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Study on Airway Changes in Patients with Residual Neuromuscular Blockade Using Sugammadex and Rocuronium Bromide

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 studying the effects of a condition known as residual neuromuscular blockade. This condition can occur after surgery when certain medications used to relax muscles during the procedure are still affecting the body. The study will use two medications: Sugammadex and Rocuronium Bromide. Sugammadex is a medication that helps reverse the effects of muscle relaxants, while Rocuronium Bromide is a muscle relaxant used during surgeries.

The purpose of the study is to observe changes in the size of the upper airway, specifically the area behind the tongue, during and after the effects of these muscle relaxants. The study will measure how the airway size changes when the muscle relaxants are still active and after they have been reversed. This is done by measuring the airway in terms of its cross-sectional area, which is the size of the airway opening, during breathing in and out.

Participants in the study will receive these medications through an injection into a vein, known as an intravenous injection. The study will monitor the changes in the airway size by using a method that measures the area in pixels, which is a unit of measurement for digital images. The study aims to understand how these medications affect the airway and ensure that patients can breathe comfortably after surgery. The study will take place over a short period, with the maximum treatment period being one day.

The research process

The trial runs in 6 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 (18-65 years), health status (ASA 1-3), and body mass index (BMI 18.5-25).

    Participants must be scheduled for surgeries lasting at least 30 minutes, requiring a breathing tube, and will be positioned lying on their back.

  2. Step 2

    Administration of muscle relaxants

    During the procedure, a muscle relaxant called rocuronium bromide is administered through an intravenous injection. This helps in relaxing the muscles for the surgery.

  3. Step 3

    Measurement of airway areas

    The size of the upper airway is measured in pixels during different phases of breathing (inspiration and expiration) while under the effect of the muscle relaxant.

    These measurements are taken at various levels of muscle relaxation, known as train of four (TOF) values.

  4. Step 4

    Reversal of muscle relaxation

    After the surgery, the effects of the muscle relaxant are reversed using sugammadex, administered intravenously.

    This medication helps restore normal muscle function.

  5. Step 5

    Post-reversal measurement

    Following the reversal, the size of the upper airway is measured again to observe any changes compared to the initial measurements taken before the administration of the muscle relaxant.

  6. Step 6

    Completion of participation

    Participation in the study concludes after the final measurements are taken and all necessary data is collected.

Who can join the trial?

7 criteria

  • Age between 18 and 65 years old.
  • Health status classified as ASA 1-3. This means the patient is either healthy or has mild to moderate health issues.
  • Body Mass Index (BMI) between 18.5 and 25, which indicates a normal body weight.
  • Both men and women can participate, with equal numbers from each gender.
  • The surgery must last at least 30 minutes.
  • The procedure requires intratracheal intubation, which is when a tube is placed into the windpipe to help with breathing during surgery.
  • Patients must be in a supine position, meaning they are lying on their back.

Who cannot join the trial?

3 criteria

  • Individuals who are not within the specified age range for the study.
  • Individuals who are part of a vulnerable population, which means groups that might need special protection or care.
  • Individuals who do not meet the specific health conditions required for the study.
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Investigated drugs

  • Muscle Relaxants

    are medications used to relax muscles during surgery or other medical procedures. They help in reducing muscle movement and making it easier for doctors to perform certain procedures. In this trial, muscle relaxants are used to study their effects on the airway's cross-sectional areas.

  • Reversal Agents

    are medications used to reverse the effects of muscle relaxants. After the procedure, these agents help restore normal muscle function by counteracting the muscle relaxants, allowing the patient to regain muscle control and normal breathing.

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 currently well-established in medical practice and literature as a reliable agent for this purpose. The main therapeutic indication for Neostigmine is to counteract residual neuromuscular blockade, which can occur after the use of muscle relaxants during surgery. At the molecular level, Neostigmine works by inhibiting the enzyme acetylcholinesterase, which increases the levels of acetylcholine at the neuromuscular junction, thereby improving muscle contraction. It is classified pharmacologically as a cholinesterase inhibitor.

Investigated diseases

Residual Neuromuscular Blockade – This condition occurs when muscle relaxants used during surgery do not fully wear off after the procedure, leading to weakened muscle function. It can affect the muscles involved in breathing and swallowing, potentially causing difficulty in these actions. The condition is typically identified by measuring the function of specific muscles, often using a technique called train-of-four (TOF) monitoring. As the effects of the muscle relaxants diminish, muscle strength gradually returns. The condition is temporary and resolves as the body metabolizes the remaining muscle relaxants.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519777-19-00Protocol codeAITT 2022/5Estimated enrolment75 patientsSponsorUniversity Of Debrecen

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