Calculated and Graphically Produced Depth of Anesthesia
|ClinicalTrials.gov Identifier: NCT03807271|
Recruitment Status : Enrolling by invitation
First Posted : January 16, 2019
Last Update Posted : June 19, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||The anesthesia team must know if the anesthesia will be given by standard procedure or guided by the calculating device in addition.|
|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|
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.
- Mean Arterial Pressure (MAP) [ Time Frame: Maximum 5 hours ]
- Heart Rate (HR) [ Time Frame: Maximum 5 hours ]
- Bispectral Index (BIS) [ Time Frame: Maximum 5 hours ]
- Total dosis of Propofol in milligrams [ Time Frame: Maximum 5 hours ]
- Total dosis of Remifentanil in micrograms [ Time Frame: Maximum 5 hours ]
- Total dosis of Ephedrine in milligrams [ Time Frame: Maximum 5 hours ]
- Total dosis of Phenylephrine in micrograms [ Time Frame: Maximum 5 hours ]
- Total dosis of Atropine in micrograms [ Time Frame: Maximum 5 hours ]
- Total dosis of Norepinephrine in micrograms [ Time Frame: Maximum 5 hours ]
- Duration of surgery in minutes [ Time Frame: Maximum 5 hours ]
- Duration of anesthesia in minutes [ Time Frame: Maximum 5 hours ]
- Time until extubation in minutes [ Time Frame: Maximum 5 hours ]
- Duration of stay in postoperative ward in minutes [ Time Frame: Maximum 2 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807271
|Anestesiavdeling Lillehammer Sykehus|
|Lillehammer, Oppland, Norway, 2609|
|Study Director:||Heidi Vifladt, MD||Norwegian University of Science and Technology|