EUCTR2016-000406-11-NL进行中（未招募）不适用
The influence of electroencephalographic Narcotrend Index™ - guidance of propofol administration on recovery from procedural sedation for gastrointestinal endoscopy in children between 1 and 12 years - NI-PPS 2
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Written informed consent of patients and their parents/legal representatives
- •Age =1 and <12 years
- •Bodyweight >5 and = 60 kg (limitation of the paediatric TCI model)
- •Gastrointestinal endoscopy
- •Eligibility for PS
- •Ability of the patients' parents or legal guardians and patients = 6 years to communicate in Dutch
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Primary exclusion criteria
- •Withdrawal of informed consent
- •Chronic exposure (more than one day) to psychotropic drugs and/or opioids
- •Known allergy/intolerance for propofol and/or remifentanil
- •Anticipated difficult airway
- •Child not eligible for PS, need for inhalation induction and general anaesthesia
- •Parents/ legal guardians and/or patients = 6 years unable to communicate in Dutch
- •Secondary exclusion criteria
- •Unexpected need for inhalation induction of general anaesthesia due to major difficulties to ob-tain intravenous access.
- •Unexpected procedural events requiring endotracheal intubation
研究者
相似试验
尚未招募
不适用
The influence of electroencephalographic Narcotrend IndexTM- guidance of propofol administration on recovery from procedural sedation for gastrointestinal endoscopy in children between 1 and 12 yearsonderzoek tijdens procedurele sedatie bij kinderen, niet gerelateerd aan specifieke aandoeningenNL-OMON43430Erasmus MC, Universitair Medisch Centrum Rotterdam40
招募中
不适用
Endoscopy with EEG-control in children between 1 and 12 yearsSedation, Propofol, Children, Endoscopy, EEGNL-OMON23511Erasmus University Medical Center, Sophia Children's Hospital, Department of AnaesthesiaRotterdam, The Netherlands40
进行中（未招募）
不适用
Endoscopic examination of the digestive tract in children under sedation with advanced monitoring equipmentThere is no medical condition which is under investigation.Paediatric patients, scheduled for gastrointestinal endoscopy under procedural sedation are eligible for inclusion.Depth of sedation will be assessed either by processed EEG analysis or by clinical surrogate parameters. Based on that assessement propofol is delivered.EUCTR2013-002122-23-NLErasmus University Medical Center
尚未招募
不适用
The influence of electroencephalographic Narcotrend Index*- guidance of propofol administration on recovery from procedural sedation for gastrointestinal endoscopy in paediatric patientsonderzoek tijdens procedurele sedatie bij kinderen, niet gerelateerd aan specifieke aandoeningenNL-OMON38989Erasmus MC, Universitair Medisch Centrum Rotterdam40
已完成
不适用
Endoscopy with EEG-contolSedationPropofolChildrenGastrointestinal endoscopyDepth of Anaesthesia MonitoringEEGNL-OMON28327Erasmus University Medical CenterSophia Children's HospitalRotterdamThe Netherlands40