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Study on Muscle Relaxation Reappearance in Patients Under General Anesthesia Using Glycopyrronium Bromide and Neostigmine Methylsulfate

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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 understanding the effects of a medication called Glycostigmin, which is a solution for injection containing two active substances: glycopyrronium bromide and neostigmine methylsulfate. The study is particularly interested in how these substances work together to reverse muscle relaxation during general anesthesia. Muscle relaxation is often used during surgeries to help keep the body still, and reversing this relaxation is important for recovery after the procedure.

The main purpose of the study is to find out how often muscle relaxation returns after it has been reversed with neostigmine. This is important because sometimes, even after the medication is given to reverse the muscle relaxation, the muscles might not fully regain their normal function right away. The study will monitor patients who are undergoing general anesthesia to see how their muscles respond after receiving the reversal medication.

Participants in the study will receive the medication through an intravenous infusion, which means it will be delivered directly into the bloodstream. The study will observe the effects of the medication over a short period to gather information on how well it works in preventing the reappearance of muscle relaxation. This research aims to improve the safety and effectiveness of reversing muscle relaxation during surgeries.

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, eligibility is confirmed based on criteria such as age between 18 and 65 years, a body mass index (BMI) of less than 35, and an ASA risk class of 1 or 2.

  2. Step 2

    Preparation for general anaesthesia

    Before undergoing general anaesthesia, preparation involves monitoring and ensuring all necessary conditions are met for the procedure.

  3. Step 3

    Administration of medication

    During the procedure, a solution for injection called Glycostigmin is administered through an intravenous infusion. This solution contains the active substances glycopyrronium bromide and neostigmine methylsulfate.

  4. Step 4

    Monitoring of neuromuscular blockade

    The main objective is to monitor the neuromuscular blockade during general anaesthesia, specifically observing the reappearance of muscle relaxation after reversal with neostigmine.

  5. Step 5

    Completion of the trial

    The trial is estimated to conclude by December 31, 2026. Throughout the trial, the primary endpoint is to determine the incidence of the reappearance of nondepolarizing neuromuscular block after reversal with neostigmine.

Who can join the trial?

4 criteria

  • Participants must be between the ages of 18 and 65 years old.
  • Participants should have a Body Mass Index (BMI) of less than 35. BMI is a measure that uses your height and weight to work out if your weight is healthy.
  • Participants should be classified as ASA risk class 1-2. This means they are considered to be in good health or have mild systemic disease. ASA stands for the American Society of Anesthesiologists, which provides a way to assess the fitness of patients prior to surgery.
  • Both male and female participants are eligible to join the study.

Who cannot join the trial?

8 criteria

  • Patients who have a known allergy or adverse reaction to **neostigmine** or any similar medications. **Neostigmine** is a drug used to reverse muscle relaxation.
  • Individuals with a history of **neuromuscular disorders**. These are conditions that affect the nerves and muscles, such as **myasthenia gravis**.
  • Patients who are currently taking medications that might interfere with the study drug. This includes certain antibiotics or other drugs that affect muscle function.
  • People with severe **kidney** or **liver disease**. These organs help process medications, and their impairment can affect how drugs work in the body.
  • Pregnant or breastfeeding women, as the effects of the study drug on the baby are not known.
  • Individuals who have participated in another clinical trial within the last 30 days. This is to ensure that previous treatments do not affect the study results.
  • Patients with a history of **substance abuse**. This refers to the misuse of drugs or alcohol, which can affect health and study outcomes.
  • Anyone who is unable to provide informed consent. This means they cannot understand the study details well enough to agree to participate.
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Investigated drugs

Neostigmine is a medication used to reverse the effects of certain muscle relaxants after surgery. It helps restore normal muscle function by increasing the levels of a chemical that stimulates muscle movement. In this trial, it is used to reverse neuromuscular blockade, which is a temporary paralysis of the muscles induced during general anesthesia.

What is already known about the treatment

Neostigmine – Neostigmine is administered intravenously and is used to reverse the effects of muscle relaxants after surgery. It is well-established in medical practice and literature as a reliable agent for this purpose. The main therapeutic indication for neostigmine is to counteract muscle relaxation, particularly after the use of nondepolarizing neuromuscular blockers during anesthesia. At the molecular level, neostigmine works by inhibiting the enzyme acetylcholinesterase, which increases the levels of acetylcholine at neuromuscular junctions, thereby restoring muscle function. It is classified pharmacologically as a cholinesterase inhibitor.

Investigated diseases

Nondepolarizing Neuromuscular Block – This condition occurs when certain medications are used to relax muscles during surgery or other medical procedures. These medications work by blocking the transmission of nerve signals to the muscles, preventing them from contracting. After the procedure, a drug like neostigmine is often used to reverse this muscle relaxation. However, in some cases, the muscle relaxation can reappear after initially being reversed. This can lead to temporary muscle weakness or difficulty in moving. The study focuses on understanding how often this reappearance occurs and the factors that might influence it.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517831-28-00Estimated enrolment120 patientsSponsorPirkanmaan hyvinvointialue

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