Remimazolam Phase II Cardiac Anesthesia Study

NCT ID: NCT01937767

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-02-19

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.

Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Propofol

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Sevoflurane

Intervention Type DRUG

Remifentanil

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

Rocuronium

Intervention Type DRUG

Remimazolam 6 mg/kg/hr

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

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Remifentanil

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

Rocuronium

Intervention Type DRUG

Remimazolam 12 mg/kg/hr

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

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Remifentanil

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

Rocuronium

Intervention Type DRUG

Interventions

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Remimazolam

Intervention Type DRUG

Propofol

Intervention Type DRUG

Sevoflurane

Intervention Type DRUG

Remifentanil

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

Rocuronium

Intervention Type DRUG

Other Intervention Names

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ByFavo, Aptimyda, CNS7056 Propofol-®Lipuro 10 mg/ml Sevofluran Baxter Ultiva (remifentanil hydrochloride) for Injection Fentanyl-Janssen Esmeron 10mg/ml solution for injection

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aptiv Solutions

INDUSTRY

Sponsor Role collaborator

Paion UK Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Probst, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center Leipzig - University Hospital

Locations

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Herzzentrum Leipzig GmbH

Leipzig, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2013-001113-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CNS7056-010

Identifier Type: -

Identifier Source: org_study_id

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