Train-of-four Monitoring Using the Tetragraph

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Device: Tetragraph (TM) NMT Monitor

• Registration Number: NCT04475250
• Lead Sponsor: Joseph D. Tobias

Brief Summary

This is a prospective study that will evaluate the feasibility of using the Tetragraph Neuromuscular Transmission Monitor in comparison to standard (visual) train-of-four assessment with a peripheral nerve stimulator in pediatric patients undergoing surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-17
• Study Start: 2021-02-01
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30
• Results First Submitted: 2024-06-21
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Results First Posted: 2024-08-12
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

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

Inclusion Criteria

• Pediatric patients requiring anesthetic care and use of neuromuscular blockade
• Weight range of 20 - 60 kg

Exclusion Criteria

• Patients with history of a peripheral neurologic or neuropathic disorder
• Patients in whom the upper extremity cannot be used for TOF monitoring
• Patients undergoing a surgical procedure in which neuromuscular blockade is not required
• Edematous patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tetragraph	Tetragraph (TM) NMT Monitor	-

Primary Outcome Measures

Name	Time	Method
Recovered TOFr (%)	At the end of surgery (maximum 7 hours from baseline)	Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Recovered TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) after recovery from the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A TOFr greater than or equal to 90% indicates adequate recovery from the neuromuscular block.
Baseline TOFr (%)	Immediately prior to start of surgery	Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Baseline TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) prior to administration of the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A lower TOFr equals stronger neuromuscular block and more muscle paralysis.

Secondary Outcome Measures

Name	Time	Method
Recovered Amplitude (mV)	At the end of surgery (maximum 7 hours from baseline)	The amplitude of the muscle action potential after recovery from the neuromuscular blocking agent.
Rate of Muscle Recovery (Minutes)	At the end of surgery (maximum 7 hours from baseline)	The amount of time it took to return to a TOFr \>90% following reversal of neuromuscular blocking agent.
Baseline Amplitude (mV)	Immediately prior to start of surgery	The amplitude of the muscle action potential prior to administration of the neuromuscular blocking agent.

Trial Locations

Locations (1)

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