Effectiveness of the advisory display SmartPilot® view in the assessment of anesthetic depth in low risk gynecological surgery patients: a randomized controlled trial

Abstract

Background: Assessment of appropriate anesthetic depth is crucial to prevent harm to patients. Unnecessary deep anesthesia can be harmful, potentially causing acute renal failure, myocardial injury, delirium, and an increased mortality rate. Conversely, too light anesthesia combined with muscle relaxants can result in intraoperative patient awareness and lead to serious psychological trauma. This trial aimed to ascertain the effectiveness of the advisory display SmartPilot® View (SPV), as a supplemental measure in the assessment of anesthetic depth in low risk gynecological surgery patients. The hypothesis was that the use of the SPV would increase the precision of assessment, and result in a higher mean arterial pressure.

Methods: This trial used a randomized, controlled, single-blind design with a homogeneous sample. Patients undergoing minor, low risk gynecological surgery were randomly assigned to two groups: a test group wherein current standards were supplemented with the advisory display SPV and a control group assessed using only the current standards. Female patients aged between 18 and 75 years with American Society of Anesthesiologists Physical Status Classification System scores of 1-3 undergoing planned general anesthesia using the total intravenous anesthetic method, combining propofol and remifentanil, were included. The exclusion criteria included a body mass index ≥ 35 kg/m2, a history of alcoholism, drug intake affecting propofol and remifentanil dynamics, and inability to consent. The independent sample t-test and chi-square test or Fisher's exact test were used to assess the statistical significance of differences between the two groups.

Results: A total of 114 patients were included in the analysis (test group n = 58, control group n = 56). No significant differences in the mean arterial pressure, heart rate, bispectral index, extubation delay, or post-anesthesia care unit stay were found between groups.

Conclusions: The addition of the advisory display SmartPilot® View to current standards in the evaluation of anesthetic depth had no significant effect on the outcome.

Trial registration: The trial was registered on January 16th 2019 with ClinicalTrials.gov (ref: NCT03807271 ).

Keywords: Advisory display; Anesthetic depth; SmartPilot® View.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1

Flow diagram. Flow diagram of the enrollment process: 132 patients were assessed for eligibility, of whom four declined the invitation to participate; 128 patients were randomly assigned to the test or control groups, with 64 participants in each group. Six participants were excluded from the test group, due to technical issues, intake of potentiating drugs, pacemaker, and fever. Eight participants were excluded from the control group due to technical issues, intake of potentiating drugs, body mass index ≥35 kg/m2, and change in the anesthetic method. Data from 58 participants in the test group and 56 participants in the control group were included in the analysis.