General Anesthesia
Conditions
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.
Interventions
DEVICEIsometric Trumb Force handle
Compare the pattern of neuromuscular blocking drug between two devices applied on the same patient during general anesthesia.
Sponsors
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical examination | the first 24 postoperative hours | Appearance of the wrist skin (for example: redness, irritations or marks) |
| 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 |
| 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 |
Countries
France
Outcome results
None listed