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OpenTrials
Completed

NCT Number: NCT03807271

Calculated and Graphically Produced Depth of Anesthesia

There are studies that suggest that unsatisfying levels of anesthesia can cause peri- and postoperative complications in the patient undergoing surgery. Having a unnecessary "deep" anesthesia level can be harmful, causing acute renal failure, injure to myocard, cause delirium and increase the mortality rate. Being too "light", on the other hand, can make the patient experience awareness when muscle relaxant is used. This can lead to serious psychological struggles.

Evaluating the depth of anesthesia is the most important task of the anesthesia team, but can be difficult because clinical signs depend on many factors. In addition to clinical evaluation, EEG is commonly used for interpreting the level of anesthesia in todays practice. Unfortunately, this method is not always accurate and has a delay.

New devices are now developed to calculate the anesthesia level based on the drugs given. The level is simultaneously presented graphically on screen. The purpose of this study is to investigate and compare clinical parameters within patients undergoing general anesthesia, with and without the use of such devices. Hemodynamic stability, less use of adrenergics, higher EEG-levels, a more rapid wake-up and shorter time in post operative care can indicate a more precise level of anesthesia, hence, promote patient safety.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Anestesiavdeling Lillehammer Sykehus

Lillehammer, Oppland, 2609, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA 1-3
  • Standard premedication
  • General anesthesia, total intravenous anesthesia

Exclusion criteria

  • Alcoholics
  • BMI 35 or higher
  • Unable to give consent

Treatment and study plan

Calculated and graphically produced depth of anesthesia (Smart Pilot® View)

Device

Smart Pilot® View is a device integrated in the ventilator used under general anesthesia. The depth of anesthesia is calculated based on age, weight, height and the medication given - both volatiles and intravenous. The device does not control the supply of medication directly, but provides an estimate of anesthesia depth that can help the anesthesia team to control the supply of anesthetic agents under general anesthesia, ie indirectly.

Primary outcomes

  1. Mean Arterial Pressure (MAP)

    Time frame: Maximum 5 hours

Secondary outcomes

  1. Heart Rate (HR)

    Time frame: Maximum 5 hours

  2. Bispectral Index (BIS)

    Time frame: Maximum 5 hours

  3. Total dosis of Propofol in milligrams

    Time frame: Maximum 5 hours

  4. Total dosis of Remifentanil in micrograms

    Time frame: Maximum 5 hours

  5. Total dosis of Ephedrine in milligrams

    Time frame: Maximum 5 hours

  6. Total dosis of Phenylephrine in micrograms

    Time frame: Maximum 5 hours

  7. Total dosis of Atropine in micrograms

    Time frame: Maximum 5 hours

  8. Total dosis of Norepinephrine in micrograms

    Time frame: Maximum 5 hours

  9. Duration of surgery in minutes

    Time frame: Maximum 5 hours

  10. Duration of anesthesia in minutes

    Time frame: Maximum 5 hours

  11. Time until extubation in minutes

    Time frame: Maximum 5 hours

  12. Duration of stay in postoperative ward in minutes

    Time frame: Maximum 2 days

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Sykehuset Innlandet HF

Registry information

Official study title

Computer-assisted Anaesthesia Using Pharmacokinetic/Pharmacodynamic Model

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2019
Registry last updated
Dec 11, 2019

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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