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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03847740
Other study ID # MONITOF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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