Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
360 participants
OBSERVATIONAL
2019-10-31
2020-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In a way, this professional is the controller in a control system that acts on the plant (the patient) through the infusion of hypnotic drugs, analgesics and neuromuscular blockers. In addition, the anesthesiologist estimates the state of consciousness, the level of analgesia and the level of neuromuscular blockage through other indirect measures, as well as a state observer.
There are different techniques for direct monitoring of these three anesthesia variables (DoA, NMB and NoL), such as BIS and Narcotrend, but all have some disadvantages, especially when the anesthesia process combines different drugs. This work proposes a new way of evaluating DoA, NMB and NoL using data fusion techniques to combine classical clinical signs with advanced EEG monitoring techniques to provide a decision support system for the anesthesiologist.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Machine Learning-Based Model for Individualized Drug Dose Prediction for Propofol
NCT06703879
NoL Monitor Performances of Nociceptive and Non-nociceptive Stimuli Discrimination During Robotic Surgery
NCT04566536
Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy
NCT00391885
Detection of Consciousness by EEG and Auditory Evoked Potentials
NCT01720615
AI-Assisted Blood Pressure Control During Anesthesia
NCT07123675
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In addition, the anesthesiologist estimates the the level of consciousness, of nociception and the level of neuromuscular blockade through these indirect measurements, just as a state observer in a control system would do.
There are different techniques for the direct monitoring of these three variables of anesthesia (DoA, NMB and NoL), such as BIS and Narcotrend, but all of them present a few disadvantages and mis-measurements, especially when the anesthesia process combines different drugs.
This work proposes a new way of evaluating DoA, NMB and NoL, using techniques to combine classical clinical signs with advanced EEG monitoring, to provide a decision support system for the anesthesiologist.
For this, we will perform data acquisition from the equipment usually used in surgical procedures with general anesthesia, such as ECG, EEG, blood pressure, mechanical ventilation, among others.
In short, all data of the patient's vital signs during the procedure and the actions taken by the anesthesiologist and surgeons.
The data will be concentrated on a specific equipment, and will be analyzed together with the data of other patients to improve the mathematical models involved in the process.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CROSSOVER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Underweight Adult Male
Male patients with Underweight BMI classification and more than 20 years old https://www.cdc.gov/healthyweight/assessing/bmi/adult\_bmi/index.html
No interventions assigned to this group
Healthy Weight Adult Male
Male patients with Healthy Weight BMI classification and more than 20 years old
No interventions assigned to this group
Overweight Adult Male
Male patients with OverWeight or Obese BMI classification and more than 20 years old
No interventions assigned to this group
Underweight Adult Female
Female patients with Underweight BMI classification and more than 20 years old
No interventions assigned to this group
Healthy Weight Adult Female
Female patients with Healthy Weight BMI classification and more than 20 years old
No interventions assigned to this group
Overweight Adult Female
Female patients with Overweight or Obese BMI classification and more than 20 years old
No interventions assigned to this group
Underweight children Male
Male patients less than 20 year old, and with Underweight BMI classification https://www.cdc.gov/healthyweight/assessing/bmi/childrens\_bmi/about\_childrens\_bmi.html
No interventions assigned to this group
Healthy Weight children Male
Male patients less than 20 year old, and with Healthy Weight BMI classification
No interventions assigned to this group
Overweight children Male
Male patients less than 20 year old, and with Overweight or Obese BMI classification
No interventions assigned to this group
Underweight children Female
Male patients less than 20 year old, and with Underweight BMI classification https://www.cdc.gov/healthyweight/assessing/bmi/childrens\_bmi/about\_childrens\_bmi.html
No interventions assigned to this group
Healthy Weight children Female
Female patients less than 20 year old, and with Overweight or Obese BMI classification
No interventions assigned to this group
Overweight children Female
Female patients less than 20 year old, and with Overweight or Obese BMI classification
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
1 Month
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Sao Paulo
OTHER
Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Joaquim Edson Vieira
Phd Anesthesiology Professor and Principal invesigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joaquim E Vieira, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, , Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Schnider TW, Minto CF, Struys MM, Absalom AR. The Safety of Target-Controlled Infusions. Anesth Analg. 2016 Jan;122(1):79-85. doi: 10.1213/ANE.0000000000001005.
Karl J Åström, Björn Wittenmark. Computer-Controlled Systems: Theory and Design. Dover Books on Electrical Engineering. ISBN: 0486284042. Courier Corporation, 2013
Ahmad AM. Recent advances in pharmacokinetic modeling. Biopharm Drug Dispos. 2007 Apr;28(3):135-43. doi: 10.1002/bdd.540.
Iselin-Chaves IA, Flaishon R, Sebel PS, Howell S, Gan TJ, Sigl J, Ginsberg B, Glass PS. The effect of the interaction of propofol and alfentanil on recall, loss of consciousness, and the Bispectral Index. Anesth Analg. 1998 Oct;87(4):949-55. doi: 10.1097/00000539-199810000-00038.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAAE 03424918.6.0000.0068
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.