Cardiac Output and Recovery Time

Not Applicable

• Conditions: Residual Neuromuscular Blockade
• Interventions: Device: TetraGraph

• Registration Number: NCT04619225
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-06
• Study Start: 2022-09-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TetraGraph monitoring	TetraGraph	Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on either hand at a discretion of the anesthesiologist

Primary Outcome Measures

Name	Time	Method
Recovery time after administration of sugammadex and its correlation to cardiac output measure	Up to 1 hour postoperative	Change in cardiac output measurement after reversal with sugammadex as compared to the time it takes to recover from the rocuronium-induced blockade.

Secondary Outcome Measures

Name	Time	Method
Correlation of speed of recovery from neuromuscular blockade and age.	Up to 1 hour postoperative	Change in the speed of recovery from neuromuscular blockade as compared to participant's age.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States