N/A
Completed N=40
The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children
Emergence Agitation
Source: ClinicalTrials.gov NCT00990769 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit) — 8.6; 6.7 units on a scale — p=>0.05
Summary
The purpose of this study is to determine whether depth of anesthesia has an effect on emergence agitation (EA) in children age 2 - 8 years old. EA is a common problem in pediatric patients who receive general anesthesia with inhaled anesthetics, and the effect of depth of anesthesia on EA has not been studied. The study will randomize 40 children undergoing ophthalmologic surgery under general anesthesia to either light anesthesia (BIS 55-60) or deep anesthesia (BIS 40-45). EA will be measured by the peak Pediatric Assessment of Emergence Delirium (PAED) score in the recovery room, which rates agitation behaviors on a scale of 0 - 20. The hypothesis is that light anesthesia is associated with more EA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit) |
8.6; 6.7 | >0.05 |
| SECONDARY Time to Emergence From Anesthesia |
14; 12 | — |
| SECONDARY Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC) |
5.3; 3.5 | — |
Eligibility Criteria
Inclusion Criteria
- Children age 2 - 8 (inclusive) undergoing ophthalmologic surgery
- American Society of Anesthesiology (ASA) physical status 1 or 2
Exclusion Criteria
- Surgery precluding placement of BIS monitor
- Non-English speaking, until additional language consent forms are approved
- Previous history of severe emergence agitation
Data sourced from ClinicalTrials.gov (NCT00990769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.