Intubating Conditions of Neuromuscular Blockade

NCT05620108 — Not applicable, Completed, 170 participants, Mayo Clinic

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Intubating Conditions at Various Levels of Neuromuscular Blockade

Registry	NCT05620108
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	170 (Actual)
Sponsor	Mayo Clinic (Other)
Conditions	Endotracheal Intubation
Interventions	Endotracheal Intubation at TOFC=1, Endotracheal Intubation 2 minutes after rocuronium administration (Procedure)
Dates	start 2022-11-28, primary completion 2024-11-06, completion 2024-11-06, first posted 2022-11-17, last updated 2025-10-14
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Intubation at TOFC=1	Experimental	Procedure: Endotracheal Intubation at TOFC=1	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)
Intubation 2 minutes after rocuronium administration	Active comparator	Procedure: Endotracheal Intubation 2 minutes after rocuronium administration	Subjects scheduled for an elective surgical procedure will have endotracheal intubation performed 2 minutes after the anesthesia provider gives muscle relaxing medication

Endotracheal Intubation at TOFC=1 (Procedure): Intubation using a video laryngoscopy will be performed after train-of-four (TOFC) stimulation indicates neuromuscular blockade
Endotracheal Intubation 2 minutes after rocuronium administration (Procedure): Intubation using a video laryngoscopy will be performed 2 minutes after administration of rocuronium at 0.6 mg/kg (usual current clinical routine)

+Outcome measures

Primary outcomes

Number of Subjects With Optimal Intubating Conditions [Approximately 15 minutes after intubation]: The number of subjects who had optimal intubating conditions (total composite score of 3) will be evaluated by the healthcare providers using a scale that includes 3 variables (ease of laryngoscopy, vocal cord position, and reaction to tracheal tube insertion) with 3 response options per each evaluation. The composite score (1-3) will be used, with the lowest total score of 3 correlating with optimal intubating conditions and the highest score of 9 representing the worse possible intubating conditions.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients willing to participate and provide an informed consent.
* Patients undergoing elective surgical procedures that require use of NMBA agents (rocuronium) administered intraoperatively.

Exclusion Criteria:

* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis.
* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents; i.e., severe renal impairment or end-stage liver disease.
* Patients having surgery that would involve prepping the arm into the sterile field.
* Patients receiving a rapid sequence induction.

+Posted results

Participant flow

Milestone	Intubation at TOFC=1	Intubation 2 Minutes After Rocuronium Administration
Started	85	85
Completed	84	83
Not completed	1	2

Outcome results

Number of Subjects With Optimal Intubating Conditions (Primary), Count of participants, Participants: Intubation at TOFC=1 61; Intubation 2 Minutes After Rocuronium Administration 47 (p 0.036)

Adverse events

Time frame: Adverse events were collected from the time of informed consent through study completion, approximately 15 minutes.

Arm	Deaths	Serious adverse events	Other adverse events
Intubation at TOFC=1	0/85 (0.0%)	0/85 (0.0%)	0/85 (0.0%)
Intubation 2 Minutes After Rocuronium Administration	0/85 (0.0%)	0/85 (0.0%)	0/85 (0.0%)

+Locations (1)

Facility	City	Country	Status
Mayo Clinic Florida	Jacksonville, Florida	United States

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2022-11-30)

+Investigators

J. Ross Renew, MD, Principal investigator, Mayo Clinic