Comparison · NCT02004613-sae
Dexmedetomidine vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Dexmedetomidine vs Placebo: serious adverse events. Trial comparisons, record NCT02004613-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02004613-sae
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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 | 0.0533 | 0.0351 | 0.0801 | wilson | |
| Risk in group 2 | 0.0205 | 0.0104 | 0.0399 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0328 | 0.00617 | 0.0614 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.6 | 1.16 | 5.8 | log | |
| Odds ratio, group 1 over group 2 | 2.69 | 1.18 | 6.15 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Dexmedetomidine than on Placebo | 30.5 | 16.3 | 162 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Dexmedetomidine | Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.~Dexmedetomidine: Dexmedetomidine | 21 | 394 | EG000 |
| Group 2 | Placebo | normal saline administration matching dexmedetomidine rate of infusion.~Placebo: Normal saline administration matching dexmedetomidine rate of infusion | 8 | 390 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 5 days
Source ClinicalTrials.gov
Trial
- Title
- Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
- NCT number
- NCT02004613
- Phases
- PHASE4
- Conditions
- Heart Disease
- Interventions
- Dexmedetomidine, Placebo
- Lead sponsor
- The Cleveland Clinic
- Results first posted
- 2021-04-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02004613?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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