Calculated and Graphically Produced Depth of Anesthesia

Norwegian University of Science and Technology

Status: Completed

Conditions: Anesthesia, General

Treatments: Device: Calculated and graphically produced depth of anesthesia (Smart Pilot® View)

Study type: Interventional

Funder types: Other

Identifiers

NCT03807271

2018/2176

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 2 patient groups

Smart Pilot(R) View

Experimental group

Description:

Anesthesia provided by standard procedure, additionally guided by Smart Pilot(R) View, a device with calculated and graphically produced depth of anesthesia.

Treatment:

Device: Calculated and graphically produced depth of anesthesia (Smart Pilot® View)

Standard

No Intervention group

Description:

Anesthesia provided by standard procedure.