AnesthesiaSerenityNCT04079036
Decision Support System for Anesthetists
An observational study of Anesthesia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The balanced anesthesia process contains three main parts: the control of hypnosis, analgesia, and neuromuscular blockade. For the induction phase, the anesthesiologist performs protocols based on prior planning specific to each patient and usually performs these controls by monitoring the classic vital signs and… Read more about this study
- Who is it for?
- Ages 1 month to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- How many people
- 360 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2019to Jan 2020
- How long will I take part?
- 20 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients undergoing surgical procedures with general anesthesia
Who may be able to join
- Patients under general anesthesia
Who cannot join
- Cerebral Palsy patients
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 01246-903
About this study
Official title: Decision Support System for Anesthetists for In-room Monitoring of the Level of Consciousness, Neuro-muscular Blocking and Nociception Employing Data Fusion and Artificial Intelligence
The balanced anesthesia process contains three main parts: the control of hypnosis, analgesia, and neuromuscular blockade. For the induction phase, the anesthesiologist performs protocols based on prior planning specific to each patient and usually performs these controls by monitoring the classic vital signs and other clinical signs for the maintenance phase.
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.
Read the detailed description
The balanced anesthesia process contains three main parts: the control of hypnosis, the analgesia and neuromuscular blockade. For the induction phase, the anesthesiologist performs protocols based on prior planning specific to each patient. Normally, the anesthesiologist controls the process by monitoring the classical vital signs and other clinical most common signs during the maintenance phase. In a way, this professional is the controller in a control system that acts on the plant (the patient) through the infusion of hypnotic and analgesic drugs and neuromuscular blockers.
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
- Anesthesia
- Keywords
- General Anesthesia, Anesthesia Awareness, Anesthesia overdose
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | |
| Healthy Weight Adult Male | Male patients with Healthy Weight BMI classification and more than 20 years old | |
| Overweight Adult Male | Male patients with OverWeight or Obese BMI classification and more than 20 years old | |
| Underweight Adult Female | Female patients with Underweight BMI classification and more than 20 years old | |
| Healthy Weight Adult Female | Female patients with Healthy Weight BMI classification and more than 20 years old | |
| Overweight Adult Female | Female patients with Overweight or Obese BMI classification and more than 20 years old | |
| 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 | |
| Healthy Weight children Male | Male patients less than 20 year old, and with Healthy Weight BMI classification | |
| Overweight children Male | Male patients less than 20 year old, and with Overweight or Obese BMI classification | |
| 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 | |
| Healthy Weight children Female | Female patients less than 20 year old, and with Overweight or Obese BMI classification | |
| Overweight children Female | Female patients less than 20 year old, and with Overweight or Obese BMI classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
HR - Heart Rate - unit: [bpm], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Arterial blood pressure
P_INV - Invasive blood pressure - unit: [mmHg], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Mean Arterial Pressure
MAP - Mean Arterial Pressure - unit: [mmHg], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Non Invasive Blood pressure
P_NINV - Non Invasive blood pressure - unit: [mmHg/mmHg], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Conscience Level
CL - Consciousnesses Level (through BIS) - unit: [u 0-100] will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of diferent surgical procedures
Inspired anesthetic concentration
FiAA - Inspired fraction of anesthetic agent - unit: [% of Volume], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Inspired carbon dioxide concentration
FiCO2 - CO2 inspired Fraction - unit: [% of Volume], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Inspired Nitrous Oxide concentration
FiN2O - N2O inspired Fraction - unit: [% of Volume], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Blood oxygen saturation
SpO2 - Peripheral capillary oxygen saturation - unit: [%], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Exhaled Carbon Dioxide concentration
EtCO2 - End-tidal CO2 concentration (CO2 Exhaled Fraction) - unit: [% of Volume], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Exhaled Anesthetic concentration
EtAA - Anesthetic agents Exhaled Fraction - unit: [% of Volume], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Anesthetic agent infusion rate
IR_Anes - Infusion Rate of anesthetic agent - unit: [mg/hr], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Analgesic agent infusion rate
IR_Analg - Infusion rate of Analgesic agent - unit: [mg/hr], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Neuro-muscular Block agent infusion rate
IR_NMB - Infusion rate of neuro-muscular block agent - unit: [mg/hr], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Ventilation respiratory rate
RR - Respiratory Rate - unit: [bpm], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Ventilation Tidal volume
Vt - Tidal Volume - unit: [mL], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Ventilation Minute Volume
Vm - Minute Volume - unit: [L/min], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Ventilation maximum pressure per cycle
Pmax - Maximum pressure during the inspiration cycle - unit: [cmH2O], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Ventilation Plateau pressure
Pplateau - Plateau pressure during the inspiration cycle - unit: [cmH2O], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Ventilation PEEP
PEEP - Positive end of expiration pressure - unit: [cmH2O], will be stored in real time during the surgical procedure.
