We will compare usual care (neostigmine) with sugammadex for reversal of a moderate rocuronium-induced neuromuscular blockade and assess the effect on diaphragmatic EMG activity of sugammadex versus neostigmine.
Conditions
Interventions
Trade Name: ROBINUL®-NEOSTIGMINE
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Trade N
Sponsors
Onze-Lieve-Vrouw Ziekenhuis
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: A subject is only eligible and may enter the study, if all of the following criteria are met: 1. Only male, healthy volunteers will be enrolled after an in-depth interview 2. Each participant must have the mental capacity to decide whether he takes part in the trial or not. Each participant must voluntarily give his written informed consent. 3. Each participant must be between 18 and 35 (inclusive) years of age at the screening visit 4. Each participant must meet the American Society of Anaesthesiologists class I criteria. 5. Subject has a Body Mass Index (BMI) = 26 kg/m2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Volunteers may not have participated in a drug study within 90 days prior to dosing. A subject is ineligible and may not enter the study, if any of the following conditions are observed: 1. Known or suspected to have a neuromuscular disorder. 2. Use of medications known to interfere with NMBAs. 3. Known or suspected allergic reaction to sugammadex, neostigmine, rocuronium, anaesthetic or narcotic medications, or any drugs used during general anaesthesia. 4. Known or suspected to have an anatomical malformation impeding a proper intubation. 5. Family or personal history of problems related to anaesthesia. 6. Known or suspected to have a history of malignant hyperthermia. 7. Known to have a renal insufficiency. 8. Current smoker or history of smoking. 9. Drinking more than 2 consumptions of alcohol a day. 10. Known or suspected to have a chronic obstructive pulmonary disease GOLD classification 2 or higher. 11. Known to have an infection of the upper or lower airways, as diagnosed by clinical findings. 12. Reflux oesophagitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of the effect on diaphragmatic EMG activity of sugammadex versus neostigmine. To assess diaphragmatic activity, a transesophageal EMG recorder can be used, like the NAVA catheter (“Neurally Adjusted Ventilatory Assist”). Recent reports use the EMG signal obtained via a NAVA catheter during the weaning process as a marker for weaning failure. The reports link electromyographic activity of the diaphragm (Edi)-derived indices to the rapid shallow breathing index, a commonly used parameter to assess weaning outcome. We propose a double blind randomised trial in healthy volunteers, to assess the different effects of sugammadex and neostigmine on the central respiratory drive, neuromechanical coupling and diaphragm strength. ;Secondary Objective: Assessment of the effect of neostigmine and sugammadex on the central respiratory drive and neuroventilatory efficiency, including diaphragmatic fatigue.;Primary end point(s): At the end of surgery when spontaneous breathing is resumed, good diaphragmatic function is essential. When faced with a certain degree of residual neuromuscular block (RNMB, or PostOperative Residual Curarization, PORC) anaesthetists nowadays have the option to choose between an acetylcholinesterase inhibitor (AchEI, e.g. neostigmine) or a selective relaxant binding agent (SRBA, sugammadex). Sugammadex can only be used with the steroidal neuromuscular blocking agents (NMBAs), like vecuronium and rocuronium. A sugammadex dosage of 2 mg/kg is recommended in case of spontaneous recovery up to at least the reappearance of the second twitch of the train-of-four (TOF, T2) following a rocuronium induced blockade. The use of neostigmine 70µg/kg on reappearance of the second TOF response, was described by Kirkegaard and colleagues. Our hypothesis is that by making nicotinergic acetylcholine receptors fee from rocuronium in the diaphragmatic neuromuscular junctions, instead of increasing the amount of acetylcholine, sugammadex will result | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adverse Events will be recorded.;Timepoint(s) of evaluation of this end point: Throughout the procedure. | — |
Countries
Belgium
Contacts
Public ContactResearch Unit Anaesthesia&CCM
Onze-Lieve-Vrouw Ziekenhuis
Outcome results
None listed