NCT05112042|Completed
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Sponsor study identifier
observational
13
1 country
1
Study Start
May 14, 2022
Actual (reported)Primary Completion
March 1, 2023
Actual (reported)Study Completion
March 1, 2023
Actual (reported)The current evaluations of the levels of consciousness during anesthesia have limited precision. This can produce negative clinical consequences such as intraoperative awareness or neurological damage due to under- or over-infusion of anesthesia, respectively. The study's objective is to determine and classify biomarkers of electrical and hemodynamical brain activity associated with the levels of consciousness between wakefulness and anesthesia. For this purpose, a parietal electroencephalography (EEG) and a functional near-infrared spectroscopy (fNIRS) measurement paradigm will be used, as well as machine-learning. Volunteering patients (n = 25), who will be subject to an endoscopy procedure, will be measured during the infusion of anesthesia with propofol. EEG and fNIRS parameters will then be related to the Modified Ramsay clinical scale of consciousness.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 10, 2021
Actual (reported)November 8, 2021
Actual (reported)May 14, 2022
Actual (reported)March 1, 2023
Actual (reported)March 1, 2023
Actual (reported)Brain electrophysiological activity by electroencephalography wavelength band powers
The delta (0.1-3 Hz), theta (4-7 Hz), lower-alpha (8-12 Hz), upper-alpha (12-15 Hz), and beta/gamma (15-40 Hz) electroencephalography wavelength band powers will be used as features for the decoding model.
During the whole endoscopy and recovery (1 - 2 hours)
Temporal brain oxygenation by near-infrared light spectroscopy wavelengths
The temporal brain area of the oxygenated (HbO2) and deoxygenated (HHb) hemoglobin will be obtained from the optical signals, using the modified Beer-Lambert law.
During the whole endoscopy and recovery (1 - 2 hours)
Levels of Consciousness with the Modified Ramsay Sedation Scale
During infusion, the Modified Ramsay Scale will be used by the anesthetist in charge to measure the patient's level of consciousness. This scale has a total of eight levels, each of which indicates an increasing level of unconsciousness, assessed qualitatively by the patient's response to verbal or painful stimuli. The level of consciousness will be evaluated every two minutes until complete loss of consciousness, which is assumed after the loss of defensive or purposeful response to a second standard tetanic stimulation.
Relatively healthy volunteering patients, within 20 to 40 years of age, who will undergo an endoscopy procedure and meet all the eligibility criteria.
Centro de Especialidades Médicas UC
Santiago, Santiago Metropolitan, 8320000, Chile
Aru J, Suzuki M, Larkum ME. Cellular Mechanisms of Conscious Processing. Trends Cogn Sci. 2020 Oct;24(10):814-825. doi: 10.1016/j.tics.2020.07.006. Epub 2020 Aug 24.
Campbell JM, Huang Z, Zhang J, Wu X, Qin P, Northoff G, Mashour GA, Hudetz AG. Pharmacologically informed machine learning approach for identifying pathological states of unconsciousness via resting-state fMRI. Neuroimage. 2020 Feb 1;206:116316. doi: 10.1016/j.neuroimage.2019.116316. Epub 2019 Oct 29.
Catalina A Saini
Pontificia Universidad Catolica de Chile
13 participants (actual enrollment reported by the registry).
First Submitted
October 10, 2021
First Posted
November 8, 2021
Study Start
May 14, 2022
Actual (reported)Duration and Depth of Anesthesia Induced by a Bolus of Etomidate
20 minutes
BRICE survey responses
10 minutes
Contact the study team to confirm eligibility.
Davidson AJ. Anesthesia and neurotoxicity to the developing brain: the clinical relevance. Paediatr Anaesth. 2011 Jul;21(7):716-21. doi: 10.1111/j.1460-9592.2010.03506.x. Epub 2011 Apr 6.
Hirota K. Special cases: ketamine, nitrous oxide and xenon. Best Pract Res Clin Anaesthesiol. 2006 Mar;20(1):69-79. doi: 10.1016/j.bpa.2005.08.014.
