Intubating Conditions at Various Levels of Neuromuscular Blockade
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Number of Subjects With Optimal Intubating Conditions
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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)
Intervention: Endotracheal Intubation at TOFC=1 (Procedure)
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
Intervention: Endotracheal Intubation 2 minutes after rocuronium administration (Procedure)
Outcomes
Primary Outcomes
Number of Subjects With Optimal Intubating Conditions
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
J. Ross Renew, M.D.
Principal Investigator
Mayo Clinic