ISRCTN12741394进行中（未招募）未知
A randomised active-controlled study to compare efficacy and safety of inhaled isoflurane delivered by the AnaConDa-S (anaesthetic conserving device) to intravenous midazolam for sedation in mechanically ventilated paediatric patients 3 to 17 (less than 18) years old
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Paediatric patients at least 3 years to 17 (less than 18, patients who will turn 18 years during the study [including follow-up] will not be included) years at the time of randomisation, admitted to an ICU/with planned ICU admission
- •2. Expected mechanical (invasive) ventilation and sedation for at least 12 hours
- •3. Informed consent obtained from the patient, patient’s legal guardian(s) as required by local regulations. Where applicable, assent obtained from the patient to participate in the clinical study
排除标准
- •1. Ongoing seizures requiring acute treatment
- •2. Continuous sedation for more than 72 hours at the time of randomisation
- •3. Less than 24 hours post cardiopulmonary resuscitation
- •4. Uncompensated circulatory shock
- •5. Known hypersensitivity to isoflurane or to other halogenated anaesthetics (such ashalothane), benzodiazepines, non-investigational medicinal product(s) (analgesics, additional rescue sedatives that may be required during the study) or to any of their formulation ingredients
- •6. Known or suspected genetic susceptibility to malignant hyperthermia
- •7. Patients with acute asthma or obstructive lung disease symptoms requiring treatment at inclusion
- •8. Patient with tidal volumes below 30 ml or above 800 ml
- •9. Inability to perform reliable COMFORT-B assessment in the opinion of the Investigator e.g. due to (not limited to): severe traumatic brain injury, intracranial pathology (tumour, haemorrhage, infections), with a profound effect on the level of consciousness, severe mental retardation, major congenital anomalies of the central nervous system, severe myasthenia gravis, spinal muscular atrophy, or another severe neurologic disease, ongoing neuromuscular blockade which precludes COMFORT-B scoring.
- •10. Patients with intracranial pressure (ICP) monitoring or with a suspected increase in ICP
- •11. Patients with treatment-induced whole-body hypothermia
- •12. Patients with pheochromocytoma
- •13. Patients with prolonged QT interval or with significant risk for prolonged QT interval
- •14. Patient not expected to survive next 48 hours or not committed to full medical care
- •15. Female patients who are pregnant or breastfeeding
- •16. Previous participation in the study (a patient can only participate once)
- •17. Known participation in any other clinical study that included drug treatment within three months of the first administration of the IMP
- •18. Any for the study relevant medical history, or ongoing clinically significant disease, disorder or laboratory result which, in the opinion of the Investigator, precludes participation in the study for medical or ethical reasons
研究者
相似试验
进行中（未招募）
1 期
A Study to Compare the Effect and Safety of Inhaled Isoflurane to Intravenous Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years OldSedation in Mechanically Ventilated Paediatric Patients 3 to 17 (Less than 18) Years OldMedDRA version: 20.0Level: PTClassification code 10039897Term: SedationSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: LLTClassification code 10049683Term: Monitored anesthesia care sedationSystem Organ Class: 100000004865MedDRA version: 21.1Level: LLTClassification code 10062825Term: Monitored anaesthesia care sedationSystem Organ Class: 100000004865EUCTR2020-000578-31-FRSedana Medical AB160
进行中（未招募）
1 期
A Study to Compare the Effect and Safety of Inhaled Isoflurane to Intravenous Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years OldEUCTR2020-000578-31-SESedana Medical AB100
进行中（未招募）
1 期
A Study to Compare the Effect and Safety of Inhaled Isoflurane to Intravenous Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years OldSedation in Mechanically Ventilated Paediatric Patients 3 to 17 (Less than 18) Years OldMedDRA version: 20.0Level: PTClassification code 10039897Term: SedationSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: LLTClassification code 10049683Term: Monitored anesthesia care sedationSystem Organ Class: 100000004865MedDRA version: 21.1Level: LLTClassification code 10062825Term: Monitored anaesthesia care sedationSystem Organ Class: 100000004865EUCTR2020-000578-31-DESedana Medical AB100
尚未招募
4 期
To compare which one,out of dexamethasone and clonidine provides better pain relief when added as an additive in transversus abdominis plane blockCTRI/2023/02/049738ady Hardinge Medical College
尚未招募
3 期
A clinical trial to study effect of Katphal deccoction gargles and Triphaladi deccoction gargles in management of dental cariesCTRI/2022/12/047942Tilak Ayurved Mahavidyalay Pune