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Calculated and Graphically Produced Depth of Anesthesia

Computer-assisted Anaesthesia Using Pharmacokinetic/Pharmacodynamic Model

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03807271
Enrollment
114
Registered
2019-01-16
Start date
2019-01-14
Completion date
2019-11-13
Last updated
2019-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General

Keywords

Anesthesia, Methods, Anesthesia, Analysis, Patient Safety, Anesthetics/administration and dosage

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.

Interventions

DEVICECalculated 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.

Sponsors

Sykehuset Innlandet HF
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

The anesthesia team must know if the anesthesia will be given by standard procedure or guided by the calculating device in addition.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
Mean Arterial Pressure (MAP)Maximum 5 hours

Secondary

MeasureTime frame
Bispectral Index (BIS)Maximum 5 hours
Total dosis of Propofol in milligramsMaximum 5 hours
Total dosis of Remifentanil in microgramsMaximum 5 hours
Total dosis of Ephedrine in milligramsMaximum 5 hours
Total dosis of Phenylephrine in microgramsMaximum 5 hours
Heart Rate (HR)Maximum 5 hours
Total dosis of Norepinephrine in microgramsMaximum 5 hours
Duration of surgery in minutesMaximum 5 hours
Duration of anesthesia in minutesMaximum 5 hours
Time until extubation in minutesMaximum 5 hours
Duration of stay in postoperative ward in minutesMaximum 2 days
Total dosis of Atropine in microgramsMaximum 5 hours

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026