E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Surgical patients scheduled for elective surgery under general anaesthesia. Otherwise in stable medical condition (ASA status less than 3) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023693 |
E.1.2 | Term | Laparoscopy |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023696 |
E.1.2 | Term | Laparotomy |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023697 |
E.1.2 | Term | Laparotomy & drainage |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051777 |
E.1.2 | Term | Staging laparotomy |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053361 |
E.1.2 | Term | Explorative laparotomy |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069054 |
E.1.2 | Term | Pelvic laparoscopy |
|
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 |
In the present study we will obtain the EEG from relatively healthy (ASA-PS less than 3) patients undergoing desflurane anaesthesia. We will increase and decrease the desflurane concentrations and correlate the behaviour of raw EEG. |
|
E.2.2 | Secondary objectives of the trial |
To commercially available indices (BIS and Entropy) and to the concentration of desflurane. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Enrollment criteria of the patients are: - obtained written informed consent to assign the study. - age range from 18 to 70 years old. - scheduled for abdominal surgical procedures planned to last for more than 90 minutes, and requiring general anaesthesia with tracheal intubations and epidural analgesia for postoperative pain treatment. - American Society of Anesthesiologists Classification of Physical Status 3 or less.
|
|
E.4 | Principal exclusion criteria |
Exclusion criteria of the patients are: - pregnancy. - obesity defined as BMI > 30. - any significant cardiovascular, respiratory or neurological diseases. - any significant disorders of the autonomic and central nervous systems. - receiving medication known to affect the central nervous system activity (receiving medication for hypertension is not exclusion criteria). - overuse of alcohol, use of illicit drugs. - family history of malignant hyperthermia. - clinical history of anaphylactic reaction against inhaled anaesthetics. - disablity to communicate with Finnish language.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is the behaviour of EEG as a function of desflurane concentration.
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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 | Yes |
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 | Information not present in EudraCT |
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 | 3 |
E.8.9.1 | In the Member State concerned days | |