Calculated and Graphically Produced Depth of Anesthesia

Study Overview
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Brief Summary
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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.

Official Title
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Computer-assisted Anaesthesia Using Pharmacokinetic/Pharmacodynamic Model

Conditions
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Anesthesia, General

Intervention / Treatment
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* Device: Calculated and graphically produced depth of anesthesia (Smart Pilot® View)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1-3 Standard premedication General anesthesia, total intravenous anesthesia Exclusion Criteria: Alcoholics BMI 35 or higher Unable to give consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart Pilot(R) View<br>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)<br>* 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.<br>|
| No Intervention: Standard<br>Anesthesia provided by standard procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Arterial Pressure (MAP) |  | Maximum 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate (HR) |  | Maximum 5 hours | 
| Bispectral Index (BIS) |  | Maximum 5 hours | 
| Total dosis of Propofol in milligrams |  | Maximum 5 hours | 
| Total dosis of Remifentanil in micrograms |  | Maximum 5 hours | 
| Total dosis of Ephedrine in milligrams |  | Maximum 5 hours | 
| Total dosis of Phenylephrine in micrograms |  | Maximum 5 hours | 
| Total dosis of Atropine in micrograms |  | Maximum 5 hours | 
| Total dosis of Norepinephrine in micrograms |  | Maximum 5 hours | 
| Duration of surgery in minutes |  | Maximum 5 hours | 
| Duration of anesthesia in minutes |  | Maximum 5 hours | 
| Time until extubation in minutes |  | Maximum 5 hours | 
| Duration of stay in postoperative ward in minutes |  | Maximum 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Methods, Anesthesia, Analysis, Patient Safety, Anesthetics/administration and dosage