Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia During Elective Surgery
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03661489|
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : October 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia, Intravenous||Drug: Remimazolam Drug: Propofol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase III Confirmatory Efficacy and Safety Trial of Remimazolam (CNS7056) Compared With Propofol for Intravenous Anesthesia During Elective Surgery in ASA Class III/IV Patients|
|Actual Study Start Date :||July 24, 2018|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2020|
Experimental: Intravenous Remimazolam 50 mg
For induction of general anesthesia, remimazolam is co-administered with remifentanil for analgesia and with a muscle relaxant as necessary.
For maintenance of general anesthesia remimazolam is titrated to effect. Administration of boluses of remimazolam is allowed. Remifentanil is continued and/or titrated. Boluses of muscle relaxants are given throughout the surgical procedure as needed.
For induction and maintenance of general anesthesia
Active Comparator: Intravenous Propofol 2%
For induction of general anesthesia, propofol is co-administered with remifentanil for analgesia and with a muscle relaxant as necessary.
For maintenance of general anesthesia propofol is titrated to effect. Administration of boluses of propofol is allowed. Remifentanil is continued and/or titrated. Boluses of muscle relaxants are given throughout the surgical procedure as needed.
For induction and maintenance of general anesthesia
- Percentage (%) of time of Narcotrend Index (NCI) values ≤ 60 during maintenance phase of general anesthesia (defined as time between the first skin incision and the completion of the last skin suture) [ Time Frame: maintenance phase of general anesthesia (time between the first skin incision and the completion of the last skin suture) ]The primary efficacy endpoint (PEP) is the anesthetic effect of remimazolam and propofol assessed as percent (%) of time of NCI ≤60 during the maintenance phase of general anesthesia
- Number of events of critical decrease(s) in mean arterial blood pressure (MAP) [ Time Frame: From start of Investigational Medicinal Product (IMP) administration until 15 minutes after first skin incision ]
For this endpoint, each event from the following categories will be counted and summed up per patient:
- Incidence of MAP dropping below 65 mmHg for at least 1 minute duration
- Incidence of a MAP decrease of more than 20% below the calculated (mean) baseline MAP value for at least 1 minute duration
- Incidence of a MAP decrease of more than 30% below the calculated (mean) baseline MAP value for at least 1 minute duration
- Number of norepinephrine boluses (0.01 mg) required or, if an infusion is used to maintain MAP equal to or above 65 mmHg, then each time interval of 2 minutes duration of continuous norepinephrine infusion will be counted as one event.
- Percentage of time of NCI ≤60 and ≥40 during the maintenance phase [ Time Frame: During the maintenance phase of general anesthesia: from first skin incision to last skin suture ]Adherence to a pre-defined corridor to avoid sedation being too light or being too deep
- Time from start of IMP administration to loss of consciousness [ Time Frame: During induction of general anesthesia ]Loss of consciousness is defined as modified observer's assessment of alertness / sedation = 0
- Time from stop of IMP to end of extubation [ Time Frame: During recovery phase of general anesthesia ]Extubation is defined as the precise time (hh:mm) by when the tracheal tube used for the mechanical ventilation is removed
- Time from stop of IMP to Modified Aldrete Score = 10 [ Time Frame: During recovery phase of general anesthesia ]The time by when full recovery is reached defined as the time by when the Modified Aldrete Score is 10 for the first time
- Delirium assessed by the Nursing Delirium Screening Scale (Nu-DESC) [ Time Frame: During Screening, shortly before starting IMP (in the preparation period), in the Recovery Period and during Follow-up (up to 1 week after the end of the surgery) ]Any appearance of symptoms indicating delirium will be captured using the Nu-DESC
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): NCT03661489
|Contact: Trial Information||+49 email@example.com|
|University of Erlangen||Recruiting|
|Erlangen, Bavaria, Germany, 91054|
|Principal Investigator:||Jörg Fechner, Prof. Dr.||University Erlangen-Nürnberg|