Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study

Study Overview
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Brief Summary
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Recently, a new software program for anesthesia has been developed, called Smart Pilot View. This program monitors the patient, the anesthetic drugs given, and the calculated depth of the anesthesia. The purpose of this study is to determine whether the use of this program improves the quality of anesthesia.

Official Title
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Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study

Conditions
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Anesthesia,General

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective surgery General anesthesia American Society of Anesthesiologists Physical Status: I - III Age 18 to 90 years Exclusion Criteria: Combined regional and general anesthesia Expected surgery duration < 30 minutes Central nervous system (CNS) diseases (dementia, cerebrovascular accident, seizures, psychiatric diseases) Regular intake of CNS active drugs (benzodiazepines, antidepressants, antipsychotics, anticonvulsants) Heart surgery on cardio-pulmonary bypass Relevant hepatic disease (Child B or higher) BMI >35 Overt signs of alcohol abuse Contraindications or allergies to drugs used in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Baseline<br>Baseline group in which patients are anesthetized without the use of Smart Pilot View, according to common practice. | |
| Smart Pilot View Group<br>Study group in which patients are anesthetized with the use of Smart Pilot View. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthesia Quality Score | Anesthesia Quality Score (AQS) is defined as the percentage of time the BIS is within the range of 40-60 AND the mean arterial pressure is within the range of 60-80 mmHg. | up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total anesthetic drug doses |  | up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU) | 
| Mean intra-operative Noxious Stimulation Response Index (NSRI) | The Noxious Stimulation Response Index (NSRI) is based on a hierarchical interaction propofol-remifentanil model. With this model, the predicted propofol and remifentanyl concentrations can make a prediction about a respons to a certain stimulus, such as shaking and shouting, or a noxious stimulus. | 1 day During surgery (until skin closure) | 
| Number of doses of vasoactive substances | The number of doses of vasoactive substances given to maintain an adequate perfusion pressure. | up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU) | 
| Number of events with motor and vegetative (tearing, sweating) responses | The total number of events in which the patient displays vegetative reactions such as tearing and sweating, in respons to a noxious stimulus during surgery. | up to 1 week From start of induction until discharge from post-anesthesia care unit | 
| Recovery times (skin closure to extubation; skin closure to orientation) | The time it takes for the patient to recover from anesthesia: the time from skin closure until the patient is sufficiently awake to be extubated, and the time from skin closure until full orientation of the patient. | up to 1 week From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU) | 
| Early postoperative pain control measured by visual analog scale and total morphine dose | Assess the adequacy of pain control during the early postoperative stage, measured by the visual analog scale and the total dose of morphine immediately postoperatively and during PACU stay. | up to 1 day From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU) | 
| Workload of anesthesist, measured by the NASA Taskload Index | Assess the workload the anesthetist experiences while working with the Smart Pilot View | up to 1 day From start of induction until transportation to PACU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Smart Pilot View, Pain control, Recovery