Clinical trial NCT01467167: Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study
Official title: Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia,General
Keywords: Anesthesia
Smart Pilot View
Pain control
Recovery
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2011-11-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery under general anesthesia scheduled for neurosurgery, gynecology and ear nose and throat surgery.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Anesthesia Quality Score
timeFrame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)
Secondary outcomes:
measure: Total anesthetic drug doses
timeFrame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)
measure: Mean intra-operative Noxious Stimulation Response Index (NSRI)
timeFrame: 1 day During surgery (until skin closure)
measure: Number of doses of vasoactive substances
timeFrame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)
measure: Number of events with motor and vegetative (tearing, sweating) responses
timeFrame: up to 1 week From start of induction until discharge from post-anesthesia care unit
measure: Recovery times (skin closure to extubation; skin closure to orientation)
timeFrame: up to 1 week From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU)
measure: Early postoperative pain control measured by visual analog scale and total morphine dose
timeFrame: up to 1 day From end of surgery (skin closure) until discharge from post-anesthesia care unit (PACU)
measure: Workload of anesthesist, measured by the NASA Taskload Index
timeFrame: up to 1 day From start of induction until transportation to PACU
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen (UMCG)
city: Bern
country: Switzerland
facility: University Hospital of Bern
Study officials:
References:
citation: Kuizenga MH, Vereecke HEM, Absalom AR, Bucher CH, Hannivoort LN, van den Berg JP, Schmalz L, Struys MMRF, Luginbuhl M. Utility of the SmartPilot(R) View advisory screen to improve anaesthetic drug titration and postoperative outcomes in clinical practice: a two-centre prospective observational trial. Br J Anaesth. 2022 Jun;128(6):959-970. doi: 10.1016/j.bja.2022.02.033. Epub 2022 Mar 28.