Intubating Conditions of Neuromuscular Blockade

Intubating Conditions at Various Levels of Neuromuscular Blockade

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.

Study Overview

• Status: Completed
• Conditions: Endotracheal Intubation
• Intervention / Treatment: Procedure: Endotracheal Intubation at TOFC=1; Procedure: Endotracheal Intubation 2 minutes after rocuronium administration

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32223
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Optimal Intubating Conditions	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.	Approximately 15 minutes after intubation

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: J. Ross Renew, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Actual): November 6, 2024
• Study Completion (Actual): November 6, 2024

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Therapeutics; Airway Management; Intubation; Intubation, Intratracheal
• Other Study ID Numbers: 22-009153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No