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CLINICAL TRIALS PROFILE FOR ROCURONIUM BROMIDE

Clinical Trials for Rocuronium Bromide

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Trial ID	Title	Status	Sponsor	Phase	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	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	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).
NCT00535743	Dose-Finding Trial With Sugammadex at 3 and 15 Minutes After 1.0 and 1.2 mg/kg Rocuronium Bromide in Subjects of ASA Class 1-3 (19.4.206)(P05944)	Completed	Merck Sharp & Dohme Corp.	Phase 2	The objective of the trial was to explore the dose-response relation of Org 25969 given as a reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in subjects of ASA 1 to 3, and to evaluate the safety of single doses of Org 25969 administered to subjects of ASA 1 to 3.
NCT00656799	Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773)	Completed	Merck Sharp & Dohme Corp.	Phase 3	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	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.
NCT00724932	Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)	Completed	Merck Sharp & Dohme Corp.	Phase 3	The current trial was designed to demonstrate faster recovery from a neuromuscular blockade (NMB) induced by rocuronium after reversal at 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 sugammadex compared to 50 µg.kg-1 neostigmine at reappearance of second twitch (T2) in participants undergoing laparoscopic cholecystectomy or appendectomy under propofol anesthesia, to compare safety and to evaluate operating room and Post Anesthetic Care Unit (PACU) length of stay.
NCT01111227	Inflammatory Cytokines Profile in Individuals Subjected to Surgical Procedures Using Propofol or Isoflurane	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	The aim of this study is to assess the profile of cytokines IL-1beta, IL-6, IL-8, IL-10, IL-12 and TNF-alpha under inhalation anesthesia with isoflurane and intravenous anesthesia with propofol in healthy patients subjected to minimally invasive elective surgeries.
Trial ID	Title	Status	Sponsor	Phase	Summary