Comparison of Train of Four, Tetanus 50 and 100 Hz Recovery After Rocuronium Block Reversed by Neostigmine

Postoperative Residual Curarization Clinical Trial

— DECURATOF 2  

Official title:

Comparison of Train of Four, Tetanus 50 Hz and Tetanus 100 Hz Recovery Following Rocuronium Induced Neuromuscular Block Reversed by Neostigmine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05224648
• Other study ID #: DECURATOF 2
• Status: Completed
• Phase: N/A
• Start date: June 22, 2022
• Est. completion date: November 18, 2022

Study information

• Verified date: January 2023
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 threshold 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 an anticholinesterase agent (neostigmine). Neostigmine will be injected once four muscular contractions of the adductor pollicis muscle will be observed after a train of four stimulation, at a dose (40 µg/kg) in accordance with the clinical practice worldwide admitted. Two questions have to be investigated. First, is this dose of neostigmine sufficient to allow a complete recovery of tetanus stimulations ? Second, due to the pharmacological properties of neostigmine, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 18, 2022
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 neostigmine

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Postoperative Residual Curarization
• Tetanus

Intervention

Device:
• TOF scan train of four ratio monitoring
Device : TOF Scan For each included patient, 2 monitorings (TOF Scan and ITF device) will be placed, one on each hand. Once 4 contractions of the adductor pollicis muscle will be observed on the TOF Scan side following train of four stimulation, 40 µg/kg neostigmine 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 6 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 30 minutes after neostigmine administration, anesthetic drug delivery will be stopped and the patient wil be allowed to recover.
• ITF device tetanus stimulation monitoring
Device ITF For each included patient, 2 monitorings (TOF Scan and ITF device) will be placed, one on each hand. Once 4 contractions of the adductor pollicis muscle will be observed on the TOF Scan side following train of four stimulation, 40 µg/kg neostigmine 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 6 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 30 minutes after neostigmine administration, anesthetic drug delivery will be stopped and the patient wil be allowed to recover.

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	To determine the delay following neostigmine administration to obtain a train of four ratio higher than 0.9 and a tetanus 100 Hz ratio higher than 0.9		30 minutes after neostigmine administration