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| ID | Type | Description | Link |
|---|---|---|---|
| 71101 |
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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.
The TOF Watch-SX (acceleration transducer) was used in the measurement of neuromuscular blocking action.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rocuronium 0.6 INT, 0.1 MNT | Experimental | Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium. |
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| Rocuronium 0.6 INT, 0.15 MNT | Experimental | Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium. |
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| Rocuronium 0.6 INT, 0.2 MNT | Experimental | Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium. |
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| Rocuronium 0.9 INT, 0.1 MNT | Experimental | Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium. |
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| Rocuronium 0.9 INT, 0.15 MNT | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium 0.6 mg/kg intubating dose | Drug | Rocuronium 0.6 mg/kg intubating dose |
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| Measure | Description | 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 |
| Measure | Description | 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. |
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Inclusion criteria:
Exclusion Criteria:
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Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.
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| Rocuronium 0.9 INT, 0.2 MNT | Experimental | Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium. |
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| Vecuronium 0.1 INT, 0.025 MNT | Active Comparator | Participants in this group received a 0.1 mg/kg intubating dose of vecuronium followed by 0.025 mg/kg maintenance dose of vecuronium. |
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| Rocuronium 0.9 mg/kg intubating dose | Drug | 0.9 mg/kg intubating dose of rocuronium |
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| Rocuronium 0.1 mg/kg maintenance dose | Drug | Rocuronium 0.1 mg/kg maintenance dose following the intubating dose. |
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| Rocuronium 0.15 mg/kg maintenance dose | Drug | Rocuronium 0.15 mg/kg maintenance dose following the intubating dose |
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| Rocuronium 0.2 mg/kg maintenance | Drug | Rocuronium 0.2 mg/kg maintenance dose following the intubating dose |
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| Vecuronium 0.1 mg/kg intubating dose | Drug | Vecuronium 0.1 mg/kg intubating dose |
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| Vecuronium 0.025 mg/kg maintenance dose | Drug | Vecuronium 0.025 mg/kg maintenance dose following the intubating dose |
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| Day of Surgery, after injection of study drug until return of first twitch to 25% |
| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| D008283 | Maintenance |
| D014673 | Vecuronium Bromide |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D005159 | Health Care Facilities Workforce and Services |
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