Neuromuscular Block Clinical Trial
Official title:
A Randomized Double Blind Trial Comparing Reversal With Low Doses Of Sugammadex aFter Rocuronium-induced Neuromuscular Block Under General Anesthesia in Patients Undergoing Non-cardiac Surgery(TOF TRIAL)
Neuromuscular blocking agents (NMBA) are among the most commonly used drugs during general
anesthesia and may induce complete muscle paralysis.They are used clinically to facilitate
endotracheal intubation and to optimize surgical working conditions. Incomplete recovery from
non-depolarising NMBAs continues to be a common problem in modern postoperative care unit and
is associated with significant risk of microaspiration and hypoventilation which leads to
pulmonary complications.Recently effective reversal of neuromuscular blockade has been
described by use of lower dose of sugammadex the recommended without providing adequate
answer to whether the lower dose is safe enough to avoid recurrent block.
Hypotheses:
1. Administration of sugammadex 0.25 mg/kg at TOF ratio 0.3 will successfully reverse
(TOF=0.9) rocuronium induced neuromuscular block within 10 min.
2. Recurrent block (TOF ratio < 0.9) does not occur after reversal with low dose sugammadex
0.25 mg/kg.
The primary objective of this trial is to assess the dose-response characteristics of
sugammadex in reversing rocuronium induced neuromuscular block and to identify the minimal
effective dose
Secondary objective is to assess the safety of different doses of sugammadex (recurrent block
(TOF ratio < 0.9) after reversal and the occurrence of adverse reactions)
Sugammadex is a very expensive drug which limits its use i anaesthesia department. By
optimising drug dosage it may have economic impact and contribute to a wider use of
sugammadex to reverse neuromuscular block before extubation and thus avoid incomplete
recovery. This may lead to less risk for postoperative pulmonary complications and thereby
reduce morbidity and mortality after surgery.
Doses of study drug will be 0 mg/kg Ideal Body Weight (IBW), 0.25 mg/kg IBW, 0.50 mg/kg IBW, 1.0 mg/kg IBW and 2.0 mg/kg IBW. TOF will be measured every 10th second until full reversal. ;
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