Comparison of Train of Four, Tetanus 50 and 100 Hz Recovery After Rocuronium Block Reversed by Neostigmine (DECURATOF 2)

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Residual Curarization
• Intervention / Treatment: Device: TOF scan train of four ratio monitoring; Device: ITF device tetanus stimulation monitoring

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86021
    • Chu de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TOF scan train of four ratio monitoring; recovery of train of four ratio after neostigmine administration	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.
Experimental: ITF device tetanus stimulation monitoring; recovery of tetanus 100 Hz and tetanus 50 Hz ratio after neostigmine administration	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Study Director: Bertrand Debaene, MD phD, CHU de Poitiers FRANCE

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Actual): November 17, 2022
• Study Completion (Actual): November 18, 2022

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Clostridium Infections; Tetanus; Delayed Emergence from Anesthesia
• Other Study ID Numbers: DECURATOF 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No