E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative pain |
Postoperativer Schmerz |
|
E.1.1.1 | Medical condition in easily understood language |
Pain after surgery |
Schmerz nach einer Operation |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
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 | 10036236 |
E.1.2 | Term | Postoperative pain relief |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
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 |
significantly reduced opoid consumption through continuous infusion of physostigmine during the first 24 hours after surgery |
signifikant reduzierter Opioidverbrauch durch die kontinuierliche Gabe von Physostigmin während der ersten 24 h Stunden postoperativ |
|
E.2.2 | Secondary objectives of the trial |
reduced VAS scores, lower incidence of side effects, reduced area of mechanical hyperalgesia |
reduzierte VAS-Scores, niedrigere Inzidenz an Nebenwirkungen, reduziertes mechanisches Hyperalgesieareal |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
at least 18 years of age at least 50 kg body weight PCA competent ASA1-3 |
Mind. 18 Jahre alt Mehr als 50 kg schwer Geeignet für PCA ASA 1-3
|
|
E.4 | Principal exclusion criteria |
Asthma, COLD, iritis, obstructive ileus, stenoses or spasms of the intestinal, bile, or urinary tract, closed head trauma, EF<30%, perioperative MI, stroke within the past 6 months known allergy, overreaction to or contraindications for hydromorphone, physostigmine a history of alcohol/drug abuse participant in another interventional study pregnancy |
Asthma bronchiale/schwere COPD, Iritis, Obstruktionsileus, Stenosen oder Spasmen des Darmtraktes, der Gallen- oder Harnwege, geschlossenes SHT, stark eingeschränkte linksventrikuläre Funktion (EF<30%), perioperativer Myocardinfarkt, Insult innerhalb der letzten 6 Monate Bekannte Allergie, Überempfindlichkeit oder Kontraindikationen gegen Hydromorphon, Physostigmin Alkohol- oder Drogenabusus in der Anamnese Teilnahme an einer anderen interventionellen Studie Bestehende/nicht ausgeschlossene Schwangerschaft
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
opioid requirement |
Opioidverbrauch |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 and 48 hours postoperative |
24 und 48 Stunden postoperativ |
|
E.5.2 | Secondary end point(s) |
VAS scores, side effects, areas of hyperalgesia |
VAS-Scores, Nebenwirkungen, Hyperalgesieareale |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
first 4 hours: every hour the next 8 hours: every second hour then every 4 hour (total of 48 hours) |
die ersten 4 Stunden: stündlich die nächsten 8 Stunden: zweistündlich dann alle 4 Stunden (insgesamt 48 Stunden) |
|
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 | 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) | 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) | 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
| 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
|
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |