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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00970762
First received: July 23, 2009
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Anesthesia
Drug: Rocuronium 0.6 mg/kg intubating dose
Drug: Rocuronium 0.9 mg/kg intubating dose
Drug: Rocuronium 0.1 mg/kg maintenance dose
Drug: Rocuronium 0.15 mg/kg maintenance dose
Drug: Rocuronium 0.2 mg/kg maintenance
Drug: Vecuronium 0.1 mg/kg intubating dose
Drug: Vecuronium 0.025 mg/kg maintenance dose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Study of Org 9426 With Vecuronium Bromide (Phase III)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Onset time of intubating dose. DESCRIPTION: The time interval between the completion of injection of the study drug (rocuronium or vecuronium) and the maximal depression of first twitch--measured via TOF Watch Sx(R)-- was defined as the onset time. [ Time Frame: Day of Surgery, after injection of study drug until maximal depression of first twitch achieved ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects who achieved maximal block >=90% after the intubating dose. DESCRIPTION: Reaching a 90% depression of first twitch--measured via TOF Watch Sx(R)--was defined as achieving 90% block [ Time Frame: Day of Surgery, after injection of study drug until maximal depression of first twice achieved ] [ Designated as safety issue: No ]
  • Clinical duration after first maintenance dose. DESCRIPTION: The time interval between the completion of injection of study drug and return of first twitch to 25%(as measured by TOF Watch Sx(R)) was defined as the clinical duration. [ Time Frame: Day of Surgery, after injection of study drug until return of first twitch to 25% ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: February 2003
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rocuronium 0.6 INT, 0.1 MNT
Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.
Drug: Rocuronium 0.6 mg/kg intubating dose
Rocuronium 0.6 mg/kg intubating dose
Other Names:
  • Zemuron
  • Org 9426
Drug: Rocuronium 0.1 mg/kg maintenance dose
Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.
Other Names:
  • Zemuron
  • Org 9426
Experimental: Rocuronium 0.6 INT, 0.15 MNT
Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.
Drug: Rocuronium 0.6 mg/kg intubating dose
Rocuronium 0.6 mg/kg intubating dose
Other Names:
  • Zemuron
  • Org 9426
Drug: Rocuronium 0.15 mg/kg maintenance dose
Rocuronium 0.15 mg/kg maintenance dose following the intubating dose
Other Names:
  • Zemuron
  • Org 9426
Experimental: Rocuronium 0.6 INT, 0.2 MNT
Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.
Drug: Rocuronium 0.6 mg/kg intubating dose
Rocuronium 0.6 mg/kg intubating dose
Other Names:
  • Zemuron
  • Org 9426
Drug: Rocuronium 0.2 mg/kg maintenance
Rocuronium 0.2 mg/kg maintenance dose following the intubating dose
Other Names:
  • Zemuron
  • Org 9426
Experimental: Rocuronium 0.9 INT, 0.1 MNT
Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.
Drug: Rocuronium 0.9 mg/kg intubating dose
0.9 mg/kg intubating dose of rocuronium
Other Names:
  • Zemuron
  • Org 9426
Drug: Rocuronium 0.1 mg/kg maintenance dose
Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.
Other Names:
  • Zemuron
  • Org 9426
Experimental: Rocuronium 0.9 INT, 0.15 MNT
Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.
Drug: Rocuronium 0.9 mg/kg intubating dose
0.9 mg/kg intubating dose of rocuronium
Other Names:
  • Zemuron
  • Org 9426
Drug: Rocuronium 0.15 mg/kg maintenance dose
Rocuronium 0.15 mg/kg maintenance dose following the intubating dose
Other Names:
  • Zemuron
  • Org 9426
Experimental: Rocuronium 0.9 INT, 0.2 MNT
Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.
Drug: Rocuronium 0.9 mg/kg intubating dose
0.9 mg/kg intubating dose of rocuronium
Other Names:
  • Zemuron
  • Org 9426
Drug: Rocuronium 0.2 mg/kg maintenance
Rocuronium 0.2 mg/kg maintenance dose following the intubating dose
Other Names:
  • Zemuron
  • Org 9426
Active Comparator: Vecuronium 0.1 INT, 0.025 MNT
Participants in this group received a 0.1 mg/kg intubating dose of vecuronium followed by 0.025 mg/kg maintenance dose of vecuronium.
Drug: Vecuronium 0.1 mg/kg intubating dose
Vecuronium 0.1 mg/kg intubating dose
Other Name: Norcuron
Drug: Vecuronium 0.025 mg/kg maintenance dose
Vecuronium 0.025 mg/kg maintenance dose following the intubating dose
Other Name: Norcuron

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00970762     History of Changes
Other Study ID Numbers: P05975, 71101
Study First Received: July 23, 2009
Last Updated: May 7, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Rocuronium
Vecuronium Bromide
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014