Electroencephalogram during increasing and decreasing desflurane concentration - Electroencephalogram change by desflurane

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014620-36-FI

Enrollment

Registered

2009-09-23

Start date

2009-12-17

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Surgical patients scheduled for elective surgery under general anaesthesia. Otherwise in stable medical condition (ASA status less than 3) MedDRA version: 12.0 Level: LLT Classification code 10023693 Term: Laparoscopy MedDRA version: 12.0 Level: LLT Classification code 10023696 Term: Laparotomy MedDRA version: 12.0 Level: LLT Classification code 10023697 Term: Laparotomy & drainage MedDRA version: 12.0 Level: LLT Classification code 10051777 Term: Staging laparotomy MedDRA version: 12.0 Lev

Interventions

Trade Name: SUPRANE® (Rec) Product Name: SUPRANE® (Rec) Pharmaceutical Form: Inhalation gas INN or Proposed INN: DESFLURANE CAS Number: 57041675

Eligibility

Sex/Gender

All

Inclusion criteria

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. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: To commercially available indices (BIS and Entropy) and to the concentration of desflurane. ;Primary end point(s): Primary endpoint is the behaviour of EEG as a function of desflurane concentration.	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: To commercially available indices (BIS and Entropy) and to the concentration of desflurane. ;Primary end point(s): Primary endpoint is the behaviour of EEG as a function of desflurane concentration.

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Countries

Finland

Outcome results

None listed

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