Inclusion criteria:
In order to be eligible to participate in this trial, an individual must meet
all of the following criteria:
• Male or female ASA III / IV patients, at least 18 years old, scheduled
for an elective surgical procedure of a minimum duration of
approximately 90 minutes under GA and planned to be extubated
immediately post-operatively
• Total intravenous GA with the requirement for mechanical ventilation
via endotracheal tube and necessary invasive BP monitoring either due
to severity of illness, severity of concomitant diseases, type of surgery or
decisions of the anaesthesia staff.
• Patients scheduled to stay in the hospital long enough after the
surgical procedure to perform all trial follow-up procedures (~1 day)For female patients of childbearing potential: Negative results of 2
pregnancy tests, the first test taken at the start of Screening and
the second test taken shortly before the start of the administration
of the IMP as well as consent to use highly effective birth control
from the last menstrual cycle prior to the start of the IMP until the
end of the trial follow-up procedures. Highly effective methods of
birth control include:
o Combined (estrogen and progestogen containing) hormonal
contraception associated with inhibition of ovulation: Oral / intravaginal / transdermal
o Progestogen-only hormonal contraception associated with
inhibition of ovulation: Oral / injectable / implantable
o Intrauterine device (IUD)
o Intrauterine hormone–releasing system (IUS)
o Bilateral tubal occlusion
o Vasectomised partner (provided that the partner is the sole
sexual partner of the female patient of childbearing potential
and that the vasectomised partner has received medical
assessment of the surgical success).
o Sexual abstinence (this method is not acceptable in
Switzerland). Women who had their last menstruation at least two years
ago or who underwent surgical interventions (surgical birth control,
bilateral oophorectomy, hysterectomy, etc.) are regarded as having no
childbearing potential.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 358
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 154
Exclusion criteria:
An individual who meets any of the following criteria will be excluded
from participation in this trial:
- Patients scheduled for spinal anaesthesia, epidural anaesthesia
(central neuroaxial anaesthesia) or regional anaesthesia. The placement
of a local anaesthetic drug (up to 5 mL) to verify
correct positioning to achieve post-operative analgesia and the regional
administration of local anaesthetic for post-operative analgesia after
wound closure ( after the last skin suture) is accepted.
- Patients undergoing transplant surgery, cardiac surgery, intracranial
neurosurgery, emergency surgery, or any surgical procedure with the
need for or scheduled for post-operative ventilator support
- Patients undergoing surgical procedures that require keeping the BP at
a high level, e.g. surgical procedures in beach chair position
- Patients with severe hypertension, i.e., one baseline result of systolic
BP 200 mmHg or more and / or diastolic BP of 120 mmHg or more.
Baseline is defined as the time after signature of ICF and before arrival
in the OR suite.
- Patients with total bilirubin of =3.0 mg/dL or =3 times increase in
aspartate aminotransferase or alanine aminotransferase as per the
reference range, in laboratory tests which must be checked within
the 7 days prior to start of IMP, or any other laboratory results that
make the patient unsuitable for the trial.
- Patients with end-stage renal disease requiring scheduled dialysis
- Patients with known anaphylactic reactions to benzodiazepines,
propofol, opioid analgesics, non-steroidal anti-inflammatory drugs
(NSAIDs), dextran, neuromuscular blocking agents, flumazenil,
naloxone, or other anaesthetic agents, or a medical condition such that
these agents are contraindicated (according to local label) patients with allergy/hypersensitivity to bovine lactose, dextrane or any other excipient in the remimazolam product
- Presence of acute alcoholic or illicit drug intoxication, shock or coma
state
- Known current dependency on or regular use of central nervous system depressant
drugs or alcohol
- Patients with gastroparesis or delayed gastric emptying, gastric reflux
or any other increased risk for gastric aspiration
- Patients with an anticipated (small mouth opening, impaired neck
movement, goitre, head and neck tumours or any other anatomical
reason) or known airways difficult , known difficulties in airway
maintenance or mask ventilation.
- Patients in whom NCT may not provide results due to organic defect of
the brain or forehead, or any neurologic disease interfering with the EEG
monitoring
- Patients on treatment with valproate
- Any pregnant or breast-feeding patient
- Patients who participated in any clinical trial within 30 days or 5
times the half-life of the drug under investigation in any other clinical
trial, whichever is longer, prior to the beginning of administration of
the IMP. Exception: Non-interventional trials as defined in the
European Clinical Trials Directive 2001/20/EC: A trial where the
medicinal product(s) is (are) prescribed in the usual manner in
accordance with the terms of the marketing authorisation. The
assignment of the patient to a particular therapeutic strategy is not
decided in advance by a trial protocol but falls within current
practice and the prescription of the medicine is clearly separated
from the decision to include the patient in the study. No additional
diagnostic or monitoring procedures shall be applied to the patients
and epidemiological methods sh
