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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05120999
Other study ID # 21-007425
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 25, 2021
Est. completion date January 14, 2022

Study information

Verified date August 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this research is to use 2 devices to compare the difference in the amount of time it takes for each device to register complete muscle relaxation after the muscle relaxing medication is given. The comparison will be made by using electromyographic (EMG), such as TetraGraph, and acceloromyographic (AMG), such as TOFScan, monitors at the time of insertion of breathing tube.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 14, 2022
Est. primary completion date January 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Train of four measurement
Use of either TetraGraph or TOFScan to measure the neuromuscular blockade

Locations

Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time difference Compare time difference from neuromuscular blockade agent administration to neuromuscular blockade onset During the initiation of anesthesia period
Secondary Intubating conditions Assess intubating conditions once a complete neuromuscular blockade has been achieved either by TetraGraph or TOFScan measurements During the initiation of anesthesia period
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