Comparison · NCT03330236-3585de8c
EEG Guided vs Usual Care: Non-delirium Complications
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: Non-delirium Complications. Trial comparisons, record NCT03330236-3585de8c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03330236-3585de8c
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.228 | 0.2 | 0.259 | wilson | |
| Risk in group 2 | 0.25 | 0.22 | 0.281 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0218 | -0.0643 | 0.0208 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.913 | 0.763 | 1.09 | log | |
| Odds ratio, group 1 over group 2 | 0.887 | 0.702 | 1.12 | log | |
| Number needed to treat, for one fewer participant with the outcome on EEG Guided than on Usual Care | 45.8 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | EEG 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. | 175 | 768 | OG000 |
| Group 2 | Usual 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. | 193 | 773 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Non-delirium Complications
- Description
Complications after surgery such as acute kidney injury, cardiac events, cerebrovascular events, renal injury, GI complications, infections (etc) were assessed using the Clavien-Dindo classification. Reported are the count of those with a composite complication Clavien-Dindo Grade ≥II.~The classifications are as follows:~Grade I = Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.~Grade II = Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusionsand total parenteral nutritionare also included.~Grade III = Requiring surgical, endoscopic or radiological intervention; IIIa = Intervention not under general anesthesia; IIIb = Intervention under general anesthesia.~Grade IV = Life-threatening complication (including CNS complications)\* requiring IC/ICU-management; IVa = single organ dysfunction (including dialysis); IVb
- Time frame
- within 30 days after surgery
- Population
- Modified ITT population/patients with valid data.
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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03330236?tab=results
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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