Comparison of 2.0 mg/kg Sugammadex and Neostigmine at Reappearance of T2 in Chinese and European Subjects (Study 19.4.324)(P05768AM1)(COMPLETED)

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Study arms

• Experimental
  Sugammadex in Caucasian Subjects

  At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.

  Drug: Sugammadex

• Active comparator
  Neostigmine in Caucasian Subjects

  At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.

  Drug: neostigmine

• Experimental
  Sugammadex in Chinese Subjects

  At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.

  Drug: Sugammadex

• Active comparator
  Neostigmine in Chinese Subjects

  At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.

  Drug: neostigmine

Interventions

• DrugSugammadex

  After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 2.0 mg/kg sugammadex was administered.

  Also known as: Org 25969, Bridion®

• Drugneostigmine

  After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 50 µg/kg neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.

  Also known as: Neostigmine with atropine

Primary outcomes

1. Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9.

   Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation was to continue until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached \>= 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery. The primary analysis was the comparison between sugammadex \& neostigmine among Chinese subjects; other comparisons were secondary.

   Time frame: start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade

Secondary outcomes

1. Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 and 0.8.

   Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.

   Time frame: start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade

Baseline characteristics

Publications

• Wu X, Oerding H, Liu J, Vanacker B, Yao S, Dahl V, Xiong L, Claudius C, Yue Y, Huang Y, Abels E, Rietbergen H, Woo T. Rocuronium blockade reversal with sugammadex vs. neostigmine: randomized study in Chinese and Caucasian subjects. BMC Anesthesiol. 2014 Jul 12;14:53. doi: 10.1186/1471-2253-14-53. eCollection 2014. PubMed 25187755 ↗