Comparison of remifentanil and rocuronium for improving video laryngoscopy assisted tracheal intubation in adult patients undergoing general anesthesia

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What is this study about?

This clinical study compares two medications used during general anesthesia when placing a breathing tube into the windpipe using a special camera device called video laryngoscopy. The two medications being studied are remifentanil, a strong pain medication, and rocuronium, a muscle relaxant. Both medications are given through a vein as an injection.

The purpose of this research is to determine which medication provides better and safer conditions for placing the breathing tube in adult patients who need tracheal intubation during surgery. The study will look at how well each medication works and any possible side effects that may occur during or after the procedure.

During the study, patients will receive either remifentanil or rocuronium before the breathing tube is inserted. Doctors will monitor patients for any complications that might occur within 24 hours after the procedure, including effects on breathing, heart function, or discomfort in the throat. The medication doses are carefully calculated based on each patient’s weight, with remifentanil given at up to 4 micrograms per kilogram and rocuronium at up to 0.6 milligrams per kilogram.

1 Initial assessment and preparation

Your eligibility for the study will be confirmed based on the following criteria: you must be at least 18 years old, scheduled for general anesthesia requiring a breathing tube, and have an ASA physical status score between I and III (indicating your overall health condition).

The procedure will be performed using a special camera device called a video laryngoscope to help place the breathing tube.

2 Medication assignment

You will be randomly assigned to receive one of two medications through an intravenous injection:

Option 1: Remifentanil (a pain medication)

Option 2: Rocuronium (a muscle relaxant)

3 Anesthesia procedure

The assigned medication will be administered through an intravenous line (a small tube in your vein)

A breathing tube will be placed using the video laryngoscope

Your vital signs and condition will be continuously monitored during the procedure

4 Monitoring period

You will be monitored for any immediate effects during the first 20 minutes after the procedure

Continued observation will occur for up to 24 hours after the procedure to check for any delayed effects

5 Assessment of outcomes

The medical team will evaluate the success of the tube placement on the first attempt

Any effects you experience will be documented, including throat discomfort, breathing changes, or other reactions

Your participation in the study will end after the 24-hour monitoring period

Who Can Join the Study?

  • Must be at least 18 years old
  • Must be scheduled for general anesthesia that requires placement of a breathing tube through the mouth into the windpipe
  • Must not require rapid sequence induction (a special fast technique for placing breathing tubes in emergency situations)
  • Must have an ASA physical status score between I and III (this is a scale used by anesthesiologists to assess a patient’s overall health before surgery: I means healthy, II means mild systemic disease, III means severe systemic disease)
  • Can be either male or female
  • Must be having a procedure where a video laryngoscope (a device with a camera used to help place breathing tubes) will be used

Who Cannot Join the Study?

  • Known allergy or hypersensitivity (severe adverse reaction) to remifentanil, rocuronium, or similar medications
  • Pregnant or breastfeeding women
  • Patients with severe liver disease (conditions affecting liver function)
  • Patients with severe kidney disease (conditions affecting kidney function)
  • History of difficult airway (previous problems with breathing tube placement)
  • Patients with neuromuscular disorders (conditions affecting muscle and nerve function)
  • Emergency or urgent surgeries requiring immediate intubation
  • Patients taking medications that could interact with study drugs
  • Participation in another clinical trial within the past 30 days
  • Inability to provide informed consent
  • Patients under 18 years of age
  • Patients with severe cardiovascular disease (heart and blood vessel conditions)
  • Known or suspected drug abuse
  • Patients with increased pressure inside the skull
  • Patients with severe breathing problems

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Lillebaelt Hospital Kolding Denmark
Aalborg University Hospital Aalborg Denmark
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Sygehus Soenderjylland Soenderborg Aabenraa Denmark
Region Sjaelland Holbæk Denmark
Helhqa Hbhgueje Herlev Denmark
Rizlpx Swybzikwlq Vejle Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.09.2025

Trial locations

Remifentanil is a fast-acting opioid pain medication used during surgery. It helps to reduce pain and make intubation (inserting a breathing tube) more comfortable for patients during general anesthesia. The medication’s effects wear off quickly after stopping its administration.

Rocuronium is a muscle relaxant medication used during surgery to temporarily paralyze the muscles. It helps doctors insert breathing tubes more easily by relaxing the muscles in the throat and airways. The medication’s effects can be reversed when needed using specific antidote medications.

Both medications are being compared in this trial to determine which one provides better conditions for inserting breathing tubes using a video laryngoscope (a device with a camera used to guide tube placement) during general anesthesia.

Investigated diseases:

Respiratory Failure – A condition where the respiratory system fails in one or both of its gas exchange functions: oxygenation and carbon dioxide elimination. The condition can develop gradually or suddenly, making it difficult for a person to breathe normally. It occurs when the lungs cannot get enough oxygen into the blood or remove enough carbon dioxide from it. The condition can be acute (developing quickly) or chronic (developing over time).

Airway Trauma – An injury to the throat, windpipe, or breathing passages that can occur during medical procedures or accidents. It can affect any part of the upper or lower airway system. The condition can cause breathing difficulties and discomfort. Symptoms may include voice changes, difficulty swallowing, or breathing problems.

Pulmonary Aspiration – A condition where food, drink, or stomach contents enter the airways instead of going into the esophagus and stomach. This occurs when the normal protective mechanisms of the body fail. The condition can cause inflammation in the lungs and breathing difficulties. It commonly occurs when someone is unconscious or has impaired reflexes.

Bradycardia – A heart condition where the heart beats slower than normal, typically fewer than 60 beats per minute. The slow heart rate may cause insufficient blood flow to the body. Some people with bradycardia may experience fatigue, dizziness, or shortness of breath. The condition can range from mild to severe.

Pneumonia – An infection that inflames the air sacs in one or both lungs. The air sacs may fill with fluid or pus, causing cough, fever, and difficulty breathing. The infection can be caused by various germs, including bacteria, viruses, and fungi. The severity can range from mild to severe.

Trial ID:
2025-521405-40-01
NCT ID:
NCT06564857
Trial Phase:
Human Pharmacology (Phase I) – Other

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