E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The patients who undergo abdominal surgeries (laparotomy or laparoscopy) under desflurane anaesthesia will be investigated. |
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E.1.1.1 | Medical condition in easily understood language |
The surgial patients who receive abdominal operations under general anaesthesia with desflurane will be investigated. |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018060 |
E.1.2 | Term | General anaesthesia |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014275 |
E.1.2 | Term | EEG |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10002091 |
E.1.2 | Term | Anaesthesia |
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 |
To analyze physiological reactions to noxious stimuli, i.e., nociception-associated changes in EEG, Entropy and BIS index values, heart rate, or heart rate variability is the main objective. |
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E.2.2 | Secondary objectives of the trial |
To analyze EEG-arousals caused by noxious stimuli, and that observed during the recovery from general anaestheia. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Obtained written informed consent to assign the study
2. Age range 18-64 years
3. Elective abdominal surgery (laparotomy, laparoscopy)
4. General anaesthesia
5. American Society of Anesthesiologist Classification of Physical Status 3 or less |
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E.4 | Principal exclusion criteria |
1. Pregnancy
2. Body mass index more than 30
3. Disease affecting CNS, autonomic nervous system, heart, heart rate, or circulation
4. Chronic use of drugs affecting CNS, autonomic nervous system, heart, heart rate, or circulation; except antihypertensives, which are acceptable in this study
5. Serious psychiatric diseases or disorders
6. Overuse of alcohol
7. Use of illicit drugs
8. Unability of understand, read or use Finnish language
9. History of allergic reactions to any of the drugs used during anaesthesia
10. History or family history of malignant hyperthemia |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end point is the behaviour of Entropy and BIS index values, raw EEG signal, heart rate, and heart rate variability to the noxious stimuli and the time patients regain consciousness after anaesthesia. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The data will be obtained from the beginning of anaesthesia until the patients showing EEG-arousal after anaesthesia. |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |