Clinical Trial: Sugammadex/Neostigmine and Liver Transplantation
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Sugammadex Versus Neostigmine After Rocuronium Infusion During Liver Transplantation
Brief Summary:
Cirrhotic patients undergoing liver transplantation are at very high risk of post operative complication such as post-operative residual curarization.
Rocuronium is a neuromuscular blocking agent that nowadays can be safely and rapidly antagonized with sugammadex.
No one study compared sugammadex versus neostigmine after rocuronium infusion during liver transplantation.
Detailed Summary:
It is known that major abdominal surgery is associated with increased risk of morbidity and postoperative mortality. The complexity and the duration of the procedure as well as the failure to antagonize neuromuscular blocking agents at the end of surgical procedure are risk factors for postoperative complications.
Muscle relaxation plays an important role that is to facilitate intubation and to allow a better surgical condition. For this reason it is necessary to maintain, during the surgery, a deep neuromuscular block.
Deep block at the level of the adductor muscle of the thumb is obtained by measuring 1-2 responses during post-tetanic stimulation (the so-called Post-Tetanic Count or PTC).
The maintenance of a deep neuromuscular block requires further doses of neuromuscular blockers and, therefore, the need of long recovery times regardless of the drug used.
Pharmacodynamics and pharmacokinetics of neuromuscular blocking and reversals commonly used in clinical practice can undergo significant changes due to the presence of alterations in organ function such as hepatic and renal insufficiency. In these patients we see more frequent adverse events such as prolonged neuromuscular blockade and postoperative residual curarization.
In the literature it is considered suitable a recovery from neuromuscular block if the relationship between the fourth and first contraction during Train of Four (TOF) is greater than 0.9 (TOF-ratio> 0.9). This may take a long time so the reversal of blocking agents at the end of the surgical procedure is the solution to reduce this waiting period. The importance of an adequate recovery from neuromuscular block at the end of anesthesia is related to
Sponsor: Azienda Ospedaliera S. Maria della Misericordia
Current Primary Outcome: Recovery time from moderate neuromuscular block to a TOF ratio more than 0.9 after administration of sugammadex or neostigmine using TOF-Watch SX. [ Time Frame: 30 minutes ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Any episode PORC (defined as TOF ratio less than 0.9) within 20 minutes after extubation of the patient using TOF-Watch SX. [ Time Frame: 20 minutes ]
Original Secondary Outcome: Same as current
Information By: Azienda Ospedaliera S. Maria della Misericordia
Dates:
Date Received: February 13, 2016
Date Started: January 2014
Date Completion: March 2017
Last Updated: January 28, 2017
Last Verified: February 2016
