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Calculated and Graphically Produced Depth of Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03807271
Recruitment Status : Enrolling by invitation
First Posted : January 16, 2019
Last Update Posted : June 19, 2019
Sykehuset Innlandet HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Anesthesia, General Device: Calculated and graphically produced depth of anesthesia (Smart Pilot® View) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The anesthesia team must know if the anesthesia will be given by standard procedure or guided by the calculating device in addition.
Primary Purpose: Prevention
Official Title: Computer-assisted Anaesthesia Using Pharmacokinetic/Pharmacodynamic Model
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: Smart Pilot(R) View
Anesthesia provided by standard procedure, additionally guided by Smart Pilot(R) View, a device with calculated and graphically produced depth of anesthesia.
Device: Calculated and graphically produced depth of anesthesia (Smart Pilot® View)
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.

No Intervention: Standard
Anesthesia provided by standard procedure.

Primary Outcome Measures :
  1. Mean Arterial Pressure (MAP) [ Time Frame: Maximum 5 hours ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03807271

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Anestesiavdeling Lillehammer Sykehus
Lillehammer, Oppland, Norway, 2609
Sponsors and Collaborators
Norwegian University of Science and Technology
Sykehuset Innlandet HF
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Study Director: Heidi Vifladt, MD Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology Identifier: NCT03807271     History of Changes
Other Study ID Numbers: 2018/2176
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Anesthesia, Methods
Anesthesia, Analysis
Patient Safety
Anesthetics/administration and dosage

Additional relevant MeSH terms:
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Central Nervous System Depressants
Physiological Effects of Drugs