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Remimazolam Phase II Cardiac Anesthesia Study

P

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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