EUCTR2018-000174-29-IT进行中（未招募）1 期
Phase III confirmatory efficacy and safety trial of remimazolam (CNS7056)compared with propofol for intravenous anaesthesia during electivesurgery - CNS7056-022
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 512
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •- 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
- •- 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
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研究者
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