NCT05003024

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

Completed NA Last updated 4 January 2022

What this trial tests

NA trial testing TOF SCAN in Postoperative Residual Curarization in 21 participants. Completed in 23 December 2021.

Timeline

6 September 2021

Primary endpoint
23 December 2021

23 December 2021

Quick facts

Lead sponsor	Poitiers University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	21
Start date	6 September 2021
Primary completion	23 December 2021
Estimated completion	23 December 2021
Sites	1 location across France

Drugs / interventions tested

• TOF SCAN
• ITF

Conditions studied

• Postoperative Residual Curarization — all drugs for Postoperative Residual Curarization →

Sponsor

Poitiers University Hospital

Who can join

Adults 18 to 80, any sex, with Postoperative Residual Curarization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of sugammadex or neostigmine for reversal of mild rocuronium paralysis using repetitive 100-Hz tetanic fade.
   Debaene B, Frasca D, Moreillon F, D'Hollander AA. · · 2025 · PMID 40340156 · DOI 10.1016/j.bja.2025.02.040