E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
otherwise healthy patients undergoing an operation necessitating general anaesthesia |
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E.1.1.1 | Medical condition in easily understood language |
healthy pediatric patients who come to an operation which is done under general anaesthesia |
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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 |
Our aim is to study the effects of remifentanil on the entropy measurement in paediatric patients during general anaesthesia. |
Tutkimuksen tavoitteena on selvittää remifentaniilin vaikutukset entropiaan (RE, SE, RE-SE-ero) lapsipotilailla yleisanestesian yhteydessä |
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E.2.2 | Secondary objectives of the trial |
2. To evaluate the effects of surgery pain and remifentanil analgesia to surgigal pleth index (SPI) and entropy measurement and their microdeviation.
3. To evaluate the usefulnes of entropy-measurement in assessing awakening from general anaesthesia.
4. To evaluate the usefulness of target-controlled infusion -dosing during awakening period of anaesthesia.
5. To create pharmacokinetic-pharmacodynamic model for remifentanil to be used in target controlled analgesia in pediatric patients.
6. To characterise propofol-remifentanil drug interactions
7. To characterise genomic factors affecting remifentanil analgesia.
8. To characterise remifentanil induced changes in protein expression. |
2. Selvittää leikkauskivun ja remifentaniilin vaikutukset surgical pleth index:iin (SPI) ja sekä SPI:n ja entropiamittauksen mikrodeviaatioon (ΔSPI, ΔRE, ΔSE).
3. Tutkia entropian toimivuus anestesiasta heräämisessä.
4. Tutkia propofolin TCI-annostelun toimivuus erityisesti heräämisvaiheessa.
5. Mallintaa remifentaniilin farmakokinetiikka ja –dynamiikka remifentaniilin TCI-annostelun mahdollistamiseksi lapsipotilailla.
6. Tutkia ja mallintaa remifentaniilin ja propofolin yhteisvaikutuksia.
7. Selvittää remifentaniilin kivunlievitykseen vaikuttavat geneettiset tekijät.
8. Selvittää remifentaniilin aiheuttamat muutokset elimistön proteiinien synteesissä ja ilmentymisessä.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient is 3-15 years old (body weight (15-61 kg). Patients ASA class is 1-2. Patient comes to an elective surgery which necessitates general anesthesia. Operation time is appr. 1.5-6 hours |
Potilas on 3-15 vuotias (paino 15-61 kg), Potilaan ASA-luokka on 1-2, Potilaalle on suunniteltu elektiivinen yleisanestesian vaativa arviolta 1.5-6 tuntia kestävä toimenpide. |
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E.4 | Principal exclusion criteria |
Patient has a disease or trauma affecting the state of consciousnes or encephaloelectrogram measurement. Patient comes to a head or neck surgery. Anaesthesia cannot be induced via intravenous route. The researchers cannot place the second iv-cannula. Muscle relaxant is needed. Patient or his/her guardians refuse to take part in the study |
Potilaalla on tiedossa oleva tajunnan tasoon tai aivosähkökäyrään vaikuttava sairaus tai vamma. Suunniteltu toimenpide kohdistuu päähän tai kaulaan. Anestesian induktio ei onnistu laskimoteitse. Potilaalle ei saada toista laskimokanyylia. Joudutaan käyttämään lihasrelaksanttia. Potilas tai hänen vanhempansa kieltävät potilaan osallistumisen tutkimukseen. |
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E.5 End points |
E.5.1 | Primary end point(s) |
All the planned SPI and entropy measurements have been done. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 hours after the start of remifentanil dosing. |
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E.5.2 | Secondary end point(s) |
All the planned blood samples have been drawn. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
24 hours after the start of remifentanil dosing |
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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 | No |
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 | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
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 | 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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24 hour after the start of remifentanil dosing, when the surgery is completed as planned and all the measurements and blood samples have been taken or drawn. |
24 tuntia remifentaniilin annostelun alkamisesta, kun leikkaus on saatu tehdyksi suunnitellusti, ja kaikki suunnitellut näytteet on otettu ja mittaukset on tehty. |
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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 | |