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Comparison · NCT03330236-cae20d59

EEG Guided vs Usual Care: Number of Participants With Postoperative Delirium

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. EEG Guided vs Usual Care: Number of Participants With Postoperative Delirium. Trial comparisons, record NCT03330236-cae20d59. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03330236-cae20d59

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.01030.005250.0203wilson
Risk in group 20.01160.006130.022wilson
Risk difference, group 1 minus group 2-0.00128-0.01280.0101newcombe hybrid score
Risk ratio, group 1 over group 20.890.3452.29log
Odds ratio, group 1 over group 20.8890.3412.32log
Number needed to treat, for one fewer participant with the outcome on EEG Guided than on Usual Care782from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: usual care.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1EEG Guided
All patients in the EEG Guided study arm will receive the anesthetic care guided by the SedLine EEG Brain Function Monitor in addition to the conventional monitors. In addition to the conventional/standard interventions of anesthetic care, an additional intervention related to this trial is the anesthetic depth management via the titration of the propofol and remifentanil infusion rates to maintain SEF and PSI in the targeted ranges based on the SedLine EEG monitoring.~Anesthetic depth management: The propofol and remifentanil infusion rates will be adjusted to maintain the spectral edge frequency (SEF) value at 10-15 and the patient state index (PSI) value at 25-50 based on the SedLine EEG Brain Function Monitoring.
8773OG000
Group 2Usual Care
All patients in the usual care arm (control) will receive the anesthetic care guided by the conventional monitors only. Patients in the control arm will be monitored using the SedLine EEG Brain Function Monitor; however, the screen of this monitor will be covered by an opaque cloth and blinded to the anesthesia team.
9774OG001

Outcome

Type
PRIMARY
Title
Number of Participants With Postoperative Delirium
Description
The Number of Participants with Postoperative Delirium is operationally defined as the count of patients with postoperative delirium. Postoperative delirium is an acute brain dysfunction characterized by inattention, disorganized thinking, and a fluctuating course.
Time frame
up to five (5) days after surgery
Population
Modified ITT population

Source ClinicalTrials.gov

Trial

Title
EEG - Guided Anesthetic Care and Postoperative Delirium
NCT number
NCT03330236
Phases
NA
Conditions
Delirium, Emergence Delirium, Anesthesia, General, Electroencephalography, Laparoscopy, Surgical Procedures, Operative
Interventions
Anesthetic "depth" management
Lead sponsor
Yale University
Results first posted
2020-11-09

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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