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Study on Esmolol Hydrochloride vs. Sufentanil Citrate for Recovery Quality in Patients Undergoing Laparoscopic Gallbladder Surgery with Anesthesia

Verified siteRegistered drugNo placebo
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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 patients undergoing a procedure called laparoscopic cholecystectomy, which is a minimally invasive surgery to remove the gallbladder. The study aims to compare two medications, Esmolol and Sufentanil, to see which one provides better comfort and recovery quality after the surgery. Both medications are given as injections during anesthesia, which is the process of using medicine to prevent pain during surgery. Esmolol is often used to manage heart rate and blood pressure, while Sufentanil is a strong pain reliever.

The purpose of the study is to evaluate whether using Esmolol is as effective as using Sufentanil for improving patient comfort after surgery. Participants will be randomly assigned to receive either Esmolol or Sufentanil during their anesthesia. After the surgery, the quality of recovery will be assessed using a questionnaire the day after the procedure. The study will also monitor other factors such as pain levels, any sore throat, changes in blood pressure, heart rate, and the need for additional medications during the operation.

The trial is designed to ensure that the recovery process is as comfortable as possible for patients undergoing this type of surgery. By comparing these two medications, the study aims to find the best approach to enhance recovery and overall patient experience after a laparoscopic cholecystectomy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either esmolol hydrochloride or sufentanil citrate during your surgery. This is to compare the effects of these medications on recovery quality after your procedure.

  2. Step 2

    Preparation for surgery

    Before your laparoscopic cholecystectomy, you will receive a solution for injection. This will be either esmolol hydrochloride or sufentanil citrate, depending on your group assignment. The medication will be administered through an injection.

  3. Step 3

    During surgery

    During the surgery, you will be under general anesthesia with a tube placed in your throat to help you breathe. The medication you received will help manage your comfort and recovery quality.

  4. Step 4

    Post-surgery recovery

    After the surgery, your recovery will be monitored. You will be asked to complete a quality of recovery questionnaire the day after your surgery to assess your comfort and recovery experience.

  5. Step 5

    Monitoring and follow-up

    Your recovery will be monitored for any side effects such as sore throat, changes in blood pressure, heart rate, or the need for additional pain medication. This monitoring helps ensure your safety and the effectiveness of the medication.

Who can join the trial?

6 criteria

  • Must be an adult patient.
  • Must be classified as ASA I to III. This means the patient is in a physical state ranging from healthy (I) to having mild to severe systemic disease (III).
  • Must have a planned outpatient cholecystectomy. This is a scheduled surgery to remove the gallbladder, and the patient will not stay overnight in the hospital.
  • Must undergo general anesthesia with orotracheal intubation. This means the patient will be put to sleep for the surgery, and a tube will be placed in the windpipe to help with breathing.
  • Must have signed their consent to participate in the study.
  • Must be affiliated with a social security system, meaning they have some form of health insurance or social health coverage.

Who cannot join the trial?

5 criteria

  • Patients who are not undergoing a laparoscopic cholecystectomy cannot participate. Laparoscopic cholecystectomy is a type of surgery to remove the gallbladder using small cuts and a camera.
  • Patients who are not receiving anesthesia with oro-tracheal intubation cannot participate. Oro-tracheal intubation is a procedure where a tube is placed through the mouth into the windpipe to help with breathing during surgery.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Both male and female patients are eligible, but those who do not identify as either cannot participate.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

  • Esmolol

    is a medication used in this trial to help manage heart rate and blood pressure during surgery. It works by slowing down the heart rate and relaxing the blood vessels, which can help improve the patient's comfort and recovery after surgery. In this study, Esmolol is being tested to see if it can provide similar comfort and recovery quality as another medication during anesthesia for a specific type of surgery.

  • Sufentanil

    is a strong pain relief medication used during surgery to help manage pain and improve patient comfort. It is an opioid, which means it works by blocking pain signals in the brain. In this trial, Sufentanil is being compared to Esmolol to see which medication provides better comfort and recovery quality for patients undergoing a specific surgical procedure.

What is already known about the treatment

  • Esmolol

    Esmolol is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials to see if it can improve recovery quality after surgery, specifically laparoscopic cholecystectomy, which is a type of gallbladder removal surgery. The main use of Esmolol in this context is to help manage heart rate and blood pressure during surgery, potentially reducing the need for other pain medications. At the molecular level, Esmolol works by blocking certain receptors in the heart, known as beta-adrenergic receptors, which helps to slow down the heart rate and lower blood pressure. It is classified as a beta-blocker, a type of medication commonly used to treat heart-related conditions.

  • Sufentanil

    Sufentanil is administered intravenously, meaning it is given directly into a vein through an injection. It is a well-established medication in the medical field, often used for pain management during and after surgeries, including laparoscopic cholecystectomy, which is a type of gallbladder removal surgery. Sufentanil is primarily used to provide pain relief and improve patient comfort during surgical procedures. At the molecular level, it works by binding to specific receptors in the brain and spinal cord, known as opioid receptors, which helps to block pain signals. It is classified as an opioid analgesic, a type of medication used to relieve severe pain.

Investigated diseases

Laparoscopic Cholecystectomy – Laparoscopic cholecystectomy is a surgical procedure to remove the gallbladder, a small organ located beneath the liver. This procedure is often performed when gallstones cause pain or infection. During the surgery, small incisions are made in the abdomen, and a camera and surgical tools are inserted to remove the gallbladder. The progression involves the initial formation of gallstones, which can lead to inflammation or infection of the gallbladder. Symptoms may include abdominal pain, nausea, and vomiting. The condition can progress to more severe complications if not addressed, but the surgery typically resolves the symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520282-31-00Protocol code87RI_24_0041Estimated enrolment120 patientsSponsorCentre Hospitalier Et Universitaire De Limoges

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