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
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Condition or disease | Intervention/treatment | Phase |
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General Anesthesia | Drug: Remimazolam Drug: Propofol Drug: Sevoflurane Drug: Remifentanil Drug: Fentanyl Drug: Rocuronium | Phase 2 |
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 |
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Active Comparator: Propofol
Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.
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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.
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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.
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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 |
- 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 |
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).

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
Germany | |
Herzzentrum Leipzig GmbH | |
Leipzig, Germany, 04289 |
Principal Investigator: | Stefan Probst, MD | Heart Center Leipzig - University Hospital |
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 |
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 |