Intubating Conditions of Neuromuscular Blockade

Not Applicable

• Conditions: Endotracheal Intubation
• Interventions: Procedure: Endotracheal Intubation 2 minutes after rocuronium administration; Procedure: Endotracheal Intubation at TOFC=1

• Registration Number: NCT05620108
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-11-09
• Study First Submitted QC: 2022-11-09
• Study First Posted: 2022-11-17
• Study Start: 2022-11-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 170

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intubation 2 minutes after rocuronium administration	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
Intubation at TOFC=1	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)

Primary Outcome Measures

Name	Time	Method
Assessment of the intubating conditions	Approximately 15 minutes after intubation	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.

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States