AnesthesiaACTIVANCT04432974
Automatic Control of Total Intravenous Anesthesia (ACTIVA)
A study testing Automatic closed-loop anesthesia in people with Anesthesia, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
This study concerns the clinical evaluation of a closed loop control system for the automatic administration of anesthetic drugs in TIVA (Total Intra Venous Anesthesia). The purpose of the experimentation is to demonstrate that the control system under study is reliable, safe, applicable and capable of inducing and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Automatic closed-loop anesthesia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jul 2019to 4 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing total intravenous general anesthesia for elective surgery
Who cannot join
- Patients under the age of 18
- Patients incapable of giving consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, 25123
About this study
Official title: Automatic Control of Total Intravenous Anesthesia: Closed-loop Delivery of Propofol and Remifentanil Using Bispectral Index as Feedback Variable
This study concerns the clinical evaluation of a closed loop control system for the automatic administration of anesthetic drugs in TIVA (Total Intra Venous Anesthesia).
The purpose of the experimentation is to demonstrate that the control system under study is reliable, safe, applicable and capable of inducing and maintaining an optimal anesthetic level.
Read the detailed description
This clinical study consists of the application of the ACTIVA control software for the infusion of intravenous drugs during general anesthesia according to the principle of closed-loop anesthesia.
The objective of the experimentation is to evaluate the reliability, safety and applicability of the infusion system for anesthetic drugs controlled by the ACTIVA software and to carry out the clinical evaluation of the automatic control system during the induction and maintenance of general intravenous anesthesia. The benefits for enrolled patients could be linked to greater stability of anesthesia in the induction and maintenance phases. Constant closed-loop control of infusions and the level of hypnosis could also reduce the hemodynamic impact that general anesthesia has on the patient, by reducing the onset of hypotension episodes.
Enrolled patients will undergo closed-loop anesthesia under the constant supervision of the investigator. The anesthetic drugs used are those recommended for general intravenous anesthesia: propofol and remifentanil.
Identification and description of the medical device:
The medical device object of the clinical investigation consists of the ACTIVA control software developed to control the infusion of anesthetic drugs during general intravenous anesthesia. ACTIVA software has been developed to optimize the infusion of anesthetic drugs according to a closed-loop system that allows the induction and maintenance of a constant and optimal level of anesthesia on the patient. ACTIVA control software is installed on a personal computer (PC).
The level of anesthesia is measured according to the Bispectral Index (BIS) which measures the depth of hypnosis. Through the measurement of the BIS, the administration of anesthetic drugs is automatically regulated by the ACTIVA software and constantly supervised by the anesthesiologist through the graphic interface integrated in the software.
The population for which the device is intended is made up of patients to undergo surgery for which general anesthesia is required, and intravenous anesthesia may be advantageous.
During its operation, the ACTIVA software maintains the desired BIS level, selected by the anesthesiologist through the graphical user interface, communicating the appropriate infusion rate of the propofol and remifentanil anesthetic drugs to the syringe pumps. ACTIVA software communicates with the pumps and the BIS monitoring system with serial connections. These connections are native to the instrumentation used; therefore, no type of modification or manipulation has been made on the medical devices used.
Closed-loop anesthesia:
A closed-loop system can be defined as an automatic control system that bases its operation on the principle of feedback. Its key elements are a system to be controlled, a measuring device (sensor), a controller and an actuator. The sensor measures the controlled variable (system output), which is compared with the desired set-point. The difference between the latter and the output, defined as an error, is used to calculate the value of the control variable (system input).
In the case of closed-loop anesthesia, the system to be controlled identifies with the patient, the actuator is represented by the syringe pump, the controlled variable corresponds to the BIS and the control variable is represented by the rate of infusion of the drugs.
The controller used is a proportional-integral-derivative (PID) it relates the error signal and the control variable by means of three constants (Kp, Ti and Td) allowing a correct infusion of the drugs considering the present value of the error ( proportional action), the past values of the error (integral action) and the advance of the future values of the error (derivative action). These three constants, if properly calibrated, allow to obtain a controller with good performance and robustness. For the ACTIVA system the calibration of these constants was carried out by means of optimization methods performed in simulation.
The anesthesiologist has at his disposal a PC with a graphical user interface through which he can control the start and end of the drug infusion and on which there are the commands through which it is possible to interact with the system. The graphical interface also reports indicators concerning the correct functioning of the control system. In case of malfunction of the ACTIVA software, the patient monitoring systems are never altered or damaged and the infusive pumps continue to operate in manual mode. Switching to manual control is always possible if the anesthesiologist considers it appropriate, even without the presence of system malfunctions.
