical trial is focused on studying the effects of two different medications used to reverse muscle relaxation in elderly patients who are undergoing surgery. The study involves patients aged 75 years and older who are having surgery with the help of a robot, a procedure known as laparoscopic robot-assisted surgery. During such surgeries, patients are given medications to relax their muscles, and this study aims to compare two medications that help reverse this muscle relaxation after the surgery is completed.

The two medications being studied are neostigmine combined with glycopyrrolate, and sugammadex. Neostigmine and glycopyrrolate are given together as a solution for injection, while sugammadex is also given as a solution for injection. The purpose of the study is to determine which medication works faster in reversing the muscle relaxation. The study is designed to be “blinded,” meaning that neither the patients nor the researchers know which medication is being given to each patient, to ensure unbiased results.

Participants in the study will receive either neostigmine/glycopyrrolate or sugammadex after their surgery. The researchers will then measure how quickly the patients’ muscle function returns to normal. The study will also monitor for any signs of muscle weakness or other side effects after the medication is given. The goal is to find out if sugammadex provides a quicker recovery from muscle relaxation compared to neostigmine/glycopyrrolate in elderly patients. This information could help improve recovery times and outcomes for patients undergoing similar surgeries in the future.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose and procedures. You will need to provide your consent to participate, confirming that you understand the study and agree to take part.

2 preparation for surgery

You will be scheduled for robotic-assisted laparoscopic surgery under general anesthesia. This involves being put to sleep for the operation, and a breathing tube will be used to help you breathe during the procedure.

3 administration of muscle relaxant

During the surgery, a medication called rocuronium will be used to relax your muscles. This is a standard part of the procedure to ensure the surgery can be performed safely and effectively.

4 reversal of muscle relaxation

After the surgery, you will receive one of two medications to help reverse the muscle relaxation. You will either receive neostigmine/glycopyrrolate at a dose of 50 micrograms per kilogram of your body weight or sugammadex at a dose of 2 milligrams per kilogram. Both medications are given through an injection into a vein.

5 monitoring recovery

Your recovery will be closely monitored to assess how quickly your muscle function returns to normal. This includes checking your ability to grip with your hand, lift your head, and follow objects with your eyes. These checks will be done upon arrival at the post-anesthesia care unit and again after 90 minutes.

6 additional monitoring

You will be observed for any signs of breathing difficulties or changes in heart rhythm for up to 180 minutes after receiving the reversal medication. This is to ensure your safety and to address any potential issues promptly.

7 completion of trial participation

Once you have recovered sufficiently and are ready to leave the operating room, your participation in the trial will be complete. You will continue to receive standard post-operative care as needed.

Who Can Join the Study?

Patients must be 75 years old or older.
Patients must give their informed consent, which means they agree to participate after understanding the study.
Patients must be scheduled for robotic-assisted laparoscopic surgery under general anesthesia. This involves using a robot to help perform surgery through small cuts, and the patient will be asleep and not feel pain during the procedure.
Patients must have a physical status classification from the American Society of Anesthesiologists (ASA) of I to IV. This is a system that describes a patient’s overall health, where I means healthy and IV means having severe health issues.
Patients must be able to read and understand Danish.

Who Cannot Join the Study?

Patients who are not undergoing laparoscopic robot-assisted surgery. This is a type of surgery that uses small incisions and robotic tools to perform the operation.
Patients who are younger than 75 years old.
Patients who are part of a vulnerable population. This means groups of people who might need special protection or care, such as those with certain disabilities or conditions.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Bispebjerg Hospital	Copenhagen	Denmark

Other Sites

Site Name	City	Country	Status
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.06.2023

Trial locations

Investigated drugs:

Neostigmine is a medication used to help reverse the effects of certain muscle relaxants that are given during surgery. It works by increasing the levels of a natural chemical in the body that helps muscles contract. In this study, it is used in combination with another medication to help elderly patients recover their muscle strength after surgery.

Glycopyrrolate is often used alongside neostigmine to help reduce some of the side effects that neostigmine might cause, such as excessive saliva or slow heart rate. It helps balance the effects of neostigmine, making the recovery process smoother for patients.

Sugammadex is a medication that is also used to reverse the effects of certain muscle relaxants used during surgery. It works differently from neostigmine by directly binding to the muscle relaxant, which helps the body remove it more quickly. This can lead to a faster recovery of muscle strength after surgery, especially in elderly patients.

Residual Neuromuscular Blockade – Residual neuromuscular blockade occurs when muscle relaxants used during surgery continue to affect the body after the procedure is completed. This condition can lead to weakened muscle function, making it difficult for patients to perform tasks such as gripping objects, lifting their head, or protruding their tongue. Patients may also experience double or blurred vision and have trouble tracking objects with their eyes. The condition is typically temporary, but it can cause discomfort and delay recovery. It is important to monitor patients for signs of this condition in the post-anesthesia care unit.

Trial ID:

2023-504230-21-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Reversing Muscle Relaxation in Elderly Patients (75+) Using Sugammadex or Neostigmine/Glycopyrrolate During Laparoscopic Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?