Measured: 2 to 3 months of different surgical procedures
Primary anesthesia Data - related to the manual infusion of drugs
Every monitored clinical variable, related to the manual infusion of drugs, will be stored in real time during the surgical procedure.
Every infusion made manually by the anesthesiologist during the procedure should be recorded, always considering the total amount infused and the time it occurred.
Measured: 2 to 3 months of different surgical procedures
Preoperative patient medical records - General state of the patient in ASA.
Anesthesia related preoperative information from the patient, such as prior use of opioids, ASA and METS indexes.
ASA - Physical state of the patient - unit: [u] P1 to P5
Measured: 2 to 3 months of different surgical procedures
Preoperative patient medical records - General state of the patient in METS.
Anesthesia related preoperative information from the patient, such as prior use of opioids, ASA and METS indexes.
METS - Functional state of the patient - unit: [u]
Measured: 2 to 3 months of different surgical procedures
Preoperative patient medical records - Clinical state of the patient - Age
Anesthesia related preoperative information from the patient, such as:
I - Age - unit: [years]
Measured: 2 to 3 months of different surgical procedures
Preoperative patient medical records - Clinical state of the patient - gender
Anesthesia related preoperative information from the patient, such as:
G - Gender - unit: Male or Female
Measured: 2 to 3 months of different surgical procedures
Preoperative patient medical records - Clinical state of the patient - Weight
Anesthesia related preoperative information from the patient, such as:
P - Weight - unit: [Kg]
Measured: 2 to 3 months of different surgical procedures
Preoperative patient medical records - Clinical state of the patient - Height
Anesthesia related preoperative information from the patient, such as:
A - Height - unit: [cm]
Measured: 2 to 3 months of different surgical procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study startOct 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
- Target duration
- 20 Days
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Joaquim Edson Vieira, University of Sao Paulo General Hospital
- Investigators
- Joaquim E Vieira, MD, PhD, Principal investigator, University of Sao Paulo School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079036
- Sponsor's protocol ID
- CAAE 03424918.6.0000.0068
- Acronym
- Serenity
- Status last verified
- Sep 2019
- First submitted
- 10 Jul 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26516801Karl 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.
PubMed 17295411Iselin-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.
PubMed 9768800
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Support System for Anesthetists for In-room Monitoring of the Level of Consciousness, Neuro-muscular Blocking and Nociception Employing Data Fusion and Artificial Intelligence
- ClinicalTrials.gov ID
- NCT04079036
- Acronym / sponsor ID
- Serenity / CAAE 03424918.6.0000.0068
- Conditions
- Anesthesia
- Keywords
- General Anesthesia, Anesthesia Awareness, Anesthesia overdose
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Oct 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The balanced anesthesia process contains three main parts: the control of hypnosis, analgesia, and neuromuscular blockade. For the induction phase, the anesthesiologist performs protocols based on prior planning specific to each patient and usually performs these controls by monitoring the classic vital signs and other clinical signs for the maintenance phase.
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.
