Remimazolam Phase II Cardiac Anesthesia Study

January 15, 2020 updated by: Paion UK Ltd.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04289
        • Herzzentrum Leipzig GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Propofol
Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.
Drug: Fentanyl
Other Names:
  • Fentanyl-Janssen
Drug: Propofol
Other Names:
  • Propofol-®Lipuro 10 mg/ml
Drug: Rocuronium
Other Names:
  • Esmeron 10mg/ml solution for injection
Drug: Sevoflurane
Other Names:
  • Sevofluran Baxter
Drug: Remifentanil
Other Names:
  • Ultiva (remifentanil hydrochloride) for Injection
EXPERIMENTAL: 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.
Drug: Fentanyl
Other Names:
  • Fentanyl-Janssen
Drug: Rocuronium
Other Names:
  • Esmeron 10mg/ml solution for injection
Drug: Remifentanil
Other Names:
  • Ultiva (remifentanil hydrochloride) for Injection
Drug: Remimazolam
Other Names:
  • ByFavo, Aptimyda, CNS7056
EXPERIMENTAL: 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.
Drug: Fentanyl
Other Names:
  • Fentanyl-Janssen
Drug: Rocuronium
Other Names:
  • Esmeron 10mg/ml solution for injection
Drug: Remifentanil
Other Names:
  • Ultiva (remifentanil hydrochloride) for Injection
Drug: Remimazolam
Other Names:
  • ByFavo, Aptimyda, CNS7056

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with successful anesthesia
Time Frame: 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.
Between the start of study medication and the end of the surgical procedure (up to approx 12 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paion UK Ltd.

Collaborators

Aptiv Solutions

Investigators

  • Principal Investigator: Stefan Probst, MD, Heart Center Leipzig - University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

February 19, 2014

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (ESTIMATE)

September 10, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 15, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNS7056-010
  • 2013-001113-32 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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