Clinical trial NCT03807271: Calculated and Graphically Produced Depth of Anesthesia
Official title: Computer-assisted Anaesthesia Using Pharmacokinetic/Pharmacodynamic Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, General
Keywords: Anesthesia, Methods
Anesthesia, Analysis
Patient Safety
Anesthetics/administration and dosage
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Sykehuset Innlandet HF
First posted: 2019-01-16
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Mean Arterial Pressure (MAP)
timeFrame: Maximum 5 hours
Secondary outcomes:
measure: Heart Rate (HR)
timeFrame: Maximum 5 hours
measure: Bispectral Index (BIS)
timeFrame: Maximum 5 hours
measure: Total dosis of Propofol in milligrams
timeFrame: Maximum 5 hours
measure: Total dosis of Remifentanil in micrograms
timeFrame: Maximum 5 hours
measure: Total dosis of Ephedrine in milligrams
timeFrame: Maximum 5 hours
measure: Total dosis of Phenylephrine in micrograms
timeFrame: Maximum 5 hours
measure: Total dosis of Atropine in micrograms
timeFrame: Maximum 5 hours
measure: Total dosis of Norepinephrine in micrograms
timeFrame: Maximum 5 hours
measure: Duration of surgery in minutes
timeFrame: Maximum 5 hours
measure: Duration of anesthesia in minutes
timeFrame: Maximum 5 hours
measure: Time until extubation in minutes
timeFrame: Maximum 5 hours
measure: Duration of stay in postoperative ward in minutes
timeFrame: Maximum 2 days
Other outcomes:
Locations:
city: Lillehammer
country: Norway
facility: Anestesiavdeling Lillehammer Sykehus
state: Oppland
Study officials:
affiliation: Norwegian University of Science and Technology
name: Heidi Vifladt, MD
role: STUDY_DIRECTOR
References:
citation: Strand H, Elshaug AC, Bernersen O, Ballangrud R. Effectiveness of the advisory display SmartPilot(R) view in the assessment of anesthetic depth in low risk gynecological surgery patients: a randomized controlled trial. BMC Anesthesiol. 2022 Feb 28;22(1):57. doi: 10.1186/s12871-022-01593-w.