E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
unpleasant sensations of inner restlessness |
impossibilité de s'asseoir ou de rester dans la position assise |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10001540 |
E.1.2 | Term | Akathisia |
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 |
Assess the incidence of akathisia caused by droperidol (administrated at two different doses for postoperative nausea and vomiting prophylaxis) versus control group (ondansetron) in ambulatory surgery. |
Évaluer l'incidence de l'akathisie au décours du traitement prophylactique des NVPO par le dropéridol (utilisé à deux doses différentes) versus groupe contrôle (ondansetron), en chirurgie ambulatoire |
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E.2.2 | Secondary objectives of the trial |
1) Assess the incidence of akathisia caused by droperidol (0,625 mg) versus droperidol (1,25 mg) administrated for postoperative nausea and vomiting prophylaxis in ambulatory surgery.
2) Assess the incidence of postoperative nausea and vomiting treated by droperidol (two different doses) versus control group (ondansetron) in ambulatory surgery. |
- Évaluer l'incidence de l'akathisie au décours du traitement prophylactique des NVPO par le dropéridol (0,625 mg) versus dropéridol (1,25 mg), en chirurgie ambulatoire.
- Évaluer l'incidence des NVPO au décours du traitement prophylactique des NVPO par le dropéridol (utilisé à deux doses différentes) versus groupe contrôle (ondansetron), en chirurgie ambulatoire.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Women < 18 years old - Moderate or severe risk of postoperative nausea and vomiting (at least 2 risk factors at simplified Apfel score) - Hospitalized in ambulatory surgery - General anesthesia planned |
- Femme de plus de 18 ans - Présentant un risque modéré à sévère de NVPO (Nausées et Vomissements Post-Opératoires) (au moins deux facteurs de risque au score simplifié d'Apfel) -Hospitalisée en chirurgie ambulatoire et devant bénéficier d’une anesthésie générale
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E.4 | Principal exclusion criteria |
- Contraindication to droperidol - Contraindication to ondansetron - Patients treated with benzodiazepine treatment or having received benzodiazepine within 2 days prior to anesthesia - Psychiatric diseases or neurodegenerative diseases - Severe Anxiety - Contraindication to general anesthesia or one of its components - Pregnancy reported by the patient - Breastfeeding |
- Contre-indication au dropéridol - Contre-indication à l’ondansetron - Patientes traitées par benzodiazépine en traitement de fond ou en ayant reçu dans les 2 jours précédant l’anesthésie - Maladies psychiatriques ou neurodégénératives - Anxiété sévère - Contre-indication à l’anesthésie générale ou à une de ses composantes - Grossesse déclarée par la patiente - Allaitement
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E.5 End points |
E.5.1 | Primary end point(s) |
number of akathisia (Barnes score <1) observed in droperidol arm (0,625 mg and 1,25 mg) versus ondansetron 4mg arm |
nombre d’akathisies observées (score de Barnes >1) dans le bras droperidol (0,625 mg et 1,25 mg) versus bras ondansetron 4mg |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
4 hours following awakening from anesthesia |
4h après le réveil d’anesthésie |
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E.5.2 | Secondary end point(s) |
1) number of akathisia (Barnes score <1) observed in droperidol arm (0,625 mg and 1,25 mg) versus ondansetron 4mg arm 2) number of akathisia (Barnes score <1) observed in droperidol 0,625 mg arm versus droperidol 1,25 mg arm 3) nausea score (1-10) observed in droperidol arm (0,625 mg and 1,25 mg) versus ondansetron 4mg arm 4) vomiting number observed in droperidol arm (0,625 mg and 1,25 mg) versus ondansetron 4mg arm |
1) nombre d’akathisies observées (score de Barnes >1) dans le bras droperidol (0,625 mg et 1,25 mg) versus bras ondansetron 4mg 2) nombre d’akathisies observées (score de Barnes >1) dans le bras droperidol 0,625 mg versus bas droperidol 1,25 mg 3) score de nausées (1-10) dans le bras droperidol (0,625 mg et 1,25 mg) versus bras ondansetron 4mg 4) nombre de vomissements dans le bras droperidol (0,625 mg et 1,25 mg) versus bras ondansetron 4mg |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) 24h following awakening from anesthesia 2) 4h and 24h following awakening from anesthesia 3) 4h and 24h following awakening from anesthesia 4) 4h and 24h following awakening from anesthesia |
1) 24 h après le réveil d'anesthésie 2) 4h et 24h après le réveil d'anesthésie 3) 4h et 24h après le réveil d'anesthésie 4) 4h et 24h après le réveil d'anesthésie |
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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 | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 3 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |