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Completed

NCT Number: NCT01467167

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

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.

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Key information

Conditions

Anesthesia,General Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen (UMCG), Groningen, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Anesthesia Quality Score

    Time frame: 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 outcomes

  1. Total anesthetic drug doses

    Time frame: up to 1 week From start of induction until discharge from post-anesthesia care unit (PACU)

  2. Mean intra-operative Noxious Stimulation Response Index (NSRI)

    Time frame: 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.

  3. Number of doses of vasoactive substances

    Time frame: 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.

  4. Number of events with motor and vegetative (tearing, sweating) responses

    Time frame: 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.

  5. Recovery times (skin closure to extubation; skin closure to orientation)

    Time frame: 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.

  6. Early postoperative pain control measured by visual analog scale and total morphine dose

    Time frame: 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.

  7. Workload of anesthesist, measured by the NASA Taskload Index

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Nov 8, 2011
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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