Intubating Conditions of Neuromuscular Blockade

Mayo Clinic

Status: Completed

Conditions: Endotracheal Intubation

Treatments: Procedure: Endotracheal Intubation 2 minutes after rocuronium administration; Procedure: Endotracheal Intubation at TOFC=1

Study type: Interventional

Funder types: Other

Identifiers

NCT05620108

22-009153

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Intubation at TOFC=1

Experimental group

Description:

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)

Treatment:

Procedure: Endotracheal Intubation at TOFC=1

Intubation 2 minutes after rocuronium administration

Active Comparator group

Description:

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

Treatment:

Procedure: Endotracheal Intubation 2 minutes after rocuronium administration