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 |
Post operative Nausea and vomiting |
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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 occurance of postoperative Nausea and vomiting (PONV) does not differ significantly from Placebo and Vitamin C Group (branches A and B). |
Das Auftreten von postoperativer Übelkeit und /oder Erbrechen (PONV) unterscheidet sich nicht statistisch signifikant zwischen der Placebo- und der Vitamin C-Gruppe (Studienäste A und B). |
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E.2.2 | Secondary objectives of the trial |
The intraoperative trend of Histamin levels of the Vitamin C and the Antihistamin group (branches B and C) does not differ from each other. |
Es kommt intraoperativ zu keinem unterschiedlichen Verlauf der Histaminwerte zwischen der Vitamin C und der Antihistamingruppe (Äste B und C). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All patients who undergo a primary elecitve knee or hip total endoprothesis surgery (1500 patients per year) in the Orthopaedics Hospital Speising
between age 18-80 years
ASA Group I or II
presenting at least 2 out of 4 of following PONV risk factors: female, non-Smoking, PONV history, kinetosis |
Einschlusskriterien:
• Alle Patienten, die sich im Orthopädischen Spital Speising einer primären elektiven Knie- oder Hüft-TEP- Operation (ca. 1500 Pat. Im Jahr) unterziehen
• zwischen ihrem 18. und 80. Geburtstag sind
• in die ASA Gruppen I oder II fallen
• mindestens 2 der 4 folgenden PONV – Risikofaktoren aufweisen: weiblich, Nichtraucher, PONV in der Anamnese, Kinetose (See- und Reisekrankheit).
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E.4 | Principal exclusion criteria |
children
Age >80 years
Smoking men without PONV history and motion sickness
ASA Group III or IV
acute and other surgeries
pregnancy |
Ausschlusskriterien:
• Kinder
• Alter > 80 Jahre
• Rauchende Männer ohne PONV-Anamnese und See- und Reisekrankheit
• ASA Gruppen III oder IV
• Akute und andere Operationsgebiete
• Schwangerschaft
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E.5 End points |
E.5.1 | Primary end point(s) |
The main dependent variable is the occurance of PONV up to 48 hours after surgery (yes/no criteria) in the Placebo vs. Vitamin C Group. |
Die Hauptzielgröße ist das Auftreten von PONV bis spätestens 48 Stunden nach der Operation (ja/nein Kriterium) in der Placebo- vs. der Vitamin C Gruppe. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
48 hours after surgery |
48 Stunden nach der Operation |
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E.5.2 | Secondary end point(s) |
The main dependent variables are the intraoperative Histamin Levels in the Vitamin C vs the antihistamin Group (branch B vs Branch C). |
Die Hauptzielgröße sind die intraoperativen Histaminwerte in der Vitamin C (Ast B) vs. der Antihistamingruppe (Ast C). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
time Point 2 (immediately after Infusion)
time Point 3 (after induction of anaesthesia) |
Messzeitpunkt 2 (unmittelbar nach der Infusion)
Messzeitpunkt 3 (nach Anästhesieeinleitung) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
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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
| 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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |