Remimazolam Phase II Cardiac Anesthesia Study

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01937767

Enrollment

Registered

2013-09-10

Start date

2013-08-31

Completion date

2014-02-19

Last updated

2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

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.

Interventions

DRUGRemimazolam

DRUGPropofol

DRUGSevoflurane

DRUGRemifentanil

DRUGFentanyl

DRUGRocuronium

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients with successful anesthesia	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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026