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Remimazolam Phase II Cardiac Anesthesia Study

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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.

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.

Condition or disease Intervention/treatment Phase
General Anesthesia Drug: Remimazolam Drug: Propofol Drug: Sevoflurane Drug: Remifentanil Drug: Fentanyl Drug: Rocuronium Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 19, 2014

Arm Intervention/treatment
Active Comparator: Propofol
Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.
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

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.
Drug: Remimazolam
Other Name: ByFavo, Aptimyda, CNS7056

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

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.
Drug: Remimazolam
Other Name: ByFavo, Aptimyda, CNS7056

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937767


Locations
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Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
Sponsors and Collaborators
Paion UK Ltd.
Aptiv Solutions
Investigators
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Principal Investigator: Stefan Probst, MD Heart Center Leipzig - University Hospital
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Responsible Party: Paion UK Ltd.
ClinicalTrials.gov Identifier: NCT01937767    
Other Study ID Numbers: CNS7056-010
2013-001113-32 ( EudraCT Number )
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Fentanyl
Remifentanil
Propofol
Sevoflurane
Rocuronium
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents