Phase III confirmatory efficacy and safety trial of remimazolam (CNS7056) compared with propofol for intravenous anaesthesia during elective surgery

PAION UK Limited0 个研究点目标入组 500 人开始时间: 2018年5月23日最近更新: 2020年11月9日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: PAION UK Limited
入组人数: 500

研究概览入排标准研究者记录与标识符相似试验

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
•- 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
•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 350
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

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 peridural catheter with a test dose application 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 postoperative analgesia after wound closure is accepted.
•- Patients undergoing transplant surgery, cardiac surgery, or intracranial neurosurgery, patients which have to be in prone position for surgery, 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 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, dextran or any other excipient in the remimazolam product.
•- Presence of acute alcoholic or illicit drug intoxication, shock or coma state
•- Known current dependency on 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 difficulties, 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 s

研究者

发起方

PAION UK Limited

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