Remimazolam Phase II Cardiac Anesthesia Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01937767

Recruitment Status : Completed

First Posted : September 10, 2013

Last Update Posted : January 18, 2020

Sponsor:

Collaborator:

Aptiv Solutions

Information provided by (Responsible Party):

Paion UK Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
General Anesthesia	Drug: Remimazolam Drug: Propofol Drug: Sevoflurane Drug: Remifentanil Drug: Fentanyl Drug: Rocuronium	Phase 2

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	90 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
Official 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
Study Start Date :	August 2013
Actual Primary Completion Date :	February 2014
Actual Study Completion Date :	February 19, 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Propofol Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.	Drug: Propofol Other Name: Propofol-®Lipuro 10 mg/ml Drug: Sevoflurane Other Name: Sevofluran Baxter Drug: Remifentanil Other Name: Ultiva (remifentanil hydrochloride) for Injection Drug: Fentanyl Other Name: Fentanyl-Janssen Drug: Rocuronium Other Name: Esmeron 10mg/ml solution 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: Remimazolam Other Name: ByFavo, Aptimyda, CNS7056 Drug: Remifentanil Other Name: Ultiva (remifentanil hydrochloride) for Injection Drug: Fentanyl Other Name: Fentanyl-Janssen Drug: Rocuronium Other Name: Esmeron 10mg/ml solution for injection
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: Remimazolam Other Name: ByFavo, Aptimyda, CNS7056 Drug: Remifentanil Other Name: Ultiva (remifentanil hydrochloride) for Injection Drug: Fentanyl Other Name: Fentanyl-Janssen Drug: Rocuronium Other Name: Esmeron 10mg/ml solution for injection

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937767

Locations

Layout table for location information

Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289

Sponsors and Collaborators

Paion UK Ltd.

Aptiv Solutions

Investigators

Layout table for investigator information

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

More Information

Layout table for additonal information

Responsible Party:	Paion UK Ltd.
ClinicalTrials.gov Identifier:	NCT01937767
Other Study ID Numbers:	CNS7056-010 2013-001113-32 ( EudraCT Number )
First Posted:	September 10, 2013 Key Record Dates
Last Update Posted:	January 18, 2020
Last Verified:	January 2020

Additional relevant MeSH terms:

Layout table for MeSH terms

Fentanyl Remifentanil Propofol Sevoflurane Rocuronium Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics	Analgesics, Opioid Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Platelet Aggregation Inhibitors Anesthetics, Inhalation Neuromuscular Nondepolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents

To Top