Cardiac Output and Recovery Time

NCT04619225 | Terminated Results FDA Device

• 1 other identifier: 20-001771
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Residual Neuromuscular Blockade

Keywords

Neuromuscular Blockade; Tetragraph; AMG; EMG

Outcome Measures

Primary Outcomes (1)

• Recovery Time After Administration of Sugammadex and Its Correlation to Cardiac Output Measure

  The correlation between the mean change in cardiac output measurement after reversal with sugammadex to the time it takes to recover from the rocuronium-induced blockade. The Pearson's correlation method was used to calculate the correlation coefficient.

  Up to 1 hour postoperative

Secondary Outcomes (1)

• Correlation of Speed of Recovery From Neuromuscular Blockade and Age.

  Up to 1 hour postoperative

Study Arms (1)

TetraGraph monitoring

EXPERIMENTAL

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

Device: TetraGraph

Interventions

TetraGraph DEVICE

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.

TetraGraph monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32223, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was terminated early due to a lack of interest.

Results Point of Contact

• Title: J. Ross Renew, M.D.
• Organization: Mayo Clinic

renew.j@mayo.edu

904-956-3328

Study Officials

• J.Ross Renew, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: September 14, 2022
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)