Safety and Feasibility of a New Neuromuscular Monitoring Device (MONITOF)

The aim of the study is to compare, during general anesthesia using neuromuscular blocking agent, the feasibility of a new mechanographic device (ITF handle and Visual ITF software) with a standard acceleromyographic device (TOF Watch SX) and also to assess its safety during the first 24 hours after surgery.

The two devices will be studied simultaneously in each patient.

Study Overview

• Status: Completed
• Conditions: General Anesthesia
• Intervention / Treatment: Device: Isometric Trumb Force handle

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86021
    • CHU De Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients,
• ASA class 1 to 3,
• Scheduled for elective surgery requiring general anesthesia and muscle paralysis

Exclusion Criteria:

• Age inferior to 18 years,
• ASA class 4,
• Emergency surgery,
• Prone position on the operating table

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Right Isometric Thumb Force (ITF) handle	Device: Isometric Trumb Force handle; Compare the pattern of neuromuscular blocking drug between two devices applied on the same patient during general anesthesia.
Experimental: Left Isometric Thumb Force (ITF) handle	Device: Isometric Trumb Force handle; Compare the pattern of neuromuscular blocking drug between two devices applied on the same patient during general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay of block installation between the injection and the disappearance of all the muscular contractions to stimulation by train of four	We compare the response to curare with one side a conventional TOF Watch SX monitor and other side Handle Isometric Thumb Force.	Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical examination	Appearance of the wrist skin (for example: redness, irritations or marks)	the first 24 postoperative hours
Clinical examination	Wrist pain	the first 24 postoperative hours
Characteristics of maintenance curarization	Value of the post-tetanus count at the time of administration of an extra bolus of rocuronium and the number of muscle contractions in response to a four-train stimulation	Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.
Characteristics of decurarization during spontaneous recovery phase	Delay of the gear ratio from train of four to 25; 75 and 90%.	Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.
When the TOF ratio will be greater than 0.9 on the TOF Watch side, the degree of residual paralysis will be assessed on the ITF side using 100 Hz tetanus stimulation repeated 5 times at 2 minutes interval	The response of theses tetanus stimulations will be compared with the one observed before myorelaxant administration but after induction of anesthesia	Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2019
• Primary Completion (Actual): August 22, 2019
• Study Completion (Actual): August 22, 2019

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: MONITOF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No