Calculated and Graphically Produced Depth of Anesthesia

Computer-assisted Anaesthesia Using Pharmacokinetic/Pharmacodynamic Model

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, General
• Intervention / Treatment: Device: Calculated and graphically produced depth of anesthesia (Smart Pilot® View)

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oppland
    • Lillehammer, Oppland, Norway, 2609
      • Anestesiavdeling Lillehammer Sykehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Sykehuset Innlandet HF
• Investigators: Study Director: Heidi Vifladt, MD, Norwegian University of Science and Technology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Actual): November 13, 2019
• Study Completion (Actual): November 13, 2019

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 12, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Anesthesia, Methods; Anesthesia, Analysis; Patient Safety; Anesthetics/administration and dosage
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2018/2176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No