Saadeh W, Khan FH, Altaf MAB. Design and Implementation of a Machine Learning Based EEG Processor for Accurate Estimation of Depth of Anesthesia. IEEE Trans Biomed Circuits Syst. 2019 Aug;13(4):658-669. doi: 10.1109/TBCAS.2019.2921875. Epub 2019 Jun 10.
Kotsovolis G, Komninos G. Awareness during anesthesia: how sure can we be that the patient is sleeping indeed? Hippokratia. 2009 Apr;13(2):83-9.
Lee, M. H., Fazli, S., Mehnert, J., & Lee, S. W. (2015). Subject-dependent classification for robust idle state detection using multi-modal neuroimaging and data-fusion techniques in BCI. Pattern Recognition, 48(8), 2725-2737. https://doi.org/10.1016/j.patcog.2015.03.010
Leon-Dominguez U, Izzetoglu M, Leon-Carrion J, Solis-Marcos I, Garcia-Torrado FJ, Forastero-Rodriguez A, Mellado-Miras P, Villegas-Duque D, Lopez-Romero JL, Onaral B, Izzetoglu K. Molecular concentration of deoxyHb in human prefrontal cortex predicts the emergence and suppression of consciousness. Neuroimage. 2014 Jan 15;85 Pt 1:616-25. doi: 10.1016/j.neuroimage.2013.07.023. Epub 2013 Jul 17.
Levitt DG, Schnider TW. Human physiologically based pharmacokinetic model for propofol. BMC Anesthesiol. 2005 Apr 22;5(1):4. doi: 10.1186/1471-2253-5-4.
Sheahan CG, Mathews DM. Monitoring and delivery of sedation. Br J Anaesth. 2014 Dec;113 Suppl 2:ii37-47. doi: 10.1093/bja/aeu378.
Sebel PS, Bowdle TA, Ghoneim MM, Rampil IJ, Padilla RE, Gan TJ, Domino KB. The incidence of awareness during anesthesia: a multicenter United States study. Anesth Analg. 2004 Sep;99(3):833-839. doi: 10.1213/01.ANE.0000130261.90896.6C.
Sepulveda P, Cortinez LI, Irani M, Egana JI, Contreras V, Sanchez Corzo A, Acosta I, Sitaram R. Differential frontal alpha oscillations and mechanisms underlying loss of consciousness: a comparison between slow and fast propofol infusion rates. Anaesthesia. 2020 Feb;75(2):196-201. doi: 10.1111/anae.14885. Epub 2019 Dec 1.
Sitaram R, Ros T, Stoeckel L, Haller S, Scharnowski F, Lewis-Peacock J, Weiskopf N, Blefari ML, Rana M, Oblak E, Birbaumer N, Sulzer J. Closed-loop brain training: the science of neurofeedback. Nat Rev Neurosci. 2017 Feb;18(2):86-100. doi: 10.1038/nrn.2016.164. Epub 2016 Dec 22.
Yeom SK, Won DO, Chi SI, Seo KS, Kim HJ, Muller KR, Lee SW. Spatio-temporal dynamics of multimodal EEG-fNIRS signals in the loss and recovery of consciousness under sedation using midazolam and propofol. PLoS One. 2017 Nov 9;12(11):e0187743. doi: 10.1371/journal.pone.0187743. eCollection 2017.
Zimeo Morais GA, Balardin JB, Sato JR. fNIRS Optodes' Location Decider (fOLD): a toolbox for probe arrangement guided by brain regions-of-interest. Sci Rep. 2018 Feb 20;8(1):3341. doi: 10.1038/s41598-018-21716-z.
Primary Completion
March 1, 2023
Actual (reported)Study Completion
March 1, 2023
Actual (reported)Last Updated
April 4, 2024
Record last verified: 2024-04
The Department of Anesthesiology and the Institute of Biological and Medical Engineering (IIBM) of the Pontificia Universidad Católica de Chile, will take the necessary measurements to protect the access to your clinical information and sensible data from unauthorized people. All the obtained information will be kept confidential. The name, ID, or any other identifiable information, will be anonymized in a database. This information will be stored for five years under the responsibility of the corresponding researchers. The collected data will be published to be used in other studies related to anesthesia and consciousness. All published data will be completely anonymized. It is possible that the obtained results are presented in journals and medical or scientific conferences. However, the name and identifiable data will not be known.
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