Calculated and Graphically Produced Depth of Anesthesia

Not Applicable

Completed

• Conditions: Anesthesia, General
• Interventions: Device: Calculated and graphically produced depth of anesthesia (Smart Pilot® View)

• Registration Number: NCT03807271
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-12
• Study Start: 2019-01-14
• Study First Posted: 2019-01-16
• Primary Completion: 2019-11-13
• Study Completion: 2019-11-13
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean Arterial Pressure (MAP)	Maximum 5 hours

Secondary Outcome Measures

Name	Time	Method
Total dosis of Ephedrine in milligrams	Maximum 5 hours
Duration of surgery in minutes	Maximum 5 hours
Total dosis of Norepinephrine in micrograms	Maximum 5 hours
Bispectral Index (BIS)	Maximum 5 hours
Total dosis of Propofol in milligrams	Maximum 5 hours
Heart Rate (HR)	Maximum 5 hours
Total dosis of Phenylephrine in micrograms	Maximum 5 hours
Total dosis of Remifentanil in micrograms	Maximum 5 hours
Total dosis of Atropine in micrograms	Maximum 5 hours
Time until extubation in minutes	Maximum 5 hours
Duration of anesthesia in minutes	Maximum 5 hours
Duration of stay in postoperative ward in minutes	Maximum 2 days

Trial Locations

Locations (1)

Anestesiavdeling Lillehammer Sykehus; 🇳🇴 Lillehammer, Oppland, Norway