decurarisation
Conditions
Interventions
Trade Name: Bridion
Product Name: Sugammadex
Pharmaceutical Form: Solution for injection
INN or Proposed INN: sugammadex sodium
CAS Number: 343306-79-6
Other descriptive name: SUGAMMADEX
Concentration
Sponsors
Universitair Ziekenhuis Brussel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients scheduled to undergo elective maxillofacial surgical procedures with an expected duration of general anaesthesia of more than one hour - 18–65 years - body mass index 18.5–25.0 kg/m² - ASA I–II - general anesthesia with naso- or orotracheal intubation requiring only deep neuromusculair block (NMB) for the intubation procedure. - Male-to-female allocation ratio 1:1 was respected at patient selection. 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - suspected difficult airway - bronchial asthma - chronic obstructive pulmonary disease - neuromuscular disease - suspected malignant hyperthermia - significant hepatic or renal dysfunction - glaucoma - allergy to the drugs used in this trial, and taking medication known to influence the effect of NMBAs. - Patients who participated in another study in =1 month will not be included - pregnant or breastfeeding patients. The following medications are known to interact with NMB (neuromuscular blocker): - Tetracyclines, aminoglycosides, polymyxins, and clindamycin potentiate neuromuscular blockade through inhibition of acetylcholine (ACh) release or desensitization of postjunctional nAChRs to ACh - Patients receiving chronic treatment of anti-epileptic drugs are relatively resistant to nondepolarizing NMBAs due to accelerated clearance of these drugs - Patients who take lithium can have a prolonged response to both depolarizing and nondepolarizing NMBAs - In laboratory studies, sertraline and amitriptyline inhibit butyrylcholinesterase - Local anesthetics (LAs) may enhance the effects of both depolarizing and nondepolarizing NMBAs through pre- and post-synaptic interactions at the neuromuscular junction (NMJ) Data on the effects of lidocaine on neuromuscular block are conflicting. Whereas one study reported that epidural lidocaine potentiated vecuronium-induced neuromuscular block , several studies have reported no effect of intravenous (IV) lidocaine on the onset, duration, or recovery from rocuronium-induced neuromuscular block ,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The goal of the investigator is to find the ED50 (effective dose) for sugammadex to antagonize a deep rocuronium-induced neuromuscular block, and thus find the lowest dose of sugammadex that is still safe for clinical use.;Secondary Objective: -Finding the ED50 with 10% precision in a later stage -Finding the dosage, and its corresponding time to act, needed to antagonize a deep rocuronium-induced neuromuscular block -Determing if there is a threshold for the dose of sugammadex to ensure that there will be no recurarisation when antagonizing a deep rocuronium-induced neuromuscular block within 1 hour -Creating a guideline for the clinical doses of sugammadex depending on every level of rocuronium-induced neuromuscular block -Adverse events in all participants ;Primary end point(s): - Finding the ED50 with 20% precision in the first stage;Timepoint(s) of evaluation of this end point: TOF (Train of four) - first phase: every 15 seconds between 3 minutes and 15 minutes after injection - second phase: every 5 minutes between 15 minutes and 60 minutes after injection PTC (post tetanic count) - every 3 minutes between 3 minutes and 60 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Belgium
Contacts
Public ContactVeerle Van Mossevelde
Universitair Ziekenhuis Brussel
Outcome results
None listed