Detailed description
The balanced anesthesia process contains three main parts: the control of hypnosis, the analgesia and neuromuscular blockade. For the induction phase, the anesthesiologist performs protocols based on prior planning specific to each patient. Normally, the anesthesiologist controls the process by monitoring the classical vital signs and other clinical most common signs during the maintenance phase. In a way, this professional is the controller in a control system that acts on the plant (the patient) through the infusion of hypnotic and analgesic drugs and neuromuscular blockers.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 20 Days
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| 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 |
| Healthy Weight Adult Male | – | –Male patients with Healthy Weight BMI classification and more than 20 years old |
| Overweight Adult Male | – | –Male patients with OverWeight or Obese BMI classification and more than 20 years old |
| Underweight Adult Female | – | –Female patients with Underweight BMI classification and more than 20 years old |
| Healthy Weight Adult Female | – | –Female patients with Healthy Weight BMI classification and more than 20 years old |
| Overweight Adult Female | – | –Female patients with Overweight or Obese BMI classification and more than 20 years old |
| 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 |
| Healthy Weight children Male | – | –Male patients less than 20 year old, and with Healthy Weight BMI classification |
| Overweight children Male | – | –Male patients less than 20 year old, and with Overweight or Obese BMI classification |
| 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 |
| Healthy Weight children Female | – | –Female patients less than 20 year old, and with Overweight or Obese BMI classification |
| Overweight children Female | – | –Female patients less than 20 year old, and with Overweight or Obese BMI classification |
Who may qualify
- Ages
- 1 month to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing surgical procedures with general anesthesia
Key inclusion criteria (1 listed)
- Patients under general anesthesia
Key exclusion criteria (1 listed)
- Cerebral Palsy patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart Rate
Time frame: 2 to 3 months of different surgical procedures
HR - Heart Rate - unit: [bpm], will be stored in real time during the surgical procedure.
Arterial blood pressure
Time frame: 2 to 3 months of different surgical procedures
P_INV - Invasive blood pressure - unit: [mmHg], will be stored in real time during the surgical procedure.
Mean Arterial Pressure
Time frame: 2 to 3 months of different surgical procedures
MAP - Mean Arterial Pressure - unit: [mmHg], will be stored in real time during the surgical procedure.
Non Invasive Blood pressure
Time frame: 2 to 3 months of different surgical procedures
P_NINV - Non Invasive blood pressure - unit: [mmHg/mmHg], will be stored in real time during the surgical procedure.
Conscience Level
Time frame: 2 to 3 months of diferent surgical procedures
CL - Consciousnesses Level (through BIS) - unit: [u 0-100] will be stored in real time during the surgical procedure.
Inspired anesthetic concentration
Time frame: 2 to 3 months of different surgical procedures
FiAA - Inspired fraction of anesthetic agent - unit: [% of Volume], will be stored in real time during the surgical procedure.
Inspired carbon dioxide concentration
Time frame: 2 to 3 months of different surgical procedures
FiCO2 - CO2 inspired Fraction - unit: [% of Volume], will be stored in real time during the surgical procedure.
Inspired Nitrous Oxide concentration
Time frame: 2 to 3 months of different surgical procedures
FiN2O - N2O inspired Fraction - unit: [% of Volume], will be stored in real time during the surgical procedure.
Blood oxygen saturation
Time frame: 2 to 3 months of different surgical procedures
SpO2 - Peripheral capillary oxygen saturation - unit: [%], will be stored in real time during the surgical procedure.
Exhaled Carbon Dioxide concentration
Time frame: 2 to 3 months of different surgical procedures
EtCO2 - End-tidal CO2 concentration (CO2 Exhaled Fraction) - unit: [% of Volume], will be stored in real time during the surgical procedure.
Exhaled Anesthetic concentration
Time frame: 2 to 3 months of different surgical procedures
EtAA - Anesthetic agents Exhaled Fraction - unit: [% of Volume], will be stored in real time during the surgical procedure.
Anesthetic agent infusion rate
Time frame: 2 to 3 months of different surgical procedures
IR_Anes - Infusion Rate of anesthetic agent - unit: [mg/hr], will be stored in real time during the surgical procedure.
