Comparative Study of Rocuronium With Vecuronium (Study 71101)(COMPLETED)

Comparative Study of Org 9426 With Vecuronium Bromide (Phase III)

This study was conducted to determine and compare the safety and effectiveness of two neuromuscular blockers (rocuronium and vecuronium) at various doses in adults who are undergoing general elective surgery with sevoflurane anesthesia.

Study participants received an intubating dose of a neuromuscular blocker (to enable insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation). The intubating dose was followed by repeated bolus maintenance doses as needed, to maintain muscle relaxation. The time it takes to reach maximal effect of the neuromuscular blocker (onset time) after the intubating dose was measured and compared as the primary outcome.

The TOF Watch-SX (acceleration transducer) was used in the measurement of neuromuscular blocking action.

Inclusion criteria:

• at least 20 but under 65 years of age
• American Society of Anesthesiologists (ASA) Class 1, 2 or 3 for general elective surgery
• not considered to be pregnant
• scheduled for elective surgery under sevoflurane or propofol anesthesia with an anticipated duration of about 1.5-3 hours
• normal laboratory values

Exclusion Criteria:

• certain medical conditions or medical histories
• receiving certain medications or treatments