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

Not Applicable

Completed

• Conditions: Postoperative Residual Curarization
• Interventions: Device: TOF SCAN; Device: ITF

• Registration Number: NCT05003024
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-12
• Study Start: 2021-09-06
• Primary Completion: 2021-12-23
• Study Completion: 2021-12-23
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TOF scan train of four ratio monitoring	TOF SCAN	Recovery of train of four ratio after sugammadex administration
ITF device tetanus stimulation monitoring	ITF	Recovery of tetanus 100 Hz ratio after sugamamdex administration

Primary Outcome Measures

Name	Time	Method
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	23 minutes after sugammadex administration	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

Trial Locations

Locations (1)

C.H.U. de Poitiers; 🇫🇷 Poitiers, France