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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Anesthesia

Treatments: Drug: Rocuronium 0.2 mg/kg maintenance; Drug: Rocuronium 0.6 mg/kg intubating dose; Drug: Rocuronium 0.1 mg/kg maintenance dose; Drug: Rocuronium 0.15 mg/kg maintenance dose; Drug: Vecuronium 0.1 mg/kg intubating dose; Drug: Rocuronium 0.9 mg/kg intubating dose; Drug: Vecuronium 0.025 mg/kg maintenance dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00970762

71101

P05975

Details and patient eligibility

About

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.

Full description

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

Enrollment: 90 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 7 patient groups

Rocuronium 0.6 INT, 0.1 MNT

Experimental group

Description:

Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.

Treatment:

Drug: Rocuronium 0.1 mg/kg maintenance dose

Drug: Rocuronium 0.6 mg/kg intubating dose

Rocuronium 0.6 INT, 0.15 MNT

Experimental group

Description:

Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.

Treatment:

Drug: Rocuronium 0.15 mg/kg maintenance dose

Drug: Rocuronium 0.6 mg/kg intubating dose

Rocuronium 0.6 INT, 0.2 MNT

Experimental group

Description:

Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.

Treatment:

Drug: Rocuronium 0.2 mg/kg maintenance

Drug: Rocuronium 0.6 mg/kg intubating dose

Rocuronium 0.9 INT, 0.1 MNT

Experimental group

Description:

Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.

Treatment:

Drug: Rocuronium 0.9 mg/kg intubating dose

Drug: Rocuronium 0.1 mg/kg maintenance dose

Rocuronium 0.9 INT, 0.15 MNT

Experimental group

Description:

Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.

Treatment:

Drug: Rocuronium 0.9 mg/kg intubating dose

Drug: Rocuronium 0.15 mg/kg maintenance dose

Rocuronium 0.9 INT, 0.2 MNT

Experimental group

Description:

Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.

Treatment:

Drug: Rocuronium 0.9 mg/kg intubating dose

Drug: Rocuronium 0.2 mg/kg maintenance

Vecuronium 0.1 INT, 0.025 MNT

Active Comparator group

Description:

Participants in this group received a 0.1 mg/kg intubating dose of vecuronium followed by 0.025 mg/kg maintenance dose of vecuronium.

Treatment:

Drug: Vecuronium 0.025 mg/kg maintenance dose

Drug: Vecuronium 0.1 mg/kg intubating dose