Intubating Conditions of Neuromuscular Blockade

Study Overview
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Brief Summary
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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.

Official Title
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Intubating Conditions at Various Levels of Neuromuscular Blockade

Conditions
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Endotracheal Intubation

Intervention / Treatment
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* Procedure: Endotracheal Intubation at TOFC=1
* Procedure: Endotracheal Intubation 2 minutes after rocuronium administration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intubation at TOFC=1<br>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) | Procedure: Endotracheal Intubation at TOFC=1<br>* Intubation using a video laryngoscopy will be performed after train-of-four (TOFC) stimulation indicates neuromuscular blockade<br>|
| Active Comparator: Intubation 2 minutes after rocuronium administration<br>Subjects scheduled for an elective surgical procedure will have endotracheal intubation performed 2 minutes after the anesthesia provider gives muscle relaxing medication | Procedure: Endotracheal Intubation 2 minutes after rocuronium administration<br>* Intubation using a video laryngoscopy will be performed 2 minutes after administration of rocuronium at 0.6 mg/kg (usual current clinical routine)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the intubating conditions | Evaluated by the healthcare providers using a scale that includes 4 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 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. | Approximately 15 minutes after intubation |