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Completed

NCT Number: NCT03847740

Safety and Feasibility of a New Neuromuscular Monitoring Device

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.

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Key information

Conditions

General Anesthesia

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Poitiers

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isometric Trumb Force handle

Device

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

Primary outcomes

  1. Delay of block installation between the injection and the disappearance of all the muscular contractions to stimulation by train of four

    Time frame: 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.

    We compare the response to curare with one side a conventional TOF Watch SX monitor and other side Handle Isometric Thumb Force.

Secondary outcomes

  1. Clinical examination

    Time frame: the first 24 postoperative hours

    Appearance of the wrist skin (for example: redness, irritations or marks)

  2. Clinical examination

    Time frame: the first 24 postoperative hours

    Wrist pain

  3. Characteristics of maintenance curarization

    Time frame: 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.

    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

  4. Characteristics of decurarization during spontaneous recovery phase

    Time frame: 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.

    Delay of the gear ratio from train of four to 25; 75 and 90%.

  5. 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

    Time frame: 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.

    The response of theses tetanus stimulations will be compared with the one observed before myorelaxant administration but after induction of anesthesia

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: MONITOF

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 20, 2019
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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