Analgesic agent infusion rate
Time frame: 2 to 3 months of different surgical procedures
IR_Analg - Infusion rate of Analgesic agent - unit: [mg/hr], will be stored in real time during the surgical procedure.
Neuro-muscular Block agent infusion rate
Time frame: 2 to 3 months of different surgical procedures
IR_NMB - Infusion rate of neuro-muscular block agent - unit: [mg/hr], will be stored in real time during the surgical procedure.
Ventilation respiratory rate
Time frame: 2 to 3 months of different surgical procedures
RR - Respiratory Rate - unit: [bpm], will be stored in real time during the surgical procedure.
Ventilation Tidal volume
Time frame: 2 to 3 months of different surgical procedures
Vt - Tidal Volume - unit: [mL], will be stored in real time during the surgical procedure.
Ventilation Minute Volume
Time frame: 2 to 3 months of different surgical procedures
Vm - Minute Volume - unit: [L/min], will be stored in real time during the surgical procedure.
Ventilation maximum pressure per cycle
Time frame: 2 to 3 months of different surgical procedures
Pmax - Maximum pressure during the inspiration cycle - unit: [cmH2O], will be stored in real time during the surgical procedure.
Ventilation Plateau pressure
Time frame: 2 to 3 months of different surgical procedures
Pplateau - Plateau pressure during the inspiration cycle - unit: [cmH2O], will be stored in real time during the surgical procedure.
Ventilation PEEP
Time frame: 2 to 3 months of different surgical procedures
PEEP - Positive end of expiration pressure - unit: [cmH2O], will be stored in real time during the surgical procedure.
Primary anesthesia Data - related to the manual infusion of drugs
Time frame: 2 to 3 months of different surgical procedures
Every monitored clinical variable, related to the manual infusion of drugs, will be stored in real time during the surgical procedure. Every infusion made manually by the anesthesiologist during the procedure should be recorded, always considering the total amount infused and the time it occurred.
Preoperative patient medical records - General state of the patient in ASA.
Time frame: 2 to 3 months of different surgical procedures
Anesthesia related preoperative information from the patient, such as prior use of opioids, ASA and METS indexes. ASA - Physical state of the patient - unit: [u] P1 to P5
Preoperative patient medical records - General state of the patient in METS.
Time frame: 2 to 3 months of different surgical procedures
Anesthesia related preoperative information from the patient, such as prior use of opioids, ASA and METS indexes. METS - Functional state of the patient - unit: [u]
Preoperative patient medical records - Clinical state of the patient - Age
Time frame: 2 to 3 months of different surgical procedures
Anesthesia related preoperative information from the patient, such as: I - Age - unit: [years]
Preoperative patient medical records - Clinical state of the patient - gender
Time frame: 2 to 3 months of different surgical procedures
Anesthesia related preoperative information from the patient, such as: G - Gender - unit: Male or Female
Preoperative patient medical records - Clinical state of the patient - Weight
Time frame: 2 to 3 months of different surgical procedures
Anesthesia related preoperative information from the patient, such as: P - Weight - unit: [Kg]
Preoperative patient medical records - Clinical state of the patient - Height
Time frame: 2 to 3 months of different surgical procedures
Anesthesia related preoperative information from the patient, such as: A - Height - unit: [cm]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Background: PubMed 26516801Schnider 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.
- BackgroundKarl J Åström, Björn Wittenmark. Computer-Controlled Systems: Theory and Design. Dover Books on Electrical Engineering. ISBN: 0486284042. Courier Corporation, 2013
- Results publication: PubMed 17295411Ahmad AM. Recent advances in pharmacokinetic modeling. Biopharm Drug Dispos. 2007 Apr;28(3):135-43. doi: 10.1002/bdd.540.
- Results publication: PubMed 9768800Iselin-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joaquim E Vieira, MD, PhD principal investigator
University of Sao Paulo School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno B Turrin, Msc (+5511998745879, bbturrin@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: 2 to 3 months of different surgical procedures). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04079036, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019; AzTrials last refreshed its copy on 27 Oct 2026.