Is the Patient State Index Recorded with the Sedline Sedation Monitor Correlated with the Duration of Emergence After Pediatric Surgery: An Exploratory, Single-center, Blinded, Prospective Cohort Study

Abstract

Introduction Following surgery with general anesthesia, some children experience a prolonged emergence. We designed a prospective observational study in children undergoing general anesthesia who were monitored with the SedLine® Sedation Monitoring system (Masimo Corporation, Irvine, CA) to explore the hypothesis that the Patient State Index (PSI) obtained with this monitor could be inversely correlated with the duration of emergence after anesthesia.

Materials and methods Prospective, observational single center study in a tertiary academic center in the United States. Fifty-six children between the ages of 1 and 12 years scheduled to undergo non-emergent surgery with general inhalational anesthesia were enrolled. Demographic and intraoperative characteristics were recorded. All caregivers were blinded to the PSI. Correlations were derived between PSI, duration of emergence, post-anesthesia care unit length of stay (LOS), and hospital LOS. PSI was analyzed in categories of <25, 25-50, and >50 both as absolute time spent in each category, and as the fraction of time compared to the length of the anesthetic. The development of emergence delirium (ED) was recorded as a secondary outcome variable.

Results The correlation coefficients between the PSI categories and the outcomes were weak (<0.3). Only two of the correlation coefficients reached statistical significance at p=0.05: fraction and absolute time spent in PSI category > 50 and PACU length of stay, indicating that longer periods of PSI > 50 during the anesthetic were associated with longer PACU LOS. Three patients (5%) developed ED.

Conclusion PSI measured with the SedLine monitor was not significantly correlated with the duration of emergence. There was a weak positive correlation between intraoperative time spent with PSI readings >50 and PACU LOS. Our sample did not have a high-enough event rate of ED to make statistical inferences about a correlation between PSI, ED and duration of emergence.

Competing Interest Statement

An unrestricted educational grant was supplied by Masimo Corporation. They did not have any input or influence on the study design, data collection, or data reporting.

Funding Statement

An unrestricted educational grant was supplied by Masimo Corporation.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Institutional Review Board of Cooper University Healthcare gave ethical approval for this work.

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Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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Data Availability

All data produced in the present work are contained in the manuscript.

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