TetraGraph in Rocuronium Infusions

Not Applicable

Not yet recruiting

• Conditions: Surgery

• Registration Number: NCT06472284
• Lead Sponsor: Joseph D. Tobias

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25
• Study Start: 2024-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
EMG changes	During the surgery (2-8 hrs.)	Changes in the amplitude of the evoked response of the muscles
Maximum dose of rocuronium	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)

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States