NCT01937767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2014

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

August 29, 2013

Last Update Submit

January 15, 2020

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Study Arms (3)

Propofol

ACTIVE COMPARATOR

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

Drug: PropofolDrug: SevofluraneDrug: RemifentanilDrug: FentanylDrug: Rocuronium

Remimazolam 6 mg/kg/hr

EXPERIMENTAL

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

Drug: RemimazolamDrug: RemifentanilDrug: FentanylDrug: Rocuronium

Remimazolam 12 mg/kg/hr

EXPERIMENTAL

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

Drug: RemimazolamDrug: RemifentanilDrug: FentanylDrug: Rocuronium

Interventions

RemimazolamDRUG
Also known as: ByFavo, Aptimyda, CNS7056
Remimazolam 12 mg/kg/hrRemimazolam 6 mg/kg/hr
PropofolDRUG
Also known as: Propofol-®Lipuro 10 mg/ml
Propofol
SevofluraneDRUG
Also known as: Sevofluran Baxter
Propofol
RemifentanilDRUG
Also known as: Ultiva (remifentanil hydrochloride) for Injection
PropofolRemimazolam 12 mg/kg/hrRemimazolam 6 mg/kg/hr
FentanylDRUG
Also known as: Fentanyl-Janssen
PropofolRemimazolam 12 mg/kg/hrRemimazolam 6 mg/kg/hr
RocuroniumDRUG
Also known as: Esmeron 10mg/ml solution for injection
PropofolRemimazolam 12 mg/kg/hrRemimazolam 6 mg/kg/hr

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled for major elective cardiac surgery.
  • scheduled for mechanical ventilation via tracheal intubation.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

MeSH Terms

Interventions

remimazolamPropofolSevofluraneRemifentanilWW Domain-Containing OxidoreductaseFentanylRocuroniumSolutionsInjections

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsShort Chain Dehydrogenase-ReductasesNAD (+) and NADP (+) Dependent Alcohol OxidoreductasesAlcohol OxidoreductasesOxidoreductasesEnzymesEnzymes and CoenzymesTumor Suppressor ProteinsNeoplasm ProteinsProteinsAmino Acids, Peptides, and ProteinsAndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPharmaceutical PreparationsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Stefan Probst, MD

    Heart Center Leipzig - University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2013

First Posted

September 10, 2013

Study Start

August 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 19, 2014

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

DE(1)