Cardiac Output and Recovery Time

Residual Neuromuscular Blockade Clinical Trial

Official title:

Correlation Between Cardiac Output and Recovery Time After Reversal of Rocuronium-Induced Blockade With Sugammadex

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04619225
• Other study ID #: 20-001771
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Residual Neuromuscular Blockade

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

External Links

•   Mayo Clinic Clinical Trials