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

170 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to learn about the difference in the endotracheal intubation condition (ease of using a device to view vocal cords, position of vocal cords, and patient's reaction to endotracheal tube insertion) and determining the appropriate time to perform the intubation.

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 data supports the effectiveness of the drug Rocuronium for endotracheal intubation?

Research shows that Rocuronium provides good to excellent conditions for intubation within 45 to 60 seconds after anesthesia induction, making it a useful option for endotracheal intubation. It is faster than other muscle relaxants like vecuronium and atracurium, and while not as fast as succinylcholine, it is a suitable alternative when succinylcholine cannot be used. ^{1 2 3 4 5}

Is rocuronium safe for use in humans?

Rocuronium is generally considered safe for use in humans as it is a muscle relaxant that does not release histamine, which can cause allergic reactions. It is used to facilitate endotracheal intubation (inserting a tube into the windpipe) and has been studied for its effects on muscle relaxation and timing for safe intubation. ^{5 6 7 8 9}

How does the drug rocuronium differ from other drugs for endotracheal intubation?

Rocuronium, when used with the 'timing principle', provides good to excellent intubating conditions quickly, within 45 to 60 seconds after anesthesia induction, making it a fast-acting alternative to succinylcholine, especially when the latter is not suitable. Unlike succinylcholine, rocuronium is a nondepolarizing muscle relaxant, which means it works differently by blocking nerve signals to muscles without causing initial muscle contractions. ^{1 2 5 10 11}

Research Team

J. Ross Renew, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Tracheal intubation with rocuronium using the "timing principle". [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

[Mechanomyographic and electromyographic studies of endotracheal intubation with 2 different rocuronium dosages]. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Rocuronium--onset times and intubating conditions. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Intubating conditions and onset of action after rocuronium, vecuronium, and atracurium in young children. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Pharmacological interventions for acceleration of the onset time of rocuronium: a meta-analysis. [2018]

6. Japan pubmed.ncbi.nlm.nih.gov

A randomized trial to identify optimal precurarizing dose of rocuronium to avoid precurarization-induced neuromuscular block. [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

High-dose rocuronium-induced paralysis of the adductor pollicis muscle facilitates detection of the timing for tracheal intubation in elderly patients: a randomized double-blind study. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

[Optimum intubating dose of rocuronium for short duration surgery in adult patients]. [2018]

9. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Comparison of neuromuscular action of rocuronium, a new steroidal non-depolarizing agent, with vecuronium. [2018]

10. England pubmed.ncbi.nlm.nih.gov

BET 2: Is the use of long-acting neuromuscular blocking agents for intubation associated with reduced provision of postintubation sedation? [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

[Rocuronium or vecuronium for intubation for short operations in the preschool age? Effects on time in the operating room and postoperative phase]. [2018]