Safety and Feasibility of a New Neuromuscular Monitoring Device
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- General Anesthesia
- Sponsor
- Poitiers University Hospital
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Delay of block installation between the injection and the disappearance of all the muscular contractions to stimulation by train of four
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Delay of block installation between the injection and the disappearance of all the muscular contractions to stimulation by train of four
Time Frame: 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 Outcomes
- 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.)
- Clinical examination(the first 24 postoperative hours)
- 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.)
- 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.)