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Rocuronium/kg intubating dose

Phase 3

Anesthesia | Small molecule | Pain |Merck & Company, Inc.|Last Updated: Apr 17, 2015

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

Rocuronium/kg intubating dose · 1 trial · 1 indication

Phase 3 1
NCT00970762Comparative Study of Rocuronium With Vecuronium (Study 71101)(COMPLETED)Anesthesia
COMPLETED90 Analytics
PHASE3COMPLETED
Comparative Study of Rocuronium With Vecuronium (Study 71101)(COMPLETED)
Anesthesia
NCT0097076290
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Study Endpoints

Primary Endpoints

Onset time of intubating dose. DESCRIPTION: The time interval between the completion of injection of the study drug (rocuronium or vecuronium) and the maximal depression of first twitch--measured via TOF Watch Sx(R)-- was defined as the onset time.
Day of Surgery, after injection of study drug until maximal depression of first twitch achieved

Secondary Endpoints

Number of subjects who achieved maximal block >=90% after the intubating dose. DESCRIPTION: Reaching a 90% depression of first twitch--measured via TOF Watch Sx(R)--was defined as achieving 90% block
Day of Surgery, after injection of study drug until maximal depression of first twice achieved
Clinical duration after first maintenance dose. DESCRIPTION: The time interval between the completion of injection of study drug and return of first twitch to 25%(as measured by TOF Watch Sx(R)) was defined as the clinical duration.
Day of Surgery, after injection of study drug until return of first twitch to 25%
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Rocuronium 0.6 INT, 0.1 MNTEXPERIMENTALParticipants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.
Rocuronium 0.6 INT, 0.15 MNTEXPERIMENTALParticipants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.
Rocuronium 0.6 INT, 0.2 MNTEXPERIMENTALParticipants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.
Rocuronium 0.9 INT, 0.1 MNTEXPERIMENTALParticipants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.
Rocuronium 0.9 INT, 0.15 MNTEXPERIMENTALParticipants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.
Rocuronium 0.9 INT, 0.2 MNTEXPERIMENTALParticipants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.
Vecuronium 0.1 INT, 0.025 MNTACTIVE_COMPARATORParticipants in this group received a 0.1 mg/kg intubating dose of vecuronium followed by 0.025 mg/kg maintenance dose of vecuronium.

Interventions

NameTypeDescription
Rocuronium 0.6 mg/kg intubating doseDRUGRocuronium 0.6 mg/kg intubating dose
Rocuronium 0.9 mg/kg intubating doseDRUG0.9 mg/kg intubating dose of rocuronium
Rocuronium 0.1 mg/kg maintenance doseDRUGRocuronium 0.1 mg/kg maintenance dose following the intubating dose.
Rocuronium 0.15 mg/kg maintenance doseDRUGRocuronium 0.15 mg/kg maintenance dose following the intubating dose
Rocuronium 0.2 mg/kg maintenanceDRUGRocuronium 0.2 mg/kg maintenance dose following the intubating dose
Vecuronium 0.1 mg/kg intubating doseDRUGVecuronium 0.1 mg/kg intubating dose
Vecuronium 0.025 mg/kg maintenance doseDRUGVecuronium 0.025 mg/kg maintenance dose following the intubating dose
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Eligibility Criteria

Age Range20 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion criteria: * at least 20 but under 65 years of age * American Society of Anesthesiologists (ASA) Class 1, 2 or 3 for general elective surgery * not considered to be pregnant * scheduled for elective surgery under sevoflurane or propofol anesthesia with an anticipated duration of about 1.5-...

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Competitive Landscape -Anesthesia and Sedation 4 trials (matched to "Anesthesia")

CompanyTickerTrialsLead PhaseDrugs
Masimo CorporationMASI1PHASE1Diprivan, Astra-Zeneca
Cardinal Health, Inc.CAH1 - Undisclosed
Medtronic PlcMDT1N/AUndisclosed
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Frequently asked questions about Rocuronium/kg intubating dose

What is Rocuronium used for?

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.

Who makes Rocuronium?

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.

What phase is Rocuronium in?

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.

What clinical trials is Rocuronium in?

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.

Is Rocuronium FDA approved?

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.