Anesthesia,General
Conditions
Keywords
Anesthesia, Smart Pilot View, Pain control, Recovery
Brief summary
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.
Interventions
None listed
Sponsors
University Medical Center Groningen
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anesthesia Quality Score | up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total anesthetic drug doses | up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU) | — |
| Number of doses of vasoactive substances | up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU) | The number of doses of vasoactive substances given to maintain an adequate perfusion pressure. |
| Number of events with motor and vegetative (tearing, sweating) responses | up to 1 week From start of induction until discharge from post-anesthesia care unit | 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. |
| Mean intra-operative Noxious Stimulation Response Index (NSRI) | 1 day During surgery (until skin closure) | 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. |
| Early postoperative pain control measured by visual analog scale and total morphine dose | up to 1 day From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU) | 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. |
| Workload of anesthesist, measured by the NASA Taskload Index | up to 1 day From start of induction until transportation to PACU | Assess the workload the anesthetist experiences while working with the Smart Pilot View |
| Recovery times (skin closure to extubation; skin closure to orientation) | up to 1 week From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU) | 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. |
Countries
Netherlands, Switzerland
Outcome results
None listed