Comparison of Train of Four, Tetanus 50 and 100 Hz Recovery After Rocuronium Block Reversed by Sugammadex
Primary Purpose
Postoperative Residual Curarization
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TOF SCAN
ITF
Sponsored by
About this trial
This is an interventional other trial for Postoperative Residual Curarization
Eligibility Criteria
Inclusion Criteria:
- ASA clinical status 1 to 3
- Informed consent obtained before anesthesia induction
Exclusion Criteria:
- ASA clinical status 4
- Emergency surgery; scheduled surgery in prone position,
- Hepatic or renal disease,
- BMI higher than 35,
- Allergy to rocuronium or sugammadex
Sites / Locations
- C.H.U. de Poitiers
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TOF scan train of four ratio monitoring
ITF device tetanus stimulation monitoring
Arm Description
Recovery of train of four ratio after sugammadex administration
Recovery of tetanus 100 Hz ratio after sugamamdex administration
Outcomes
Primary Outcome Measures
To compare the recovery of train of four ratio with the tetanus 100 Hz ratio following sugammadex administration to reverse the rocuronium induced neuromuscular bock at the end of the surgical procedure
delay following sugammadex administration to obtain a train of four ratio higher than 0.9 and a tetanus 100 Hz ratio higher than 0.9
Secondary Outcome Measures
Full Information
NCT ID
NCT05003024
First Posted
July 22, 2021
Last Updated
January 3, 2022
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05003024
Brief Title
Comparison of Train of Four, Tetanus 50 and 100 Hz Recovery After Rocuronium Block Reversed by Sugammadex
Official Title
Comparison of Train of Four, Tetanus 50 Hz and Tetanus 100 Hz Recovery Following Rocuronium Induced Neuromuscular Block Reversed by Sugamamdex
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
December 23, 2021 (Actual)
Study Completion Date
December 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Despite neuromuscular transmission monitoring and pharmacological reversal allowing a train of four ratio recovery higher than 0.9, patients receiving neuromuscular blocking agent during general anesthesia have a high risk of postoperative pulmonary complications. While this train of four ratio thershold is considered as the gold standard to confirm the lack of residual paralysis, tetanus 100 Hz stimulation showed a marked fade. This result has been observed in absence of reversal agent administration.
Therefore, the present study has been designed to compare the recovery of train of four stimulation, tetanus 50 Hz and tetanus 100 Hz stimulation in patient receiving rocuronium during general anesthesia and reversed by a specific reversal agent (sugammadex). The sugammedex will be injected once two muscular contractions of the adductor pollicis muscle will be observed after a train of four stimulation, at a dose (2mg/kg) in accordance with the clinical practice worldwide admitted.
Two questions have to be investigated. First, is this dose of sugammadex sufficient to allow a complete recovery of tetanus stimulations? Second, due to the pharmacological properties of sugammadex, does a recurarisation phenomenon occur following repeated tetanus stimulations? The attented results of this study will be to propose a new thinking on what we really need to make relevant progress in the safety aspects of residual paralysis outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Residual Curarization
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TOF scan train of four ratio monitoring
Arm Type
Active Comparator
Arm Description
Recovery of train of four ratio after sugammadex administration
Arm Title
ITF device tetanus stimulation monitoring
Arm Type
Experimental
Arm Description
Recovery of tetanus 100 Hz ratio after sugamamdex administration
Intervention Type
Device
Intervention Name(s)
TOF SCAN
Intervention Description
For each included patient, 2 monitorings (TOF Scan and ITF device) will be placed, one on each hand.
Once 2 contractions of the adductor pollicis muscle will be observed on the TOF Scan side following train of four stimulation, 2 mg/kg sugammadex will be injected. Train of four ratio (delivered every minute) will be recorded.
This sequence (tetanus 100 Hz followed by tetanus 50 Hz) will be repeated 5 times For each tetanus stimulation, the ratio between the residual force and the maximum force generated by the adductor pollicis muscle will be recorded (this ratio illustrates the fade phenomenon). At the end of this period lasting 23 minutes after sugammadex administration, anesthetic drug delivery will be stopped and the patient wil be allowed to recover.
Intervention Type
Device
Intervention Name(s)
ITF
Intervention Description
For each included patient, 2 monitorings (TOF Scan and ITF device) will be placed, one on each hand.
On the ITF device side, 3 minutes after sugammadex administration, a tetanus 100 Hz stimulation will be done followed 2 minutes later by a tetanus 50 Hz stimulation.
This sequence (tetanus 100 Hz followed by tetanus 50 Hz) will be repeated 5 times For each tetanus stimulation, the ratio between the residual force and the maximum force generated by the adductor pollicis muscle will be recorded (this ratio illustrates the fade phenomenon). At the end of this period lasting 23 minutes after sugammadex administration, anesthetic drug delivery will be stopped and the patient wil be allowed to recover.
Primary Outcome Measure Information:
Title
To compare the recovery of train of four ratio with the tetanus 100 Hz ratio following sugammadex administration to reverse the rocuronium induced neuromuscular bock at the end of the surgical procedure
Description
delay following sugammadex administration to obtain a train of four ratio higher than 0.9 and a tetanus 100 Hz ratio higher than 0.9
Time Frame
23 minutes after sugammadex administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA clinical status 1 to 3
Informed consent obtained before anesthesia induction
Exclusion Criteria:
ASA clinical status 4
Emergency surgery; scheduled surgery in prone position,
Hepatic or renal disease,
BMI higher than 35,
Allergy to rocuronium or sugammadex
Facility Information:
Facility Name
C.H.U. de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Train of Four, Tetanus 50 and 100 Hz Recovery After Rocuronium Block Reversed by Sugammadex
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