CLINICAL TRIALS PROFILE FOR BRIDION
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All Clinical Trials for BRIDION
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00751179 ↗ | Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Participants Undergoing Short Surgical Procedures (19.4.319)(P05700 AM2)(COMPLETED) | Completed | Merck Sharp & Dohme Corp. | Phase 3 | 2008-11-01 | A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoing short surgical procedures in out-patient surgicenters. The primary objective was to evaluate changes in plasma potassium levels after treatment with rocuronium, sugammadex, or succinylcholine in adult subjects scheduled for short surgical procedures in out-patient surgicenters. |
| NCT00953550 ↗ | Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine | Completed | TrygFonden, Denmark | Phase 4 | 2009-09-01 | Rapid sequence intubation is used, when there is an elevated risk of aspiration to the lungs of stomach content. It is typically used in acute settings that require acute surgery or in prehospital settings, but also in specific risk patients requiring elective surgery. The reason for conducting rapid sequence intubation is to minimize the risk of pulmonary aspiration and at the same time achieve a fast induction of anaesthesia and intubation. Rapid sequence intubation is a procedure with a high risk of complications in itself. The time period from induction of anaesthesia to intubation is particularly risky, because the patient is apneic. This study addresses this problem by investigating, how quickly spontaneous respiration can be reestablished after a rapid sequence intubation when using Rocuronium-Sugammadex compared to Succinylcholine. This is a pilot protocol that is intended to establish a sample size for the full protocol. Study hypothesis: The time from correct tube placement to spontaneous respiration is shorter when using Rocuronium/Sugammadex compared to Succinylcholine. |
| NCT00953550 ↗ | Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine | Completed | Rigshospitalet, Denmark | Phase 4 | 2009-09-01 | Rapid sequence intubation is used, when there is an elevated risk of aspiration to the lungs of stomach content. It is typically used in acute settings that require acute surgery or in prehospital settings, but also in specific risk patients requiring elective surgery. The reason for conducting rapid sequence intubation is to minimize the risk of pulmonary aspiration and at the same time achieve a fast induction of anaesthesia and intubation. Rapid sequence intubation is a procedure with a high risk of complications in itself. The time period from induction of anaesthesia to intubation is particularly risky, because the patient is apneic. This study addresses this problem by investigating, how quickly spontaneous respiration can be reestablished after a rapid sequence intubation when using Rocuronium-Sugammadex compared to Succinylcholine. This is a pilot protocol that is intended to establish a sample size for the full protocol. Study hypothesis: The time from correct tube placement to spontaneous respiration is shorter when using Rocuronium/Sugammadex compared to Succinylcholine. |
| NCT01213264 ↗ | Observational Study to Evaluate the Current Neuromuscular Monitoring Practice Used After Different Types of Surgery, for Which Neuromuscular Blocking Agents Were Used, With or Without Blocking Reversal (P06556) | Completed | Merck Sharp & Dohme Corp. | 2010-09-01 | The intent of this observational study is to collect prospective data regarding neuromuscular monitoring practices and extubation standards (Train-Of-Four [TOF] value) during surgery, in countries of Central and Eastern Europe, Middle East and Africa (CEE/EEMEA countries). Secondarily the study will observe, for which surgical procedures neuromuscular blocking agents (NMBAs), and reversal agents to such, are used. This study is a non-interventional clinical trial, and administration of NMBAs, and respective reversal agents, (as well as all drugs used during anesthesia) will be done in accordance with routine anesthesiology practice, and labeling guidelines. Neuromuscular transmission will be monitored according to routine anesthesiology practice by means of acceleromyography. The assignment of the participant to a particular therapeutic strategy is not decided in advance by a trial protocol, but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. | |
| NCT01424488 ↗ | Sugammadex Efficacy and Safety for Reversal of Pipecuronium-induced Neuromuscular Blockade | Unknown status | Central Clinical Hospital #1 of LLC Russian Railways | Phase 4 | 2011-09-01 | Primary objectives: 1. to investigate the efficacy of sugammadex in dose of 4 mg/kg administered at reappearance of T2 for reversal of pipecuronium-induced neuromuscular blockade in subjects undergoing abdominal surgery under general anesthesia 2. to evaluate the safety and tolerability of a single dose of 4 mg/kg sugammadex administered at reappearance of T2 for reversal of pipecuronium-induced neuromuscular blockade Secondary objectives: 1. to evaluate the time from the start of sugammadex or placebo administration to the time of extubation and to the time of recovery of TOF ratio to ≥ 0.9 Exploratory objectives: 1. to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay after the end of surgery in subjects with pipecuronium induced neuromuscular blockade reversed by 4.0 mg.kg-1 sugammadex compared to placebo (saline) 2. compare the number of patients extubated in the OR after the reversal by sugammadex or placebo, evaluate the TOF ratio at the time of extubation Clinical hypothesis: 1. Sugammadex has to be effective and well tolerated for reversal of pipecuronium-induced blockade |
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