Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rocuronium · 2 trials · 2 indications
Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).
Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).
Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.
| Arm | Type | Description |
|---|---|---|
| Rocuronium - Sugammadex | ACTIVE_COMPARATOR | Rocuronium - Sugammadex 4.0 mg/kg |
| Succinylcholine | ACTIVE_COMPARATOR | Succinylcholine 1.0 mg/kg |
| Sugammadex | EXPERIMENTAL | 4.0 mg.kg-1 sugammadex at 1-2 PTC |
| Neostigmine | EXPERIMENTAL | 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2 |
| Name | Type | Description |
|---|---|---|
| rocuronium | DRUG | A single bolus intubation dose of 0.6 mg/kg rocuronium will be administered following induction of anesthesia and if required, single bolus dose(s) of 0.15 mg/kg rocuronium will be administered to maintain the neuromuscular block. |
| sugammadex | DRUG | At the end of the surgical procedure at a target depth of neuromuscular blockade of at least 1-2 Post-Tetanic Count (PTC), 4.0 mg/kg of sugammadex will be administered. |
| succinylcholine | DRUG | A single bolus intubation dose of 1.0 mg/kg succinylcholine will be administered following induction of anesthesia and the subject is allowed to recover spontaneously from the neuromuscular blockade. |
| Neostigmine | DRUG | After the last dose of rocuronium has been administered, participants will receive, according to the randomization, 50 μg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2. |
| Atropine | DRUG | After the last dose of rocuronium has been administered, participants will receive, according to randomization, 10 μg.kg-1 atropine (with neostigmine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2. |
Inclusion Criteria: * Male or female subjects \>=18 years of age; * ASA Class 1-3; * Subjects with a Body Mass Index (BMI) of \< 35 kg/m\^2 ; * Subjects scheduled to undergo an elective short procedure with general anesthesia requiring neuromuscular relaxation and endotracheal intubation in outpati...
Rocuronium is a small molecule used for general anesthesia and neuromuscular blockade. It is being studied in Phase 3 clinical trials for these indications. The drug is administered to produce muscle relaxation during surgical procedures, as part of the anesthesia regimen.
Rocuronium is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety for use in anesthesia and neuromuscular blockade.
Rocuronium is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trials are completed, and the drug is being evaluated for use in general anesthesia and neuromuscular blockade.
Rocuronium has been studied in three completed Phase 3 trials: NCT00724932, comparing it with neostigmine during laparoscopic cholecystectomy or appendectomy; NCT00751179, comparing rocuronium plus sugammadex versus succinylcholine alone; and NCT00970762, comparing rocuronium with vecuronium. These trials involved patients undergoing surgical procedures.
Rocuronium is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. The completed trials have evaluated its use in anesthesia and neuromuscular blockade, but the drug has not yet received regulatory approval for marketing.