Anesthesia
Conditions
Brief 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.
Detailed description
The TOF Watch-SX (acceleration transducer) was used in the measurement of neuromuscular blocking action.
Interventions
DRUGRocuronium 0.6 mg/kg intubating dose
Rocuronium 0.6 mg/kg intubating dose
DRUGRocuronium 0.9 mg/kg intubating dose
0.9 mg/kg intubating dose of rocuronium
DRUGRocuronium 0.1 mg/kg maintenance dose
Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.
DRUGRocuronium 0.15 mg/kg maintenance dose
Rocuronium 0.15 mg/kg maintenance dose following the intubating dose
DRUGRocuronium 0.2 mg/kg maintenance
Rocuronium 0.2 mg/kg maintenance dose following the intubating dose
DRUGVecuronium 0.1 mg/kg intubating dose
Vecuronium 0.1 mg/kg intubating dose
DRUGVecuronium 0.025 mg/kg maintenance dose
Vecuronium 0.025 mg/kg maintenance dose following the intubating dose
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Day of Surgery, after injection of study drug until maximal depression of first twitch achieved |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 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. | Day of Surgery, after injection of study drug until return of first twitch to 25% |
Outcome results
None listed