Comparative Study of Rocuronium With Vecuronium (Study 71101)(COMPLETED)
NCT ID: NCT00970762
Last Updated: 2015-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
90 participants
INTERVENTIONAL
2003-02-28
2004-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Rocuronium 0.6 mg/kg intubating dose
Rocuronium 0.6 mg/kg intubating dose
Rocuronium 0.1 mg/kg maintenance dose
Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.
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.
Rocuronium 0.6 mg/kg intubating dose
Rocuronium 0.6 mg/kg intubating dose
Rocuronium 0.15 mg/kg maintenance dose
Rocuronium 0.15 mg/kg maintenance dose following the intubating dose
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.
Rocuronium 0.6 mg/kg intubating dose
Rocuronium 0.6 mg/kg intubating dose
Rocuronium 0.2 mg/kg maintenance
Rocuronium 0.2 mg/kg maintenance dose following the intubating dose
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.
Rocuronium 0.9 mg/kg intubating dose
0.9 mg/kg intubating dose of rocuronium
Rocuronium 0.1 mg/kg maintenance dose
Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.
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.
Rocuronium 0.9 mg/kg intubating dose
0.9 mg/kg intubating dose of rocuronium
Rocuronium 0.15 mg/kg maintenance dose
Rocuronium 0.15 mg/kg maintenance dose following the intubating dose
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.
Rocuronium 0.9 mg/kg intubating dose
0.9 mg/kg intubating dose of rocuronium
Rocuronium 0.2 mg/kg maintenance
Rocuronium 0.2 mg/kg maintenance dose following the intubating dose
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.
Vecuronium 0.1 mg/kg intubating dose
Vecuronium 0.1 mg/kg intubating dose
Vecuronium 0.025 mg/kg maintenance dose
Vecuronium 0.025 mg/kg maintenance dose following the intubating dose
Interventions
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Rocuronium 0.6 mg/kg intubating dose
Rocuronium 0.6 mg/kg intubating dose
Rocuronium 0.9 mg/kg intubating dose
0.9 mg/kg intubating dose of rocuronium
Rocuronium 0.1 mg/kg maintenance dose
Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.
Rocuronium 0.15 mg/kg maintenance dose
Rocuronium 0.15 mg/kg maintenance dose following the intubating dose
Rocuronium 0.2 mg/kg maintenance
Rocuronium 0.2 mg/kg maintenance dose following the intubating dose
Vecuronium 0.1 mg/kg intubating dose
Vecuronium 0.1 mg/kg intubating dose
Vecuronium 0.025 mg/kg maintenance dose
Vecuronium 0.025 mg/kg maintenance dose following the intubating dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* receiving certain medications or treatments
20 Years
65 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Other Identifiers
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71101
Identifier Type: -
Identifier Source: secondary_id
P05975
Identifier Type: -
Identifier Source: org_study_id
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