Safety and Feasibility of a New Neuromuscular Monitoring Device

NCT03847740 | Completed

• 1 other identifier: MONITOF
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Clinical examination

  the first 24 postoperative hours

• Clinical examination

  the first 24 postoperative hours

• Characteristics of maintenance curarization

  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

  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

  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.

Study Arms (2)

Right Isometric Thumb Force (ITF) handle

EXPERIMENTAL

Device: Isometric Trumb Force handle

Left Isometric Thumb Force (ITF) handle

EXPERIMENTAL

Device: Isometric Trumb Force handle

Interventions

Isometric Trumb Force handle DEVICE

Compare the pattern of neuromuscular blocking drug between two devices applied on the same patient during general anesthesia.

Left Isometric Thumb Force (ITF) handle; Right Isometric Thumb Force (ITF) handle

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Chu de Poitiers

Poitiers, 86021, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: February 20, 2019
• Study Start: February 22, 2019
• Primary Completion: August 22, 2019
• Study Completion: August 22, 2019
• Last Updated: October 31, 2019

Record last verified: 2019-10

Locations

FR (1)