Automatic Control of Total Intravenous Anesthesia: Closed-loop Delivery of Propofol and Remifentanil Using Bispectral Index as Feedback Variable
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 139
- Locations
- 2
- Primary Endpoint
- Depth of Hypnosis Adequacy
Study Overview
Brief 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 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients undergoing total intravenous general anesthesia for elective surgery
Exclusion Criteria
- •Patients under the age of 18
- •Patients incapable of giving consent
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Number of Participants for Which the System Showed Dysfunctions(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(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(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)(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(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(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(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(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(End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.)
Investigators
Massimiliano Paltenghi
Principal Investigator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia