E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Under investigation are elderly patients (≥65 years of age) undergoing each kind of surgery with planned general or combined regional and general anaesthesia. Primary, we will investigate the postoperative global patient satisfaction, depending on the kind of premedication (midazolam vs. placebo) of these patients. |
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E.1.1.1 | Medical condition in easily understood language |
Patient satisfaction of elderly patients (≥65yrs) undergoing each kind of surgery with planned general or combined regional and general anaesthesia, depending on midazolam application before surgery. |
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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 |
We aim to assess, if placebo administration compared to preoperative administration of midazolam in elderly patients is equal in regard to the global postoperative patient satisfaction. |
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E.2.2 | Secondary objectives of the trial |
We aim to assess, if placebo administration compared to preoperative administration of midazolam in elderly patients is equal in regard to the preoperative cooperation, the postoperative emergence and recovery after anaesthesia, well-being, pain, sleep, health-related quality of life and mortality or serious cardiac or pulmonary complications, acute stroke, or acute kidney injury up to 30 days after surgery, postoperative adverse events and gender effects.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Only legally competent patients 2. Written informed consent prior to study participation 3. 65-80 years 4. Elective surgery 5. Expected surgery duration ≥ 30 minutes 6. Planned general or combined regional and general anaesthesia 7. Planned extubation at the end of surgery
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E.4 | Principal exclusion criteria |
1. Age > 80 years 2. Age < 65 years 3. Non-fluency in German language 4. Alcohol and/ or drugs abuse 5. Chronic benzodiazepine treatment 6. Intracranial surgery 7. Local and stand by anaesthesia or solely regional anaesthesia 8. Monitored anaesthesia care 9. Cardiac surgery 10. Ambulatory surgery 11. Repeated surgery 12. Contraindications for benzodiazepine application (e.g. sleep apnoea syndrome, severe chronic obstructive pulmonary disease, allergy) 13. Allergy against any component of the Placebo (lactose monohydrate, cellulose powder, magnesium stearate, microcrystalline cellulose) orinvestigational drug (midazolam, lactose) or the capsules (gelatine, E171 titanium dioxide, E132 indigotine) 14. Expected benzodiazepine requirement after surgery 15. Expected continuous mandatory ventilation after surgery 16. Patients who explicitly request anxiolytic premedication 17. Patients with severe neurological or psychiatric disorders 18. Refusal of study participation by the patient 19. Parallel participation in interventional clinical studies within the last 30 days
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E.5 End points |
E.5.1 | Primary end point(s) |
Global patient satisfaction, assessed by the EVAN-G questionnaire
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Global patient satisfaction assessed on the first postoperative day |
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E.5.2 | Secondary end point(s) |
• Assessment of preoperative anxiety • Assessment of preoperative frailty • Functional and cognitive recovery • Postoperative delirium • Perioperative condition of well-being, pain and sleeping • Number of patients with rescue midazolam application • Patient cooperation directly preoperatively • Time to extubation • Health-related quality of life assessment before and 30 days after surgery • Longer-term outcome after 30 days including mortality or the new-onset of serious cardiac or pulmonary complications, acute stroke, or acute kidney injury • Subgroup analysis according to the preoperative anxiety level, the patient demographics and surgery experience • Adverse events (AEs) and serious adverse events (SAEs) according to the medical charts • Gender effects on the primary outcome • Hospital length of stay (LOS) and intensive care unit (ICU)-LOS
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
T0= Preoperatively/Baseline,T1=surgery day before surgery,T2=surgery, T3=surgery day after surgery, T4=First postoperative day, T5=Day 30 after surgery T0: Preoperative anxiety T0: Preoperative frailty T0,T4,T5:Functional and cognitive recovery T0,T4: Postoperative delirium T0,T3:Well-being, pain and sleeping T1: Patient cooperation T2: Time to extubation T0,T5: Health-related quality of life T5: Longer-term outcome after 30 days including mortality or the new-onset of serious cardiac or pulmonary complications, acute stroke, or acute kidney injury T3, T4: AEs and SAEs T0-T5: Gender effects and subgroup analysis according to the preoperative anxiety level, the patient demographics and surgery experience T5: Hospital length of stay (LOS) and ICU-LOS
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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 | Yes |
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 | No |
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 | Yes |
E.8.2.3 | Other | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |