Timed Intubation after Rocuronium for Endotracheal Intubation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: NMBA agents

Disqualifiers: Stroke, Myasthenia gravis, Severe renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best timing for endotracheal intubation, which involves placing a tube in the windpipe to assist breathing during surgery. Researchers are comparing two methods: intubating when muscle relaxation shows a single twitch and intubating two minutes after administering the muscle relaxant rocuronium (also known as Zemuron or Esmeron). Individuals undergoing planned surgeries who require muscle relaxants may be suitable candidates. However, those with certain nerve conditions or serious organ issues should not participate. As an unphased trial, this study provides an opportunity to help optimize surgical procedures for improved patient outcomes.

Will I have to stop taking my current medications?

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

What prior data suggests that this intubation technique is safe?

Research has shown that rocuronium, a muscle relaxant used in surgeries, can cause side effects during procedures involving breathing tube insertion. One study found that 9% of patients experienced low blood oxygen levels, and 6.4% had low blood pressure when rocuronium was used. Despite these side effects, the medication remains widely used and is generally considered effective, with a high success rate for first attempts at inserting the breathing tube. Prospective trial participants should consider these potential risks when evaluating involvement in a trial involving rocuronium. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different timings for performing endotracheal intubation after administering rocuronium, a muscle relaxant. Traditionally, intubation is done based on a set time after administering the medication, but this trial compares that to waiting until a specific level of muscle relaxation is detected. This approach could lead to more precise timing for intubation, potentially improving patient safety and comfort during surgical procedures. By exploring these methods, researchers hope to determine the most effective timing for intubation, which could enhance surgical outcomes and minimize complications.

What evidence suggests that this intubation protocol is effective for endotracheal intubation?

This trial will compare two approaches to endotracheal intubation using rocuronium. Research has shown that rocuronium effectively aids doctors in placing a breathing tube in the windpipe. In one study, 81% of patients who received rocuronium had the tube successfully placed on the first try. Another study compared rocuronium to succinylcholine, another muscle relaxant, and found both had similar success rates. Higher doses of rocuronium have proven more effective than lower doses, making the process faster and safer. Overall, rocuronium is a reliable choice for placing a breathing tube smoothly and efficiently. Participants in this trial will undergo intubation either when muscles are almost relaxed, indicated by a single count of muscle twitch, or 2 minutes after rocuronium administration. ^{2 3 5 6 7}

Who Is on the Research Team?

J. Ross Renew, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients needing elective surgery where muscle relaxants like rocuronium are used. Participants must be willing to give informed consent. It's not for those with severe kidney or liver disease, surgeries involving the arm in a sterile field, rapid sequence induction cases, wrist injuries, or neuromuscular conditions like myasthenia gravis.

Inclusion Criteria

I am willing to join the study and can sign the consent form.

I am scheduled for surgery that will use muscle relaxants.

Exclusion Criteria

I have had a stroke, carpal tunnel, broken wrist with nerve damage, Dupuytren contracture, or a similar wrist injury.

My upcoming surgery requires sterilizing my arm.

Patients with systemic neuromuscular diseases such as myasthenia gravis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo endotracheal intubation under different neuromuscular blockade conditions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intubation

15 minutes

What Are the Treatments Tested in This Trial?

Interventions

• Endotracheal Intubation
• Rocuronium

Trial Overview The study is testing two different timings for endotracheal intubation after giving rocuronium: one at 2 minutes post-administration and another when only one twitch (TOFC=1) is observed. The goal is to find out which timing offers better conditions for inserting the breathing tube.

How Is the Trial Designed?

Group I: Intubation at TOFC=1 Experimental Treatment 1 Intervention

Subjects scheduled for an elective surgical procedure will have endotracheal intubation performed when muscles are almost relaxed and monitoring shows only a single count of muscle twitch (in response to a monitor that assesses muscle relaxation)

Group II: Intubation 2 minutes after rocuronium administration Active Control 1 Intervention

Subjects scheduled for an elective surgical procedure will have endotracheal intubation performed 2 minutes after the anesthesia provider gives muscle relaxing medication

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6990819/

Effect of Rocuronium vs Succinylcholine on Endotracheal ... The number of patients with successful first-attempt intubation was 455 of 610 (74.6%) in the rocuronium group vs 489 of 616 (79.4%) in the succinylcholine ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0196064424009624

Association Between Neuromuscular Blocking Agents and ... Successful intubation on the first attempt occurred in 375 patients (78.9%) who received succinylcholine and 1,510 patients (81.0%) who received rocuronium (an ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5062231/

A randomized, double-blind study to compare two doses of ... Conclusions: Rocuronium bromide 0.9 mg/kg is a safer alternative to rocuronium bromide 0.6 mg/kg for endotracheal intubation with shorter time of onset and ...

4. signavitae.com signavitae.com/articles/10.22514/sv.2020.16.0011

Impact of Different Stimulation Patterns of Neuromuscular ... The aim of this study as to evaluate whether different stimulation patterns of neuromuscular blockade monitoring techniques may impact hemodynamic response.

5. journals.lww.com journals.lww.com/md-journal/fulltext/2018/06010/the_effect_of_low_dose_rocuronium_on_rapid.52.aspx

The effect of low-dose rocuronium on rapid tracheal... Low-dose rocuronium provided significantly worse overall intubation conditions compared to the conventional dose of rocuronium for rapid tracheal intubation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12490032/

Intubation conditions and neonatal outcomes with rocuronium ... Multiple trials comparing the safety and efficacy of both agents have reported conflicting outcomes. Some studies reported ROC as non-inferior ...

7. digitalscholar.lsuhsc.edu digitalscholar.lsuhsc.edu/cgi/viewcontent.cgi?article=3993&context=som_facpubs

Association Between Neuromuscular Blocking Agents and ... Patients in the trial data sets who received both succinylcholine and rocuronium were excluded. Measurements and Outcomes. The primary outcome ...