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| ID | Type | Description | Link |
|---|---|---|---|
| 021049 |
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The primary purpose of this study is to evaluate the time course of muscle relaxation after administration of three different single intravenous bolus doses of rocuronium bromide for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) in term neonates (birth to <28 days old), infants (28 days to <=3 months) and toddlers (>3 months to <=2 years), children (2 years to less than or equal to 11 years of age), and adolescents (>11 years to less than or equal to 17 years of age).
Subjects in each of the age groups will be randomized to one of 3 Zemuron® doses: 0.45 mg/kg, 0.6 mg/kg, or 1.0 mg/kg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.45 mg/kg Zemuron | Experimental | 0.45 mg/kg Zemuron |
|
| 0.6 mg/kg Zemuron | Active Comparator | 0.6 mg/kg Zemuron |
|
| 1.0 mg/kg Zemuron | Experimental | 1.0 mg/kg Zemuron |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium bromide (Zemuron) | Drug | A single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to reappearance of T3 (time from end-administration of Zemuron to reappearance of the third twitch of a TOF stimulation) | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Onset time, maximum block, time to reappearance of T1, Recovery to TOF 0.7, 0.8 and 0.9 and intubation score | during and after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Tirotta CF, Brandom B, Siddiqui MS, Ehlers M, Betzel J, Chen J-Y, De Bie J, Blobner M. Time Course of Rocuronium-Induced Neuromuscular Blockade in Pediatric Patients: A Phase III, Randomized, Dose-Response Study. J Anesthe Clin Res. 2012;3:189. |
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| Rocuronium bromide (Zemuron) | Drug | A single IV Zemuron bolus dose of 0.6 mg/kg prior to intubation. |
|
|
| Rocuronium bromide (Zemuron) | Drug | A single IV Zemuron bolus dose of 1.0 mg/kg prior to intubation. |
|
|
| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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