Sugammadex and Heart Failure

Postoperative Neuromuscular Block Clinical Trial

Official title:

Reversal of Rocuronium-induced Neuromuscular Block With Sugammadex in Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509651
• Other study ID #: B126201112363
• Status: Completed
• Phase: Phase 3
• First received: January 1, 2012
• Last updated: April 3, 2012
• Start date: January 2012
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Onze Lieve Vrouw Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Neuromuscular Block

Intervention

Drug:
• Sugammadex
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.

Locations

Country	Name	City	State
Belgium	OLV Hospital	Aalst

Sponsors (1)

Lead Sponsor	Collaborator
Onze Lieve Vrouw Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Adverse hemodynamic events.		From anesthesia induction until 3h after arrival in the postanaesthesia care unit (PACU).	Yes
Secondary	Adverse respiratory events (SpO2 <90% and/or signs of airway obstruction).		From arrival in the PACU until 30min thereafter.	Yes