CLINICAL TRIALS PROFILE FOR ROCURONIUM BROMIDE
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All Clinical Trials for Rocuronium Bromide
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00124722 ↗ | A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia | Completed | Merck Sharp & Dohme Corp. | Phase 3 | 2004-12-01 | 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. |
| NCT00124735 ↗ | A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | 2004-10-01 | The primary purpose of this study is to determine the dose requirements of rocuronium bromide when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) and when administered by either continuous infusion or bolus doses for maintenance of muscle relaxation 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). |
| NCT00421148 ↗ | Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | 2005-05-30 | The purpose of this study is: - to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616) given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult participants - to explore the pharmacokinetics (PK) of sugammadex in pediatric and adult participants, and to evaluate the safety of sugammadex in pediatric and adult participants. |
| NCT00535743 ↗ | Dose-Finding Trial With Sugammadex Administered at 3 and 15 Minutes After 1.0 and 1.2 mg/kg Rocuronium Bromide in Participants of ASA Class 1-3 (P05944; MK-8616-024) | Completed | Merck Sharp & Dohme Corp. | Phase 2 | 2004-03-04 | The objective of this trial was to explore the dose-response relation of sugammadex (Org 25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant), class 2 (participant with mild systemic disease), or class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating). |
| NCT00559468 ↗ | Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | 2006-12-07 | The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between participants receiving maintenance anesthesia using propofol and participants receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in participants after continuous infusion of rocuronium and before the administration of sugammadex, under either propofol or sevoflurane anesthesia. |
| NCT00656799 ↗ | Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | 2008-04-01 | The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment. |
| NCT00675792 ↗ | Comparison of Sugammadex Administered at 1-2 Post Tetanic Counts (PTCs) or Better With Neostigmine Administered as Per Standard of Care to Reverse Rocuronium-Induced Neuromuscular Blockade in Adults Undergoing Elective Open Abdominal Procedure (19.4 | Completed | Merck Sharp & Dohme Corp. | Phase 3 | 2008-05-01 | The primary purpose of this study is to compare the incidence of residual neuromuscular blockade at the time of tracheal extubation after reversal of rocuronium bromide-induced neuromuscular blockade by 4 mg/kg sugammadex with that of 50 µg/kg neostigmine. Residual neuromuscular blockade is defined as the fourth twitch to first twitch (T4/T1) ratio of < 0.90. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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