152 Participants Needed

Rocuronium vs Succinylcholine for Anesthesia

LM
ET
Overseen ByEllie Tuchaai
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two drugs, rocuronium and succinylcholine, to determine which works better for patients requiring general anesthesia and a breathing tube during surgery. Researchers aim to assess the ease of performing the procedure with each drug and whether patients recall any part of it afterward. Suitable candidates for this trial include those needing surgery, with a BMI over 30, or a challenging airway classification (Mallampati class III or IV). As a Phase 4 trial, this study involves FDA-approved treatments and seeks to understand how they can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research shows that both rocuronium and succinylcholine are generally safe for people, but they have some differences. Rocuronium, a muscle relaxant often used during surgeries, helps relax muscles and facilitates the insertion of a breathing tube. Studies suggest rocuronium can increase heart rate, though this isn't always noticeable. Some reports also indicate it can help reduce stress during surgery.

Succinylcholine, another muscle relaxant, is used for quick procedures. Known for its rapid action, it is often employed in emergencies. However, some individuals might experience muscle pain or rare issues like changes in heart rhythm.

Overall, both treatments are widely used and usually well-tolerated when used correctly. For those considering joining a trial, these findings suggest the treatments are generally safe, but discussing any concerns with the study team is important.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they explore different approaches to rapid sequence induction (RSI) for anesthesia. Rocuronium, used in the Modified Time Principle Induction (MTPI) method, offers a potentially smoother and longer-lasting muscle relaxation compared to succinylcholine, which is typically used for its fast-acting properties. Unlike succinylcholine, which can cause certain side effects like increased potassium levels, rocuronium provides an alternative for patients where these risks are a concern. This study aims to determine if MTPI with rocuronium can be as effective or superior to the traditional use of succinylcholine, potentially offering a safer or more efficient option for anesthesia induction.

What evidence suggests that this trial's treatments could be effective for anesthesia?

This trial will compare the effectiveness of rocuronium and succinylcholine for tracheal intubation. Research has shown that both drugs effectively aid in breathing tube placement. Participants may receive rocuronium, which studies have found to work well, especially in children, by providing good conditions for tube insertion and high success rates on the first attempt. Rocuronium relaxes muscles by blocking nerve signals. Alternatively, participants may receive succinylcholine, which acts quickly and has been the standard choice for rapid intubation. Evidence indicates that while recovery from rocuronium may take slightly longer, it remains a reliable alternative to succinylcholine. Both drugs have proven effective for intubation procedures.26789

Who Is on the Research Team?

LM

Lauren M Nakazawa, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My BMI is over 30, or I have a high Mallampati score.
I will need general anesthesia and a breathing tube for my procedure.

Exclusion Criteria

The American Society of Anesthesiologists (ASA) physical status classification > III
Pregnant women
I have a neuromuscular disease or have suffered from burn injuries.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Induction and Intubation

Participants undergo rapid sequence induction and tracheal intubation using either rocuronium or succinylcholine. Conditions such as ease of laryngoscopy, vocal cord view, and movement during intubation are assessed.

Less than 7 minutes
1 visit (in-person)

Post-operative Monitoring

Participants are monitored for post-operative recall of paralysis, injury associated with intubation, and overall satisfaction within 24 hours after surgery.

24 hours
1 visit (in-person)

Follow-up

Participants are monitored for any delayed adverse effects and overall satisfaction with the procedure.

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Rocuronium
  • Succinylcholine
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Modified Time Principle Induction (MTPI) with rocuroniumExperimental Treatment1 Intervention
Group II: RSI with succinylcholineActive Control1 Intervention

Rocuronium is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Zemuron for:
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Approved in European Union as Esmeron for:
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Approved in Canada as Esmeron for:
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Approved in Japan as Esmeron for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Published Research Related to This Trial

In a study involving 240 women undergoing cesarean delivery, rocuronium with sugammadex was found to be noninferior to succinylcholine in terms of time to tracheal intubation, with only a 2.9-second longer average time.
Rocuronium also resulted in fewer complications, such as postpartum myalgia and subjective complaints, compared to succinylcholine, indicating it may be a safer alternative for rapid-sequence induction in this setting.
Low-Dose or High-Dose Rocuronium Reversed with Neostigmine or Sugammadex for Cesarean Delivery Anesthesia: A Randomized Controlled Noninferiority Trial of Time to Tracheal Intubation and Extubation.Stourac, P., Adamus, M., Seidlova, D., et al.[2018]
Succinylcholine is the only neuromuscular blocking agent with a rapid onset and ultra-short duration, but it carries significant risks, including potentially fatal side effects, making it a controversial choice for rapid sequence intubation (RSI) in children.
Rocuronium is preferred by many emergency physicians for RSI in children due to its excellent safety profile and rapid onset, despite having a longer duration of action compared to succinylcholine.
Emergency department use of neuromuscular blocking agents in children.Doobinin, KA., Nakagawa, TA.[2019]
In a study of 233 patients with traumatic brain injury who underwent rapid sequence intubation, succinylcholine was associated with a significantly higher mortality rate in patients with severe injuries compared to rocuronium, with an odds ratio of 4.10.
For patients with less severe injuries, there was no significant difference in mortality between those treated with succinylcholine and those treated with rocuronium, indicating that the choice of neuromuscular blocker may be critical in high-severity cases.
Succinylcholine Is Associated with Increased Mortality When Used for Rapid Sequence Intubation of Severely Brain Injured Patients in the Emergency Department.Patanwala, AE., Erstad, BL., Roe, DJ., et al.[2018]

Citations

Rocuronium versus succinylcholine for rapid sequence ...Rocuronium has been suggested as an alternative to succinylcholine for intubation. This is an update of our Cochrane review published first in 2003 and then ...
The Effect of Drug Selection on Pediatric Rapid Sequence ...Our systematic review demonstrated that rocuronium provides superior intubating conditions, allowing for improved first-pass success rates in pediatric RSI.
Rocuronium - StatPearls - NCBI Bookshelf - NIHRocuronium is a non-depolarizing neuromuscular blocker widely used to produce muscle relaxation to help facilitate surgery and ventilation of the lungs.
Rapid Sequence Induction With a Standard Intubation ...High-dose rocuronium bromide may be an alternative to succinylcholine for RSI but recovery times are nearly doubled compared with a standard intubating dose of ...
Effect of Rocuronium vs Succinylcholine on Endotracheal ...This noninferiority trial compares the effect of rocuronium vs succinylcholine on first-attempt tracheal intubation success rate in ...
The safety of high-dose rocuronium bromide in general ...Meanwhile, high-dose rocuronium bromide can shorten intubation time, which is conducive to the smooth operation and reduces surgical stress injuries. Keywords: ...
New Practice Guidelines for Neuromuscular BlockadeThe practice guidelines present eight recommendations regarding the type of monitoring of neuromuscular blockade, location of monitoring, and medications used.
rocuronium bromide injection - accessdata.fda.govThe data also suggest that Rocuronium Bromide Injection may increase heart rate. However, it was not possible to conclusively identify an effect of ...
Intubation conditions and neonatal outcomes with rocuronium ...While general anesthesia is necessary for some emergency deliveries, it carries risks such as failed intubation and neonatal complications.
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