E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative REM sleep reduction after fast-track hip and knee arthroplasty. Comparison of preoperative level and level of REM on first postoperative night. The effect of one administration of Zolpidem 10 mg on the first postoperative night compared to placebo treated group. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036160 |
E.1.2 | Term | Poor sleep |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 |
To investigate the effect of Zolpidem treatment on the level of REM sleep on the first postoperative night after fast-track hip and knee atrhoplasty. REM sleep is evaluated as a comparison with measurement from preoperative night |
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E.2.2 | Secondary objectives of the trial |
1. Ændring i søvnstadie N1, N2, N3 af total søvn tid og total søvn tid første postoperative nat i forhold til den præoperative måling 2. Ændring i vågen tid om natten første postoperative nat i forhold til den præoperative måling 3. Det total morfinforbrug i perioden til 24 timer efter operationens afslutning 4. Træthed score på numerisk rating skala (NRS) morgenen efter præoperativ søvnmåling kontra morgenen efter postoperative måling 5. VAS score umiddelbart efter søvnmonitorering 6. VAS score som recall for hele natten efter søvnmonitorering
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patienter, som skal gennemgå elektiv TKA eller THA i accelereret regi • Alder > 60 år • ASA-klasse I-III.
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E.4 | Principal exclusion criteria |
• Operation i anæstesi indenfor de sidste 30 dage. • Dagligt forbrug af alkohol > 21 genstande ugentligt. • Forbrug af sovemedicin eller anxiolytika indenfor de sidste 30 dage • Manglende evne til at læse og forstå dansk • Betydelig nedsat syn- eller hørelse • Parkinsons sygdom eller andre neurodegenerative/iskæmiske cerebrale lidelser med betydelig påvirkning af funktionsniveau, inklusive tidligere alvorligt kranietraume. • Patienter som ikke kan samarbejde til søvnmonitorering • Allergi overfor stofferne anvendt i undersøgelsen
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Ændring i REM søvnsandel af total søvn tid første postoperative nat i forhold til den præoperative måling. |
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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 | Yes |
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 | 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 | No |
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.8.3 |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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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Inclusion of 20 patients who have all fulfilled the study period and followed the protocol will mark the end of the study. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |