Remimazolam Phase II Cardiac Anesthesia Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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General Anesthesia

Intervention / Treatment
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* Drug: Remimazolam
* Drug: Propofol
* Drug: Sevoflurane
* Drug: Remifentanil
* Drug: Fentanyl
* Drug: Rocuronium


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil. | Drug: Propofol<br> <br> * Other names: Propofol-®Lipuro 10 mg/ml;Drug: Sevoflurane<br> <br> * Other names: Sevofluran Baxter;Drug: Remifentanil<br> <br> * Other names: Ultiva (remifentanil hydrochloride) for Injection;Drug: Fentanyl<br> <br> * Other names: Fentanyl-Janssen;Drug: Rocuronium<br> <br> * Other names: Esmeron 10mg/ml solution for injection;|
| Experimental: Remimazolam 6 mg/kg/hr<br>Induction: Remimazolam 6 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil. | Drug: Remimazolam<br> <br> * Other names: ByFavo, Aptimyda, CNS7056;Drug: Remifentanil<br> <br> * Other names: Ultiva (remifentanil hydrochloride) for Injection;Drug: Fentanyl<br> <br> * Other names: Fentanyl-Janssen;Drug: Rocuronium<br> <br> * Other names: Esmeron 10mg/ml solution for injection;|
| Experimental: Remimazolam 12 mg/kg/hr<br>Induction: Remimazolam 12 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil. | Drug: Remimazolam<br> <br> * Other names: ByFavo, Aptimyda, CNS7056;Drug: Remifentanil<br> <br> * Other names: Ultiva (remifentanil hydrochloride) for Injection;Drug: Fentanyl<br> <br> * Other names: Fentanyl-Janssen;Drug: Rocuronium<br> <br> * Other names: Esmeron 10mg/ml solution for injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with successful anesthesia | 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. | Between the start of study medication and the end of the surgical procedure (up to approx 12 hours) |