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Clinical Trials/NCT03807271
NCT03807271
Completed
Not Applicable

Computer-assisted Anaesthesia Using Pharmacokinetic/Pharmacodynamic Model

Norwegian University of Science and Technology1 site in 1 country114 target enrollmentJanuary 14, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, General
Sponsor
Norwegian University of Science and Technology
Enrollment
114
Locations
1
Primary Endpoint
Mean Arterial Pressure (MAP)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 14, 2019
End Date
November 13, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Standard premedication
  • General anesthesia, total intravenous anesthesia

Exclusion Criteria

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

Outcomes

Primary Outcomes

Mean Arterial Pressure (MAP)

Time Frame: Maximum 5 hours

Secondary Outcomes

  • 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)

Study Sites (1)

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