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Study on the Effect of Rocuronium Bromide, Sugammadex, and Suxamethonium Chloride for Adults with Respiratory Distress Requiring Emergency Tracheal Intubation

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 improving the process of emergency tracheal intubation, which is a procedure used to help patients breathe when they are experiencing severe breathing problems, known as respiratory distress. The study will use a combination of medications and techniques to see if they can reduce complications that might occur after the procedure. The medications involved in this study include Rocuronium, Sugammadex, and Suxamethonium. These are used to help relax the muscles during intubation, making the process smoother and potentially safer.

The purpose of the study is to evaluate whether this new strategy can decrease the number of complications that happen shortly after intubation. Participants in the study will receive either the new combination of treatments or the usual care. The study will observe the effects of these treatments on patients who need emergency intubation outside of a hospital setting. The trial will monitor the patients for any severe complications, such as low blood pressure, low oxygen levels, or other issues that might arise during the first hour after intubation.

Throughout the study, researchers will also look at how difficult the intubation process is, how long it takes to provide care outside the hospital, and the amount of medication needed after intubation. The study will follow patients until they are admitted to the hospital and will check their health status up to 28 days later. This research aims to find better ways to perform emergency intubations and improve patient outcomes.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon meeting the inclusion criteria, participation in the study begins. The criteria include being an adult patient (18 years or older) experiencing vital distress and requiring emergency endotracheal intubation, excluding those in cardiac arrest.

  2. Step 2

    Administration of medications

    The study involves the use of three medications administered intravenously. These are rocuronium bromide, sugammadex, and suxamethonium chloride. The specific dosages and frequency of administration are determined by the medical team based on individual patient needs.

  3. Step 3

    Intubation process

    The intubation process is optimized using a strategy that includes rocuronium, bag face-mask ventilation before intubation, and the use of a gum elastic bougie (GEB) as an aid. This strategy aims to reduce complications related to intubation.

  4. Step 4

    Monitoring for complications

    During the first hour after intubation, monitoring occurs for severe complications. These include cardiac arrest, low blood pressure, low oxygen levels, severe heart rhythm issues, pulmonary aspiration, incorrect tube placement, and unintentional removal of the tube.

  5. Step 5

    Assessment of intubation difficulty

    The difficulty of the intubation process is assessed using various scores and techniques. This includes the Intubation Difficulty Score and the Copenhagen score, as well as the use of alternative intubation techniques if necessary.

  6. Step 6

    Out-of-hospital care

    The duration and quality of out-of-hospital care are evaluated. This includes the time from the arrival of emergency services to hospitalization, the amount of sedative and vasopressor drugs used, and the mortality rate during this period.

  7. Step 7

    Follow-up and mortality assessment

    The follow-up period extends to 28 days post-intubation. Mortality is assessed using the French Register of deceased persons to determine the vital status of patients after hospital admission.

Who can join the trial?

6 criteria

  • The patient must be an adult, which means they are 18 years old or older.
  • The patient must be experiencing vital distress, which is a serious condition where the body is struggling to function properly, and they need an emergency procedure called endotracheal intubation. This is when a tube is placed into the windpipe to help with breathing.
  • The patient must be treated by the participating SMUR, which is a medical emergency service.
  • The patient can have any condition like trauma (injury), dyspnea (difficulty breathing), coma (unconsciousness), overdoses, or shock, but they should not be in cardiac arrest, which is when the heart stops beating.
  • Both male and female patients can participate.
  • The study does not include vulnerable populations, which means groups of people who might need special protection or care.

Who cannot join the trial?

2 criteria

  • Patients who are not adults. This means anyone under the age of 18 cannot participate.
  • Patients who are part of a vulnerable population. This refers to groups of people who might need special protection or care, such as those with certain disabilities or conditions.
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Investigated drugs

  • Rocuronium

    is a medication used to relax the muscles during surgery or other medical procedures. In this trial, it is used to help with tracheal intubation, which is the process of inserting a tube into the windpipe to help a patient breathe. Rocuronium helps by relaxing the muscles around the windpipe, making it easier to insert the tube.

  • Bag Face-Mask Ventilation

    is a technique used to help patients breathe before intubation. It involves using a mask that fits over the patient's nose and mouth, connected to a bag that can be squeezed to push air into the lungs. This helps ensure the patient gets enough oxygen before the intubation procedure.

  • GEB (Gum Elastic Bougie)

    is a flexible tool used to assist with tracheal intubation. It is inserted into the windpipe to guide the placement of the intubation tube. The GEB helps ensure that the tube is correctly positioned, which is important for the patient's safety and effective breathing support.

What is already known about the treatment

Rocuronium – Rocuronium is administered intravenously and is used as a muscle relaxant during tracheal intubation procedures. It is currently being studied in clinical trials to assess its effectiveness in reducing complications following emergency tracheal intubation. The main therapeutic indication for rocuronium is to facilitate tracheal intubation and provide muscle relaxation during surgery or mechanical ventilation. At the molecular level, rocuronium works by blocking the action of acetylcholine at neuromuscular junctions, preventing muscle contraction. It is classified as a non-depolarizing neuromuscular blocking agent.

Investigated diseases

Respiratory Distress – Respiratory distress is a condition where an individual experiences difficulty in breathing, often characterized by rapid, shallow breathing and a feeling of not getting enough air. It can occur due to various reasons, including lung infections, asthma, or chronic obstructive pulmonary disease (COPD). The condition may lead to increased heart rate, sweating, and a bluish tint to the skin due to lack of oxygen. As it progresses, the person may struggle more to breathe, and the chest may move inwards with each breath. In severe cases, respiratory distress can lead to exhaustion and confusion due to insufficient oxygen reaching the brain. It requires immediate medical attention to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514913-37-00Protocol codeCHUBX 2021/25Estimated enrolment1 500 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

sourced from the EU Clinical Trials Register and site verification

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