E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
There is no specific medical condition under investigation |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is the effect of Narcotrend Index (NI) monitoring on the speed of recovery from Procedural Sedation (PS) for paediatric gastrointestinal endoscopy (PGE). Speed of recovery is defined as the time interval between the end of hypnotic drug application and the moment when discharge criteria from the operating room are met. |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints are: • Anaesthetic drug consumption • Total time from discontinuation of anaesthetic drug delivery until discharge from the post anaesthe¬sia care unit • Posthoc intergroup comparison of hypnotic depth as measured by NI • Recall of events during the procedure (awareness), only in patients > 6 years. • Assessment of endoscopy conditions (by paediatric gastroenterologist) • Adverse events
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• 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
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E.4 | Principal exclusion criteria |
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
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E.5 End points |
E.5.1 | Primary end point(s) |
The time interval between the end of anaesthetic drug application and the moment when discharge criteria from the operating room are met (Steward Score ≥3) is compared between the study groups. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
immediately after the end of the endoscopic procedure |
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E.5.2 | Secondary end point(s) |
• Cumulative anaesthetic drug consumption • Total time from discontinuation of anaesthetic drug delivery until discharge from the post anaesthesia care unit • Posthoc intergroup comparison of hypnotic depth as measured by Narcotrend • Incidence of recall of events during the procedure (awareness) • Assessment of endoscopy conditions (by paediatric gastroenterologist) • Adverse events
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
On the PACU and (2nd and 3rd interview) at days 1 and 14 after the procedure |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
EEG-based depth of hypnosis (DoH) monitoring may result in faster recovery from procedural sedation. From a scientific view it is the key question whether the application of DoH monitoring in the particular setting of sedation for gastrointestinal endoscopy in children between 1 and 12 years results in advantages for both the patients (faster recovery) and the health care providers (enhanced workflow) |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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after inclusion of a total of 40 patients (20 in each study arm). sample size justified by a-priori power analysis |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |