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Neuromuscular Blocking Agent

Rocuronium vs Succinylcholine for Anesthesia

Phase 4

Recruiting

Led By Lauren M Nakazawa, MD,MBA

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BMI > 30kg/m2 or Mallampati class III or IV

Requiring general anesthesia and endotracheal intubation

Must not have

Patients with suspected or diagnosed neuromuscular disease, patients with burn injuries

Untreated ischemic heart disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 hours after surgery

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare two drugs for tracheal intubation to assess intubation conditions, efficiency, success rate, patient awareness, and post-op paralysis.

Who is the study for?

This trial is for adults needing general anesthesia and intubation, with a BMI over 30 or a Mallampati score of III/IV. It's not for those allergic to certain anesthetics, pregnant women, people with severe health issues (ASA > III), renal failure with high potassium levels, respiratory disorders like COPD/asthma, untreated heart disease, history of malignant hyperthermia or neuromuscular diseases.

What is being tested?

The study compares two drugs used during rapid anesthesia induction: rocuronium (0.6 mg/kg) and succinylcholine (1 mg/kg). It looks at how well they work for putting in a breathing tube by checking ease of laryngoscopy, vocal cord view/opening, limb movement and coughing during the procedure.

What are the potential side effects?

Possible side effects include allergic reactions to the drugs used; muscle pain from succinylcholine; changes in heart rate or blood pressure; nausea or vomiting post-operation. Rocuronium may require reversal agents if it lasts too long.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is over 30, or I have a high Mallampati score.

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I will need general anesthesia and a breathing tube for my procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a neuromuscular disease or have suffered from burn injuries.

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I have heart disease that hasn't been treated.

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I have kidney issues and my potassium level is unknown or above 5.0.

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I or someone in my family has had malignant hyperthermia.

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I have a lung condition like asthma or COPD.

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I need to be awake during my intubation procedure.

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I need less than 1 mg/kg of propofol for initial sedation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 hours after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 24 hours after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 hours after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ease of laryngoscopy

Movement of vocal cords

Number of participants who moved their limbs during intubation

+2 more

Secondary study objectives

Airway view at the time of laryngoscopy as categorized by the modified Cormack-Lehane classification (before external manipulation)

Number of participants that had injury associated with intubation

Number of participants who had presence of sore throat as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction

+2 more