Postoperative Neuromuscular Block
Conditions
Keywords
antagonists neuromuscular block, neuromuscular block, monitoring, neuromuscular function
Brief summary
Although anticholinesterase reversal agents have been used in combination with anticholinergic drugs for over half a century, it has been suggested that they should be used with caution in patients with underlying cardiovascular disease. As sugammadex has no endogenous targets, it is unlikely to cause any adverse cardiovascular effects. This selective relaxant binding agent is specifically designed to encapsulate rocuronium, which can, therefore, promptly restore neuromuscular function regardless of any levels of NMB as the dose is increased. Some reports, however, suggest that sugammadex may have increased time to effect in some patient populations like the elderly, patients in intensive care and renal failure patients. A less dynamic circulation and increased transfer time to the effector site in these subjects are likely explanations for this effect. The present trial was designed to assess the safety and efficacy of sugammadex 2.0 mg kg-1 for the reversal of rocuronium-induced NMB in patients with heart failure.
Interventions
DRUGSugammadex
After the induction of anaesthesia, monitoring neuromuscular function is initiated and performed continuously using the TOF-Watch SX (Organon Ireland Ltd, Ireland) at the thumb. Repetitive train-of four (TOF) stimulation is applied every 15 s at the ulnar nerve until the end of anaesthesia, at least until recovery of the TOF ratio to 0.9 after administration of sugammadex. Each patient receives a single IV bolus dose of rocuronium 0.6 mg kg-1, after which tracheal intubation is performed. Maintenance doses of rocuronium 0.1 mg kg-1, are permitted as required and administered at the reappearance of the second twitch in the TOF. On reappearance of the second twitch at the end of surgery, patients receive a single IV bolus dose of sugammadex, 2.0 mg kg-1, for reversal.
Sponsors
Onze Lieve Vrouw Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* aged 18 yr or older * categorized as American Society of Anesthesiologists class 3-4 and New York Heart Association class 2-4 * with an ejection fraction \<25% * scheduled to undergo elective surgery for cardiac resynchronization therapy, an automated implantable cardioverter-defibrillator (ICD), or battery replacement of an ICD or biventricular pacemaker, during general anaesthesia.
Exclusion criteria
* expected to have a difficult intubation for anatomic reasons * they had a neuromuscular disorder * a personal or family history of malignant hyperthermia * or known allergy to medication used during general anaesthesia * not able or willing to give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time from start of sugammadex administration to recovery of the train-of-four (TOF) ratio to 0.9. | Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min |
Secondary
| Measure | Time frame |
|---|---|
| The time from start of sugammadex administration to recovery of the TOF ratio to 0.7 and 0.8. | Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min |
| Adverse hemodynamic events. | From anesthesia induction until 3h after arrival in the postanaesthesia care unit (PACU). |
| Adverse respiratory events (SpO2 <90% and/or signs of airway obstruction). | From arrival in the PACU until 30min thereafter. |
Countries
Belgium
Outcome results
None listed