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Remimazolam Phase II Cardiac Anesthesia Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01937767
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Aptiv Solutions
Information provided by (Responsible Party):
Paion UK Ltd.

Tracking Information
First Submitted Date  ICMJE August 29, 2013
First Posted Date  ICMJE September 10, 2013
Last Update Posted Date January 18, 2020
Study Start Date  ICMJE August 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2020)
Proportion of patients with successful anesthesia [ Time Frame: Between the start of study medication and the end of the surgical procedure (up to approx 12 hours) ]
Successful anesthesia was defined as no use of rescue sedative medication between start of the study medication and end of the surgical procedure completion of last skin suture.
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
Proportion of patients with successful anesthesia [ Time Frame: Between the start of study medication and the end of the surgical procedure (up to approx 12 hours) ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remimazolam Phase II Cardiac Anesthesia Study
Official Title  ICMJE A Randomized, Single-blind Phase II Study Evaluating the Efficacy, Safety and Pharmacokinetics of Remimazolam in General Anesthesia in Adult Patients Undergoing Cardiac Surgery, Including Follow-up Sedation in the PACU/ICU
Brief Summary This phase II study in patients undergoing elective cardiac surgery will evaluate the efficacy, safety, and pharmacokinetics of remimazolam, compared with propofol and sevoflurane, during the induction and maintenance of general anesthesia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE General Anesthesia
Intervention  ICMJE
  • Drug: Remimazolam
    Other Name: ByFavo, Aptimyda, CNS7056
  • Drug: Propofol
    Other Name: Propofol-®Lipuro 10 mg/ml
  • Drug: Sevoflurane
    Other Name: Sevofluran Baxter
  • Drug: Remifentanil
    Other Name: Ultiva (remifentanil hydrochloride) for Injection
  • Drug: Fentanyl
    Other Name: Fentanyl-Janssen
  • Drug: Rocuronium
    Other Name: Esmeron 10mg/ml solution for injection
Study Arms  ICMJE
  • Active Comparator: Propofol
    Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.
    Interventions:
    • Drug: Propofol
    • Drug: Sevoflurane
    • Drug: Remifentanil
    • Drug: Fentanyl
    • Drug: Rocuronium
  • Experimental: Remimazolam 6 mg/kg/hr
    Induction: Remimazolam 6 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
    Interventions:
    • Drug: Remimazolam
    • Drug: Remifentanil
    • Drug: Fentanyl
    • Drug: Rocuronium
  • Experimental: Remimazolam 12 mg/kg/hr
    Induction: Remimazolam 12 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
    Interventions:
    • Drug: Remimazolam
    • Drug: Remifentanil
    • Drug: Fentanyl
    • Drug: Rocuronium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2013)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 19, 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • scheduled for major elective cardiac surgery.
  • scheduled for mechanical ventilation via tracheal intubation.

Exclusion Criteria:

  • thoraco-abdominal replacement of the aorta or other procedure expected to be accompanied by a massive hemorrhage (at least 15% of the circulating blood volume).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01937767
Other Study ID Numbers  ICMJE CNS7056-010
2013-001113-32 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paion UK Ltd.
Study Sponsor  ICMJE Paion UK Ltd.
Collaborators  ICMJE Aptiv Solutions
Investigators  ICMJE
Principal Investigator: Stefan Probst, MD Heart Center Leipzig - University Hospital
PRS Account Paion UK Ltd.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP