To collect and analyze the electroencephalogram (EEG) signal from the patients, anaesthetized with desflurane.
- Conditions
- The patients who undergo abdominal surgeries (laparotomy or laparoscopy) under desflurane anaesthesia will be investigated.MedDRA version: 14.0Level: PTClassification code 10018060Term: General anaesthesiaSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: LLTClassification code 10014275Term: EEGSystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.0Level: PTClassification code 10002091Term: AnaesthesiaSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2011-003172-36-FI
- Lead Sponsor
- Department of Anaesthesia, Tampere University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: To analyze EEG-arousals caused by noxious stimuli, and that observed during the recovery from general anaestheia.;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.;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.
- Secondary Outcome Measures
Name Time Method