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Clinical Trials/NCT04475250
NCT04475250
Completed
Not Applicable

Train-of-four Monitoring Using the Tetragraph Neuromuscular Transmission Monitor and Comparison to Standard (Visual) Train-of-four Assessment With a Peripheral Nerve Stimulator

Joseph D. Tobias1 site in 1 country100 target enrollmentFebruary 1, 2021
ConditionsSurgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Joseph D. Tobias
Enrollment
100
Locations
1
Primary Endpoint
Recovered TOFr (%)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
May 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Joseph D. Tobias
Responsible Party
Sponsor Investigator
Principal Investigator

Joseph D. Tobias

Chairman, Dept. of Anesthesiology & Pain Medicine

Nationwide Children's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Recovered TOFr (%)

Time Frame: 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 (%)

Time Frame: 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 Outcomes

  • Recovered Amplitude (mV)(At the end of surgery (maximum 7 hours from baseline))
  • Rate of Muscle Recovery (Minutes)(At the end of surgery (maximum 7 hours from baseline))
  • Baseline Amplitude (mV)(Immediately prior to start of surgery)

Study Sites (1)

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