- Conditions
- Anesthesia
- Being tested
- Automatic closed-loop anesthesia
- Keywords
- Closed-loop Anesthesia, PID Control, Medical Control Systems, Automated Drug Delivery, Propofol, Remifentanil, Bispectral index, BIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic closed-loop anesthesiaDevice
Also called ACTIVA
Total intravenous anesthesia performed with the ACTIVA automatic control system
| Study group | Role | What they receive |
|---|---|---|
| ACTIVA | Experimental | ACTIVA closed-loop anesthesia control system Receives: Device: Automatic closed-loop anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of Hypnosis Adequacy
The depth of hypnosis adequacy is assessed by evaluating, for each patient enrolled, the percentage of maintenance duration during which the Bispectral Index Scale (BIS) is kept within the recommended range from 40 to 60 (BIS [40,60]).
The outcome measure is defined as the median of these percentages calculated over all the patients enrolled in the study.
The median of the percentages, calculated over all the patients enrolled in the study, of the anesthesia maintenance duration in which the BIS is kept below 40 (BIS<40) is also specified.
Maintenance duration is the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery.
The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds.
The BIS ranges from 0 (absence of brain activity) to 100 (fully awake patient).
Measured: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.
Secondary outcomes (9)
Number of Participants for Which the System Showed Dysfunctions
Number of participants for which the ACTIVA system showed dysfunctions. The results are presented in a table where each row indicates the type of dysfunction and the number of participants for which that particular type of dysfunction occurred.
Measured: During anesthesia from the time instant when the automatic control is started to the point at which the automatic control is turned off at the conclusion of surgery, an average of 2 hours.
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Levels of satisfaction of the experimenter regarding three aspects of the ACTIVA system.
The first aspect is the ease of use of the ACTIVA software and its infusion system.
The second aspect is the behavior of the ACTIVA system during the induction phase of anesthesia.
The third aspect is the behavior of the ACTIVA system during the maintenance phase of anesthesia.
For each aspect, the level of satisfaction is expressed by the experimenter by assigning a score on a scale ranging from 0 (extremely unsatisfied) to 10 (extremely satisfied).
Thus, higher values represent a better outcome. Note that the scoring scale employed is the same for each of the three aspects. The results are reported in a table divided in three rows, one for each aspect evaluated.
Each row is divided in eleven categories representing the scores from 0 to 10. For each category it is indicated the number of patients for which the experimenter expressed that specific score.
Measured: During anesthesia from the time instant when the automatic control is started to the point at which the automatic control is turned off at the conclusion of surgery, an average of 2 hours.
Effect of Drugs Delivery on Heart Rate
The effect of drugs delivery on heart rate is assessed by evaluating, for each patient enrolled, the percentage of the anesthesia maintenance duration in which the heart rate (HR) is kept inside the range from 50 to 100 beats per minute (HR [50,100]).
The outcome measure is defined as the median of these percentages calculated over all the patients enrolled in the study.
The median of the percentages, calculated over all the patients enrolled in the study, of the anesthesia maintenance duration in which the HR is kept below 50 (HR<50) is also specified.
Maintenance duration is the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery.
The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds.
Measured: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.
Effect of Drugs Delivery on Mean Arterial Pressure (MAP)
The effect of drugs delivery on mean arterial pressure (MAP) is assessed by evaluating, for each patient enrolled, the anesthesia maintenance duration in which the non-invasively measured MAP is kept inside the range from 65 to 110 mmHg (MAP [65,110]).
The outcome measure is defined as the median of these percentages calculated over all the patients enrolled in the study.
The median of the percentages, calculated over all the patients enrolled in the study, of the anesthesia maintenance duration in which the MAP is kept below 65 (MAP<65) is also specified.
Maintenance duration is the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery.
The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds.
MAP is defined as diastolic pressure + 1/3(systolic pressure - diastolic pressure).
Measured: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.
Postoperative Heart Rate Stability
The postoperative heart rate is assessed by measuring the heart rate in beats per minute (bpm).
Measured: End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.
Postoperative Mean Arterial Pressure (MAP) Stability
The postoperative mean arterial pressure (MAP) stability is assessed by non-invasively measuring the MAP with an electronic sphygmomanometer trough an inflatable cuff.
Mean arterial pressure (MAP) is defined as diastolic pressure + 1/3(systolic pressure - diastolic pressure).
Measured: End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
The postoperative sedation is assessed by means of a Sedation Score scale. It is a 3 point scale from 0 (fully awake) to 3 (fully sedated)
Measured: End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
Postoperative Nausea and Vomiting is assessed by means of the Bellville PONV scale. It is a 3 point scale from 0 (no nausea \& vomiting) to 3 (vomiting present)
Measured: End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
The postoperative analgesia is assessed using a 10-point numeric rating scale (NRS). It is a 10 point scale from 0 (no pain) to 10 (maximum pain).
