Safety and Feasibility of a New Neuromuscular Monitoring Device

Not Applicable

Completed

• Conditions: General Anesthesia
• Interventions: Device: Isometric Trumb Force handle

• Registration Number: NCT03847740
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-20
• Study Start: 2019-02-22
• Primary Completion: 2019-08-22
• Study Completion: 2019-08-22
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Right Isometric Thumb Force (ITF) handle	Isometric Trumb Force handle	-
Left Isometric Thumb Force (ITF) handle	Isometric Trumb Force handle	-

Primary Outcome Measures

Name	Time	Method
Delay of block installation between the injection and the disappearance of all the muscular contractions to stimulation by train of four	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 Outcome Measures

Name	Time	Method
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.	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
Clinical examination	the first 24 postoperative hours	Wrist pain
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.	Delay of the gear ratio from train of four to 25; 75 and 90%.
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.	The response of theses tetanus stimulations will be compared with the one observed before myorelaxant administration but after induction of anesthesia

Trial Locations

Locations (1)

Chu de Poitiers; 🇫🇷 Poitiers, France