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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00970762
First Posted: September 2, 2009
Last Update Posted: April 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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 ]
  • 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% ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00970762     History of Changes
Other Study ID Numbers: P05975
71101
First Submitted: July 23, 2009
First Posted: September 2, 2009
Last Update Posted: April 17, 2015
Last Verified: April 2015

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