Comparative Study of Rocuronium With Vecuronium (Study 71101)(COMPLETED)
NCT00970762 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2015-04-17
Summary
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.
Conditions
- Anesthesia
Interventions
- DRUG
-
Rocuronium 0.6 mg/kg intubating dose
Rocuronium 0.6 mg/kg intubating dose
- DRUG
-
Rocuronium 0.9 mg/kg intubating dose
0.9 mg/kg intubating dose of rocuronium
- DRUG
-
Rocuronium 0.1 mg/kg maintenance dose
Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.
- DRUG
-
Rocuronium 0.15 mg/kg maintenance dose
Rocuronium 0.15 mg/kg maintenance dose following the intubating dose
- DRUG
-
Rocuronium 0.2 mg/kg maintenance
Rocuronium 0.2 mg/kg maintenance dose following the intubating dose
- DRUG
-
Vecuronium 0.1 mg/kg intubating dose
Vecuronium 0.1 mg/kg intubating dose
- DRUG
-
Vecuronium 0.025 mg/kg maintenance dose
Vecuronium 0.025 mg/kg maintenance dose following the intubating dose
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-02-28
- Primary Completion
- 2004-02-29
- Completion
- 2004-02-29
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