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Completed

NCT Number: NCT01937767

Remimazolam Phase II Cardiac Anesthesia Study

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.

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Key information

Conditions

General Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Remimazolam

Drug

Other names: ByFavo, Aptimyda, CNS7056

Propofol

Drug

Other names: Propofol-®Lipuro 10 mg/ml

Sevoflurane

Drug

Other names: Sevofluran Baxter

Remifentanil

Drug

Other names: Ultiva (remifentanil hydrochloride) for Injection

Fentanyl

Drug

Other names: Fentanyl-Janssen

Rocuronium

Drug

Other names: Esmeron 10mg/ml solution for injection

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Paion UK Ltd.

Industry

Collaborators

  • Aptiv Solutions

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 10, 2013
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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