Clinical trial NCT01509651: Sugammadex and Heart Failure
Official title: Reversal of Rocuronium-induced Neuromuscular Block With Sugammadex in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Neuromuscular Block
Keywords: antagonists neuromuscular block
neuromuscular block, monitoring
neuromuscular function
Lead sponsor: Onze Lieve Vrouw Hospital
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The time from start of sugammadex administration to recovery of the train-of-four (TOF) ratio to 0.9.
timeFrame: Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min
Secondary outcomes:
measure: The time from start of sugammadex administration to recovery of the TOF ratio to 0.7 and 0.8.
timeFrame: Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min
measure: Adverse hemodynamic events.
timeFrame: From anesthesia induction until 3h after arrival in the postanaesthesia care unit (PACU).
measure: Adverse respiratory events (SpO2 <90% and/or signs of airway obstruction).
timeFrame: From arrival in the PACU until 30min thereafter.
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Hospital
Study officials:
affiliation: OLV Hospital, Anesthesiology and CCM, Aalst, Belgium
name: Guy Cammu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sorgenfrei IF, Norrild K, Larsen PB, Stensballe J, Ostergaard D, Prins ME, Viby-Mogensen J. Reversal of rocuronium-induced neuromuscular block by the selective relaxant binding agent sugammadex: a dose-finding and safety study. Anesthesiology. 2006 Apr;104(4):667-74. doi: 10.1097/00000542-200604000-00009.
citation: Dahl V, Pendeville PE, Hollmann MW, Heier T, Abels EA, Blobner M. Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery. Eur J Anaesthesiol. 2009 Oct;26(10):874-84. doi: 10.1097/EJA.0b013e32832c605b.
citation: Suzuki T, Kitajima O, Ueda K, Kondo Y, Kato J, Ogawa S. Reversibility of rocuronium-induced profound neuromuscular block with sugammadex in younger and older patients. Br J Anaesth. 2011 Jun;106(6):823-6. doi: 10.1093/bja/aer098. Epub 2011 Apr 29.
citation: Staals LM, Snoeck MM, Driessen JJ, Flockton EA, Heeringa M, Hunter JM. Multicentre, parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in patients with end-stage renal failure or normal renal function. Br J Anaesth. 2008 Oct;101(4):492-7. doi: 10.1093/bja/aen216. Epub 2008 Jul 23.