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To collect and analyze the electroencephalogram (EEG) signal from the patients, anaesthetized with desflurane.

Arousal reaction during desflurane anaesthesia - Deaflurane and arousal

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-003172-36-FI
Enrollment
Unknown
Registered
2011-08-25
Start date
2011-10-07
Completion date
Unknown
Last updated
2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The patients who undergo abdominal surgeries (laparotomy or laparoscopy) under desflurane anaesthesia will be investigated. MedDRA version: 14.0 Level: PT Classification code 10018060 Term: General anaesthesia System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.0 Level: LLT Classification code 10014275 Term: EEG System Organ Class: 10022891 - Investigations MedDRA version: 14.0 Level: PT Classification code 10002091 Term: Anaesthesia System Organ Class: 10029205

Interventions

Trade Name: Suprane Product Name: Desflurane Pharmaceutical Form: Inhalation vapour

Sponsors

Department of Anaesthesia, Tampere University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Finland

Contacts

Public ContactTampere University Hospital

Department of Anaesthesia, Tampere University Hospital

arvi.yli-hankala@pshp.fi+358503415524

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026