A Phase 4 interventional study of Propofol and Electroencephalogram recording in Propofol Overdose and EEG, sponsored by University of Chile. Completed at 2 sites in Chile. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by University of Chile · Phase 4, Interventional, and Basic science
In the world, 230 million surgeries are performed per year and a significant part is performed in patients over 65 years of age. These patients are more labile, especially from the neurocognitive point of view with a high risk to develop neurocognitive complications, such as postoperative delirium. Recent studies have linked this type of complication with an overdose of general anesthetics during surgery. For this reason, in recent years, the use of brain function monitors during the intraoperative period has been recommended to adapt the dosage of the drugs to each patient and thus to avoid overdosing of general anesthetics. However, to date, the available monitors that process the electroencephalographic signal are not able to adequately discriminate gradual changes in anesthetic depth. Also, no systematic studies have been performed that analyze changes that occur in the electroencephalogram (EEG) signal secondary to increases in complications from general anesthetics. Thus, the investigators design this study with the main aim to determine the changes in electroencephalographic patterns induced by a stepped increase of propofol until the burst suppression is reached.
The investigators will carry out a prospective analytical observational clinical study at the Clinical Hospital of the University of Chile. In total 15 patients will be recruited, in who a frontal electroencephalographic signal will be recorded using a SedLine® monitor, and propofol concentration will be estimated using the Marsh model. First, the concentration of propofol at the loss of consciousness (LOS) will be recorded in the presence of remifentanil (7.5 ng/mL). Then, patients will be intubated and remifentanil will be decreased to 4 ng/mL. After that, the concentration of propofol that caused the LOS will be maintained for 20 minutes. Finally, propofol will be increased in steps of 0.3 mcg/mL for 7 min, until an episode of burst suppression will be observed. In the complete protocol, EEG activity will be acquired using a SedLine® monitor.
139 studies on the registry are indexed under Drug Overdose; 24 are open to participants now.
This study's enrollment of 15 is below the median of 100 across 98 interventional studies indexed under Drug Overdose.
Browse Drug Overdose studies →University of Chile is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
1. - Concentration of propofol at the loss of consciousness (LOS) will be recorded in the presence of remifentanil (7.5 ng/mL) (LOS time). 2. - Patients will be intubated and remifentanil will be decreased to 4 ng/mL. 3. - Concentration of propofol that caused the LOS will be maintained for 20 minutes (Baseline time). 4. - Propofol will be increased in steps of 0.3 mcg/mL for 7 minutes until an episode of burst suppression will be observed (Burst suppression time). EEG activity will be acquired using a SedLine® monitor during the complete protocol.
Drug: Propofol · Device: Electroencephalogram recording
Stepped propofol concentration after 20 min of LOS
Also known as: Dosage increase
Acquisition of EEG activity
Change in the alpha power of EEG Spectrogram
% of change
Time frame: Change between baseline time (0 minutes) and burst suppression time (35 minutes)
Change in the delta power of EEG Spectrogram
% of change
Time frame: Change between baseline time (0 minutes) and burst suppression time (35 minutes)
Change in the coherence
% of change
Time frame: Change between baseline time (0 minutes) and burst suppression time (35 minutes)
Change in the propofol concentration
concentration in mcg/mL
Time frame: Change between baseline time (0 minutes) and burst suppression time (35 minutes)
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University of Chile