Comparison of Recovery From Rocuronium 1.2 mg/kg Followed By Org 25969 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(COMPLETED)

The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg Zemuron® after reversal at 3 minutes by 16.0 mg/kg of Org 25969 compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.

• Drug: Sugammadex
  Subjects were to receive an intubating dose of 1.2 mg/kg rocuronium followed by 16.0 mg/kg Org 25969 three minutes after the start of rocuronium administration.
  Other Name: Org 25969
• Drug: succinylcholine
  Subjects were to receive an intubation dose of 1.0 mg/kg succinylcholine and allowed to recovery spontaneously from neuromuscular blockade.

• Experimental: 1
  rocuronium plus Org 25969
  Intervention: Drug: Sugammadex
• Active Comparator: 2
  succinylcholine
  Intervention: Drug: succinylcholine

Inclusion Criteria:

• ASA Class 1 or 2;
• 18 to 65 years of age (inclusive);
• Scheduled for elective surgical procedure under general anesthesia requiring a short duration of neuromuscular block with the use of rocuronium or succinylcholine and requiring endotracheal intubation;
• Scheduled for surgery in supine position;
• Body mass index (BMI) < 30;
• Given written informed consent.

Exclusion Criteria:

• Subjects with ischemic heart disease or history of myocardial infarction within the last year;
• Subjects in whom a difficult intubation is expected due to anatomical malformations;
• Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;
• Subjects known or suspected to have a (family) history of malignant hyperthermia;
• Subjects known or suspected to have an allergy to narcotics, muscle relaxants, midazolam, anesthetics or other medications used during surgery;
• Subjects receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
• Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
• Female subjects who are pregnant or breast-feeding;
• Females subjects of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD, abstinence];
• Subjects who had already participated in a Org 25969 trial including Protocol 19.4.303;