Study Results
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View full resultsBasic Information
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COMPLETED
NA
170 participants
INTERVENTIONAL
2022-11-28
2024-11-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
Endotracheal Intubation at TOFC=1
Intubation using a video laryngoscopy will be performed after train-of-four (TOFC) stimulation indicates neuromuscular blockade
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
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)
Interventions
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Endotracheal Intubation at TOFC=1
Intubation using a video laryngoscopy will be performed after train-of-four (TOFC) stimulation indicates neuromuscular blockade
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)
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing elective surgical procedures that require use of NMBA agents (rocuronium) administered intraoperatively.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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J. Ross Renew, M.D.
Principal Investigator
Principal Investigators
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J. Ross Renew, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Florida
Jacksonville, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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22-009153
Identifier Type: -
Identifier Source: org_study_id
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