Remimazolam Phase II Cardiac Anesthesia Study

Phase 2CompletedNCT01937767

Paion UK Ltd.90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

General Anesthesia

Interventions

RemimazolamDRUG

PropofolDRUG

SevofluraneDRUG

RemifentanilDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Herzzentrum Leipzig GmbH

Leipzig, Germany

Outcomes

Primary Outcomes

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.

Time frame: Between the start of study medication and the end of the surgical procedure (up to approx 12 hours)

Data from ClinicalTrials.gov

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