E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study aims to investigate the effect of a clinically used dose of Pregabalin on the Cp50 of propofol to provide more information to clinicians using this adjunctive drug in the perioperative setting. |
Das Ziel dieser Studie ist es, den Effekt einer klinisch üblichen Dosis von Pregabalin auf die Cp50 von Propofol zu untersuchen. |
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E.1.1.1 | Medical condition in easily understood language |
This study aims to investigate the effect of aclinically used dose of Pregabalin on propofol, which is a routinely used anaesthetic agent. |
Das Ziel dieser Studie ist es, den Effekt von einer klinisch üblichen Dosis von Pregabalin auf das Routinenarkosemedikament Propofol zu untersuchen. |
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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 |
This study aims to investigate the effect of a clinically used dose of Pregabalin on the Cp50 of propofol to provide more information to clinicians using this adjunctive drug in the perioperative setting. |
Das Ziel dieser Studie ist es, den Effekt einer klinisch üblichen Dosis von Pregabalin auf die Cp50 von Propofol zu untersuchen. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
We will include only adult patients aged 30-60 years of the ASA classes 1-2 and a BMI between 18.5 and 30, undergoing elective surgery under general anaesthesia with a skin incision of at least 3 cm at the trunk. |
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E.4 | Principal exclusion criteria |
Patients not able to understand the study procedure, patients needing premedication with sedative or analgesic drugs, patients with a history of chronic pain, patients that regularly take pregabalin, patients in whom propofol or pregabalin is contraindicated, patients with a known allergy to one of the study medications and pregnant or breastfeeding patients cannot be included in the study. Also, patients with a history of intraoperative awareness will be excluded. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Response to skin incision |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Blood samples for plasma propofol concentrations will be taken 15 and 20 minutes after induction of anaesthesia. Blood samples for the serum pregabalin concentration will be taken immediately before skin incision. All samples will be taken via the arterial line to minimise trauma to the patients. Arterial blood sampling for the determination of plasma or serum concentrations of drugs that are applied continuously via an intravenous line is common practice as it reduces the risk of concentration fluctuations that may be present in the venous system. Heart rate, oxygen saturation, blood pressure, BIS values, endtidal CO2 concentration and body temperature will be documented every minute from the start of anaesthesia until two minutes after skin incision. Two minutes before and after the skin incision values will be documented every 30 seconds to allow for more precise monitoring during this critical phase. Furthermore, the exact location of the skin incision and detailed description of the motor response to skin incision (which extremities moved, character of the movement) will be documented. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From the start of anaesthesia until 2 minutes after skin incision |
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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 | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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.8.2.4 | 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 | 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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The end of trial is defined as compeletion of 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 | |