Measured: End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start2 Jul 2019
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Brescia
- Responsible party
- Principal investigator, Massimiliano Paltenghi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Massimiliano Paltenghi, MD, Principal investigator, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432974
- Sponsor's protocol ID
- NP-2861
- Acronym
- ACTIVA
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2020
- Last updated
- 4 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Padula F, Ionescu C, Latronico N, Paltenghi M, Visioli A, Vivacqua G. Optimized PID control of depth of hypnosis in anesthesia. Comput Methods Programs Biomed. 2017 Jun;144:21-35. doi: 10.1016/j.cmpb.2017.03.013. Epub 2017 Mar 18.
PubMed 28495004Merigo L, Beschi M, Padula F, Latronico N, Paltenghi M, Visioli A. Event-Based control of depth of hypnosis in anesthesia. Comput Methods Programs Biomed. 2017 Aug;147:63-83. doi: 10.1016/j.cmpb.2017.06.007. Epub 2017 Jun 23.
PubMed 28734531Schiavo M, Paltenghi M, Visioli A, Latronico N. Clinical Performance of a Bispectral Index Controlled Closed-Loop Administration System for Simultaneous Administration of Propofol and Remifentanil. Anesth Analg. 2025 May 1;140(5):1236-1238. doi: 10.1213/ANE.0000000000007289. No abstract available.
PubMed 39413036
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Control of Total Intravenous Anesthesia: Closed-loop Delivery of Propofol and Remifentanil Using Bispectral Index as Feedback Variable
- ClinicalTrials.gov ID
- NCT04432974
- Acronym / sponsor ID
- ACTIVA / NP-2861
- Conditions
- Anesthesia
- Keywords
- Closed-loop Anesthesia, PID Control, Medical Control Systems, Automated Drug Delivery, Propofol, Remifentanil, Bispectral index, BIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Collaborators
- Università degli Studi di Brescia
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Posted 4 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study concerns the clinical evaluation of a closed loop control system for the automatic administration of anesthetic drugs in TIVA (Total Intra Venous Anesthesia).
The purpose of the experimentation is to demonstrate that the control system under study is reliable, safe, applicable and capable of inducing and maintaining an optimal anesthetic level.
Detailed description
This clinical study consists of the application of the ACTIVA control software for the infusion of intravenous drugs during general anesthesia according to the principle of closed-loop anesthesia.
The objective of the experimentation is to evaluate the reliability, safety and applicability of the infusion system for anesthetic drugs controlled by the ACTIVA software and to carry out the clinical evaluation of the automatic control system during the induction and maintenance of general intravenous anesthesia. The benefits for enrolled patients could be linked to greater stability of anesthesia in the induction and maintenance phases. Constant closed-loop control of infusions and the level of hypnosis could also reduce the hemodynamic impact that general anesthesia has on the patient, by reducing the onset of hypotension episodes.
Enrolled patients will undergo closed-loop anesthesia under the constant supervision of the investigator. The anesthetic drugs used are those recommended for general intravenous anesthesia: propofol and remifentanil.
Identification and description of the medical device:
The medical device object of the clinical investigation consists of the ACTIVA control software developed to control the infusion of anesthetic drugs during general intravenous anesthesia. ACTIVA software has been developed to optimize the infusion of anesthetic drugs according to a closed-loop system that allows the induction and maintenance of a constant and optimal level of anesthesia on the patient. ACTIVA control software is installed on a personal computer (PC).
The level of anesthesia is measured according to the Bispectral Index (BIS) which measures the depth of hypnosis. Through the measurement of the BIS, the administration of anesthetic drugs is automatically regulated by the ACTIVA software and constantly supervised by the anesthesiologist through the graphic interface integrated in the software.
The population for which the device is intended is made up of patients to undergo surgery for which general anesthesia is required, and intravenous anesthesia may be advantageous.
During its operation, the ACTIVA software maintains the desired BIS level, selected by the anesthesiologist through the graphical user interface, communicating the appropriate infusion rate of the propofol and remifentanil anesthetic drugs to the syringe pumps. ACTIVA software communicates with the pumps and the BIS monitoring system with serial connections. These connections are native to the instrumentation used; therefore, no type of modification or manipulation has been made on the medical devices used.
