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

NCT05003024 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-01-04

No results posted yet for this study

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.

Conditions

  • Postoperative Residual Curarization

Interventions

DEVICE

TOF SCAN

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.

DEVICE

ITF

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.

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-06
Primary Completion
2021-12-23
Completion
2021-12-23

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05003024 on ClinicalTrials.gov