Registrationsdatum der Studie
Einschluss der ersten teilnehmenden Person
Phase III confirmatory efficacy and safety trial of remimazolam (CNS7056) compared with propofol for intravenous anaesthesia during elective surgery
Interventional clinical trial of medicinal product
Design der Studie
Single blind: yes
Double blind: no
Parallel group: yes
Cross over: no
If controlled, specify comparator, Other Medicinial Product: yes
Number of treatment arms in the trial: 2
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no
Timepoint(s) of evaluation of this end point: During the maintenance phase of the GA;Primary end point(s): The primary efficacy endpoint (PEP) is the anaesthetic effect of remimazolam and propofol assessed as percent (%) of time of Narcotrend (NCT) Index =60 during the maintenance phase of the GA defined as the time between the first skin incision and the completion of the last skin suture;Secondary Objective: This is a confirmatory trial to establish superior haemodynamic stability associated with the use of remimazolam compared with propofol for the induction and maintenance of GA for the purpose of elective surgery.;Main Objective: This is a confirmatory trial to establish non-inferior efficacy of remimazolam compared with propofol for induction and maintenance of GA for the purpose of elective surgery.
Secondary end point(s): The key secondary endpoint (KSE) is haemodynamic instability defined as critical decrease(s) in mean arterial blood pressure (MAP) between start of IMP and 15 minutes after the 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.
The baseline MAP is calculated based on all blood pressure (BP) measurements that are taken after signing the informed consent form (ICF) and before arrival at the operation room (OR) suite.
This endpoint is a safety endpoint.
Other secondary endpoints for efficacy comprise
• Percentage of time of NCT index (NCI) =60 and =40 during the maintenance phase
• Percentage of time of NCI <40 during the maintenance phase
• Percentage of patients with NCI =60 and =40 during =90% of the maintenance phase
• Percentage of patients who were administered rescue sedative medication
• The occurrence of intra-operative awakening (explicit awareness)
• Time from start of IMP to first NCI =60
• Time from start of IMP to loss of palpebral reflex
• Time from start of IMP to loss of consciousness (LOC, i.e., modified observer’s assessment of alertness / sedation [MOAA/S] = 0)
• Time from stop of IMP to response to verbal command (MOAA/S =4)
• Time from stop of IMP to end of extubation
• Time from stop of IMP to orientation to time, place, person and situation
• Time from stop of IMP to Modified Aldrete Score = 10
• Investigator’s overall satisfaction with IMP;Timepoint(s) of evaluation of this end point: During the maintenance phase of the GA
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