Closed-loop anesthesia:
A closed-loop system can be defined as an automatic control system that bases its operation on the principle of feedback. Its key elements are a system to be controlled, a measuring device (sensor), a controller and an actuator. The sensor measures the controlled variable (system output), which is compared with the desired set-point. The difference between the latter and the output, defined as an error, is used to calculate the value of the control variable (system input).
In the case of closed-loop anesthesia, the system to be controlled identifies with the patient, the actuator is represented by the syringe pump, the controlled variable corresponds to the BIS and the control variable is represented by the rate of infusion of the drugs.
The controller used is a proportional-integral-derivative (PID) it relates the error signal and the control variable by means of three constants (Kp, Ti and Td) allowing a correct infusion of the drugs considering the present value of the error ( proportional action), the past values of the error (integral action) and the advance of the future values of the error (derivative action). These three constants, if properly calibrated, allow to obtain a controller with good performance and robustness. For the ACTIVA system the calibration of these constants was carried out by means of optimization methods performed in simulation.
The anesthesiologist has at his disposal a PC with a graphical user interface through which he can control the start and end of the drug infusion and on which there are the commands through which it is possible to interact with the system. The graphical interface also reports indicators concerning the correct functioning of the control system. In case of malfunction of the ACTIVA software, the patient monitoring systems are never altered or damaged and the infusive pumps continue to operate in manual mode. Switching to manual control is always possible if the anesthesiologist considers it appropriate, even without the presence of system malfunctions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACTIVA | Experimental | Device: Automatic closed-loop anesthesiaACTIVA closed-loop anesthesia control system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing total intravenous general anesthesia for elective surgery
Key exclusion criteria (2 listed)
- Patients under the age of 18
- Patients incapable of giving consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic closed-loop anesthesiaAlso: ACTIVATotal intravenous anesthesia performed with the ACTIVA automatic control system | Device | ACTIVA |
Primary outcome
Depth of Hypnosis Adequacy
Time frame: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.
The depth of hypnosis adequacy is assessed by evaluating, for each patient enrolled, the percentage of maintenance duration during which the Bispectral Index Scale (BIS) is kept within the recommended range from 40 to 60 (BIS [40,60]). The outcome measure is defined as the median of these percentages calculated over all the patients enrolled in the study. The median of the percentages, calculated over all the patients enrolled in the study, of the anesthesia maintenance duration in which the BIS is kept below 40 (BIS<40) is also specified. Maintenance duration is the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery. The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds. The BIS ranges from 0 (absence of brain activity) to 100 (fully awake patient).
9 secondary outcomes
Number of Participants for Which the System Showed Dysfunctions
Time frame: During anesthesia from the time instant when the automatic control is started to the point at which the automatic control is turned off at the conclusion of surgery, an average of 2 hours.
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Time frame: During anesthesia from the time instant when the automatic control is started to the point at which the automatic control is turned off at the conclusion of surgery, an average of 2 hours.
Effect of Drugs Delivery on Heart Rate
Time frame: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.
Effect of Drugs Delivery on Mean Arterial Pressure (MAP)
Time frame: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.
Postoperative Heart Rate Stability
Time frame: End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.
Postoperative Mean Arterial Pressure (MAP) Stability
Time frame: End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
Time frame: End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
Time frame: End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Time frame: End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28495004Padula F, Ionescu C, Latronico N, Paltenghi M, Visioli A, Vivacqua G. Optimized PID control of depth of hypnosis in anesthesia. Comput Methods Programs Biomed. 2017 Jun;144:21-35. doi: 10.1016/j.cmpb.2017.03.013. Epub 2017 Mar 18.
- Background: PubMed 28734531Merigo L, Beschi M, Padula F, Latronico N, Paltenghi M, Visioli A. Event-Based control of depth of hypnosis in anesthesia. Comput Methods Programs Biomed. 2017 Aug;147:63-83. doi: 10.1016/j.cmpb.2017.06.007. Epub 2017 Jun 23.
- Derived from this study: PubMed 39413036Schiavo M, Paltenghi M, Visioli A, Latronico N. Clinical Performance of a Bispectral Index Controlled Closed-Loop Administration System for Simultaneous Administration of Propofol and Remifentanil. Anesth Analg. 2025 May 1;140(5):1236-1238. doi: 10.1213/ANE.0000000000007289. No abstract available.
- Individual participant dataSharing planned: No
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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.
Massimiliano Paltenghi, MD principal investigator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic closed-loop anesthesia in people with Anesthesia, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
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 2 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: finished, as of the sponsor's last update on 4 Oct 2024. 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 Italy. 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?
Yes. Results are posted in the registry (first posted 4 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depth of Hypnosis Adequacy (time frame: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.). 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 NCT04432974, which also lists 3 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 4 Oct 2024.