Calculated and Graphically Produced Depth of Anesthesia

Anesthesia, General Clinical Trial

Official title:

Computer-assisted Anaesthesia Using Pharmacokinetic/Pharmacodynamic Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807271
• Other study ID #: 2018/2176
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: November 13, 2019

Study information

• Verified date: December 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: November 13, 2019
• Est. primary completion date: November 13, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• ASA 1-3

• Standard premedication

• General anesthesia, total intravenous anesthesia

Exclusion Criteria:

• Alcoholics

• BMI 35 or higher

• Unable to give consent

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

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.

Locations

Country	Name	City	State
Norway	Anestesiavdeling Lillehammer Sykehus	Lillehammer	Oppland

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Arterial Pressure (MAP)		Maximum 5 hours
Secondary	Heart Rate (HR)		Maximum 5 hours
Secondary	Bispectral Index (BIS)		Maximum 5 hours
Secondary	Total dosis of Propofol in milligrams		Maximum 5 hours
Secondary	Total dosis of Remifentanil in micrograms		Maximum 5 hours
Secondary	Total dosis of Ephedrine in milligrams		Maximum 5 hours
Secondary	Total dosis of Phenylephrine in micrograms		Maximum 5 hours
Secondary	Total dosis of Atropine in micrograms		Maximum 5 hours
Secondary	Total dosis of Norepinephrine in micrograms		Maximum 5 hours
Secondary	Duration of surgery in minutes		Maximum 5 hours
Secondary	Duration of anesthesia in minutes		Maximum 5 hours
Secondary	Time until extubation in minutes		Maximum 5 hours
Secondary	Duration of stay in postoperative ward in minutes		Maximum 2 days