Comparing 4.0 mg.Kg-1 Sugammadex With Placebo in the Reversal of Profound Neuromuscular Blockade (P05767)

A Randomized, Safety-assessor Blinded Trial Comparing 4.0 mg.Kg-1 Sugammadex With Placebo in Adult Subjects Scheduled for Surgery Requiring Profound Neuromuscular Blockade

The current trial was designed to demonstrate faster recovery in participants undergoing elective surgeries requiring profound neuromuscular blockade induced by rocuronium to a fourth twitch/first twitch (T4/T1) ratio of 0.9, after reversal of a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 Sugammadex compared to Placebo, to evaluate the safety of 4.0 mg.kg-1 Sugammadex and to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay for these participants.

Inclusion Criteria:

• Male or female participants
• American Society of Anesthesiologists (ASA) class 1, 2 or 3
• Age >=18 years
• Scheduled to undergo a surgery requiring profound NMB such as cardiovascular, gynaecologic, neurologic and thoracic surgical procedures under general anesthesia requiring neuromuscular relaxation with rocuronium for endotracheal intubation and if applicable maintenance of NMB in a position allowing neuromuscular monitoring
• Given written informed consent

Exclusion Criteria:

• Participants known or suspected to have neuromuscular disorders affecting NMB