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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04619225
Other study ID # 20-001771
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 14, 2022
Est. completion date December 2024

Study information

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

Clinical Trial Summary

The purpose of this research is to determine the time it takes to reverse the effects of the intraoperative medication given to relax the muscles and how this period of recovery correlates with a function of the heart.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > or = 18 years old. - Patients willing to participate and provide an informed consent. - Patients undergoing an elective surgical procedure requiring administration of rocuronium, and the use of a pulmonary artery catheter intraoperatively. Exclusion Criteria: - Patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture. - 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 or leg into the sterile field.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
TetraGraph
FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.

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 Recovery time after administration of sugammadex and its correlation to cardiac output measure Change in cardiac output measurement after reversal with sugammadex as compared to the time it takes to recover from the rocuronium-induced blockade. Up to 1 hour postoperative
Secondary Correlation of speed of recovery from neuromuscular blockade and age. Change in the speed of recovery from neuromuscular blockade as compared to participant's age. Up to 1 hour postoperative
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