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

Merck Sharp & Dohme (MSD) logo

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)

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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