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Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia During Elective Surgery

NCT03661489 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 469

Last updated 2020-05-28

No results posted yet for this study

Summary

A phase III confirmatory trial evaluating the efficacy and safety of remimazolam (CNS7056) compared to propofol for intravenous anesthesia during elective surgery in ASA Class III/IV patients.

Conditions

  • Anesthesia, Intravenous

Interventions

DRUG

Remimazolam

For induction and maintenance of general anesthesia

DRUG

Propofol

For induction and maintenance of general anesthesia

Sponsors & Collaborators

  • ORION Clinical Services

    collaborator INDUSTRY

  • Simbec Research

    collaborator INDUSTRY

  • Creative Clinical Research GmbH

    collaborator UNKNOWN

  • Paion UK Ltd.

    lead INDUSTRY

Principal Investigators

  • Jörg Fechner, Prof. Dr. · University Erlangen-Nürnberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2020-04-02
Completion
2020-04-02

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03661489 on ClinicalTrials.gov