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

Poitiers University Hospital

Status: Completed

Conditions: General Anesthesia

Treatments: Device: Isometric Trumb Force handle

Study type: Interventional

Funder types: Other

Identifiers

NCT03847740

MONITOF

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Right Isometric Thumb Force (ITF) handle

Experimental group

Treatment:

Device: Isometric Trumb Force handle

Left Isometric Thumb Force (ITF) handle

Experimental group

Treatment:

Device: Isometric Trumb Force handle