Safety and Feasibility of a New Neuromuscular Monitoring Device

General Anesthesia Clinical Trial

— MONITOF  

Official title:

Safety and Feasibility of a New Neuromuscular Monitoring Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847740
• Other study ID #: MONITOF
• Status: Completed
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: August 22, 2019

Study information

• Verified date: October 2019
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 22, 2019
• Est. primary completion date: August 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Device:
• Isometric Trumb Force handle
Compare the pattern of neuromuscular blocking drug between two devices applied on the same patient during general anesthesia.

Locations

Country	Name	City	State
France	Chu de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical examination	Appearance of the wrist skin (for example: redness, irritations or marks)	the first 24 postoperative hours
Secondary	Clinical examination	Wrist pain	the first 24 postoperative hours
Secondary	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.
Secondary	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.
Secondary	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.