Remimazolam Phase II Cardiac Anesthesia Study

Paion

Status and phase: Completed; Phase 2

Conditions: General Anesthesia

Treatments: Drug: Sevoflurane; Drug: Propofol; Drug: Remimazolam; Drug: Fentanyl; Drug: Rocuronium; Drug: Remifentanil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01937767

CNS7056-010

2013-001113-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Propofol

Active Comparator group

Description:

Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.

Treatment:

Drug: Remifentanil

Drug: Rocuronium

Drug: Fentanyl

Drug: Propofol

Drug: Sevoflurane

Remimazolam 6 mg/kg/hr

Experimental group

Description:

Induction: Remimazolam 6 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.

Treatment:

Drug: Remifentanil

Drug: Rocuronium

Drug: Fentanyl

Drug: Remimazolam

Remimazolam 12 mg/kg/hr

Experimental group

Description:

Induction: Remimazolam 12 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.

Treatment:

Drug: Remifentanil

Drug: Rocuronium

Drug: Fentanyl

Drug: Remimazolam