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CompletedNCT00984633Updated May 12, 2015

Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 (Study P05976)(COMPLETED)

A Phase 3 interventional study of Rocuronium bromide (Org 9426) and Rocuronium bromide (Org 9426) in Muscle Relaxation, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2015-05-12.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 64 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy, pharmacokinetics, and safety of Org 9426 in maintenance of muscle relaxation in adult subjects undergoing general elective surgery.

02

Conditions studied

  • Muscle Relaxation

Keywords

  • Neuromuscular Blocking Agents
03

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects at least 20 but under 65 years of age.
  • Subjects of asa class 1, 2 or 3 for general elective surgery.
  • Subjects who are not considered to be pregnant.
  • Subjects scheduled for elective surgery under sevoflurane or propofol anesthesia, with anticipated duration of surgery of about 1.5-3 hours.
  • Subjects with normal laboratory values for serum electrolytes (Na+, K+, Cl-), BUN, creatinine, total bilirubin, ALP, ALAT and ASAT as judged by the investigator or the sub-investigator.
  • Subjects who received an explanation of the trial and agreed informed consent in writing to participate in the trial in advance.

Exclusion criteria

Exclusion Criteria:

  • Subjects with renal dysfunction as a complication or in the history.
  • Subjects with serum creatinine level greater than 1.6 mg/dL.
  • Subjects with severe hepatic dysfunction as a complication or in the history.
  • Subjects with known significant metabolic or neuromuscular disorders.
  • Subjects with showing dyspnea, airway obstruction or bronchial asthma.
  • Subjects with a history of hypersensitivity to pancuronium bromide, vecuronium bromide or bromine.
  • Subjects with atopic diseases.
  • Subjects who have developed any systemic allergic symptoms.
  • Subjects receiving antihistamines and antiallergic agents for 1 month or more.
  • Subjects receiving any of the following drugs known to affect on the action of neuromuscular blocking agents on surgery day: calcium antagonists; anticonvulsants; aminoglycoside antibiotics; polypeptide antibiotics; or metronidazole.
  • Subjects under hypothermic anesthesia.
  • Subjects who participated as research subjects in another trial within the last 6 months or is now participating in other trials.
  • Other subjects judged to be ineligible as subjects in this trial by the discretion of the investigator or the sub-investigator.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    0.6 mg/kg intubation dose + sevoflurane

    Drug: Rocuronium bromide (Org 9426) · Drug: Sevoflurane

  • Experimental
    0.9 mg/kg intubation dose + sevoflurane

    Drug: Rocuronium bromide (Org 9426) · Drug: Sevoflurane

  • Experimental
    0.6 mg/kg intubation dose + propofol

    Drug: Rocuronium bromide (Org 9426) · Drug: Propofol

  • Experimental
    0.9 mg/kg intubation dose + propofol

    Drug: Rocuronium bromide (Org 9426) · Drug: Propofol

Interventions

06

What researchers measure

Primary outcomes

  1. Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation

    Time frame: Time from intubating dose to bolus maintenance dose

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00984633
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Sep 25, 2009
Start date
Jun 2003
Primary completion
Dec 2003
Completion
Dec 2003
Last update
May 12, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Sevoflurane · Propofol

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