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Clinical Trials/NCT06472284
NCT06472284
Active, not recruiting
Not Applicable

Train-of-four Monitoring Using the TetraGraph Neuromuscular Transmission Monitor to Evaluate Rocuronium Infusion Requirements During Major Neurosurgical and Surgical Procedures

Joseph D. Tobias1 site in 1 country50 target enrollmentSeptember 12, 2024
ConditionsSurgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Joseph D. Tobias
Enrollment
50
Locations
1
Primary Endpoint
EMG changes
Status
Active, not recruiting
Last Updated
6 months ago

Overview

Brief Summary

This is a prospective, non-blinded study to evaluate rocuronium infusion requirements using the TetraGraph Neuromuscular Transmission Monitor during surgical procedures in patients less than 18 yrs. of age.

Registry
clinicaltrials.gov
Start Date
September 12, 2024
End Date
December 1, 2025
Last Updated
6 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Joseph D. Tobias
Responsible Party
Sponsor Investigator
Principal Investigator

Joseph D. Tobias

Chief, Dept. of Anesthesiology & Pain Medicine

Nationwide Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients less than 18 years of age
  • American Society of Anesthesiologists classification (ASA) 1-4
  • Patients undergoing a surgical procedure with general anesthesia and requiring the continuous administration of rocuroniuim

Exclusion Criteria

  • Patients less than 28 days old
  • Patients with history of a progressive or degenerative peripheral neurologic or neuropathic disorder
  • Patients undergoing a surgical procedure in which neuromuscular blockade is not required
  • Edematous patients

Outcomes

Primary Outcomes

EMG changes

Time Frame: During the surgery (2-8 hrs.)

Changes in the amplitude of the evoked response of the muscles

Maximum dose of rocuronium

Time Frame: During the surgery (2-8 hrs.)

The maximum dose of rocuronium administered by a continuous infusion to maintain one twitch of the train of four (TOF)

Study Sites (1)

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