Intubating Conditions of Neuromuscular Blockade

NCT ID: NCT05620108

Last Updated: 2025-10-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-28

Study Completion Date

2024-11-06

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.

Detailed Description

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Conditions

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Endotracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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)

Group Type EXPERIMENTAL

Endotracheal Intubation at TOFC=1

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Endotracheal Intubation 2 minutes after rocuronium administration

Intervention Type PROCEDURE

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

Intervention Type 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)

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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J. Ross Renew, M.D.

Principal Investigator

Responsibility Role 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

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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22-009153

Identifier Type: -

Identifier Source: org_study_id

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