Study on Ephedrine and Rocuronium for Faster Muscle Relaxation in Patients Aged 80 and Above Undergoing Elective Surgery

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What is this study about?

This clinical trial is focused on patients aged 80 years and older who are scheduled for elective surgery, which is a planned operation. The study is investigating the use of a medication called ephedrine, specifically in the form of an injection solution, to see if it can help reduce the time it takes for another medication, rocuronium, to start working. Rocuronium is commonly used during surgeries to relax the muscles, making it easier for doctors to perform procedures that require general anesthesia and intubation, which is the insertion of a tube into the windpipe to help with breathing.

The purpose of the study is to determine how quickly rocuronium begins to work after administering ephedrine. Participants in the study will receive either ephedrine or a placebo, which in this case is a saline solution, through an intravenous injection. The study will monitor the time it takes for rocuronium to take effect, as well as other factors such as the conditions for intubation and any changes in heart rhythm or blood pressure during the start of anesthesia.

The study is designed to be completed over a short period, with participants receiving the treatment on the day of their surgery. The results will help doctors understand if using ephedrine can improve the effectiveness of rocuronium in elderly patients undergoing surgery. This information could potentially lead to better management of anesthesia in older adults, ensuring safer and more efficient surgical procedures.

1 joining the study

Participation begins after providing informed consent and meeting the eligibility criteria. Participants must be 80 years or older, scheduled for elective surgery with anesthesia lasting more than one hour, and classified as ASA physical status I to III. Understanding of Danish is required.

2 preparation for surgery

Before surgery, participants will be prepared for general anesthesia, which includes intubation and the use of a muscle relaxant called rocuronium.

3 administration of study medication

Participants will receive an intravenous injection of either ephedrine at a dose of 0.15 mg per kilogram of body weight or a saline solution. This is done to study the effect of ephedrine on the onset time of rocuronium.

4 monitoring during anesthesia

During the induction of anesthesia, the time taken for rocuronium to achieve its full effect will be measured. This is known as the time to TOF 0, which refers to the time from the end of rocuronium administration until the absence of muscle response.

Intubating conditions will be assessed using specific scales, and any new cardiac arrhythmias occurring within 15 minutes after administration of ephedrine or saline will be recorded.

Changes in blood pressure from before induction to immediately after intubation will also be monitored.

5 post-anesthesia evaluation

After the procedure, the time taken for muscle response to return to 90% of normal (TOF 0.9) will be evaluated.

Who Can Join the Study?

Patients must be 80 years old or older.
Patients need to provide informed consent, which means they agree to participate after understanding the study details.
Patients should be scheduled for elective surgery. This means a planned surgery that is not an emergency, with anesthesia expected to last more than one hour.
Patients must be under general anesthesia with intubation. This means they will be fully asleep and have a tube placed in their airway to help them breathe during surgery.
Patients will receive a medication called rocuronium during the procedure.
Patients should have an American Society of Anesthesiologists (ASA) physical status classification of I to III. This is a way to describe a patient’s overall health, with I being healthy and III having more serious health issues.
Patients must be able to read and understand Danish.

Who Cannot Join the Study?

Patients who are not scheduled for elective surgery. Elective surgery is a planned surgery that is not an emergency.
Patients who are younger than 80 years old.
Patients who are part of a vulnerable population. A vulnerable population includes groups of people who may need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.11.2024

Trial locations

Investigated drugs:

Ephedrine is a medication used in this study to potentially speed up the onset time of another medication. It is often used to increase blood pressure and improve breathing. In this trial, it is being tested to see if it can help the other medication work faster in elderly patients.

Rocuronium is a medication used to relax muscles during surgery or other medical procedures. It helps make it easier for doctors to perform certain procedures by preventing muscle movement. In this study, researchers are looking at how quickly it starts working when used with ephedrine in elderly patients.

Elective Surgery – Elective surgery refers to a planned, non-emergency surgical procedure that is scheduled in advance. Unlike urgent surgeries, elective surgeries are not immediately necessary to save a life or prevent serious harm. These procedures can range from cosmetic surgeries to operations for chronic conditions that are not life-threatening. The progression of elective surgery involves pre-operative planning, the surgical procedure itself, and post-operative recovery. Patients typically undergo a series of evaluations and preparations before the surgery to ensure they are fit for the procedure. Recovery time and outcomes can vary depending on the type of surgery and the individual patient’s health.

Trial ID:

2024-517933-42-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Ephedrine and Rocuronium for Faster Muscle Relaxation in Patients Aged 80 and Above Undergoing Elective Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?