Comparison · NCT04807101-50b93fcd
Midazolam and Fentanyl vs Midazolam Alone: 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. Midazolam and Fentanyl vs Midazolam Alone: Adverse Events. Trial comparisons, record NCT04807101-50b93fcd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04807101-50b93fcd
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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 | 0.00658 | 0.00116 | 0.0363 | wilson | |
| Risk in group 2 | 0.0135 | 0.00371 | 0.0479 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00693 | -0.0418 | 0.0244 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.487 | 0.0446 | 5.31 | log | |
| Odds ratio, group 1 over group 2 | 0.483 | 0.0434 | 5.39 | log | |
| Number needed to treat, for one fewer participant with the outcome on Midazolam and Fentanyl than on Midazolam Alone | 144 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Midazolam and Fentanyl | Patients in this arm will receive standard conscious sedation with midazolam and fentanyl | 1 | 152 | OG000 |
| Group 2 | Midazolam Alone | Patients in this arm will receive conscious sedation with medazepam alone~midazolam alone: elimination of fentanyl from conscious sedation | 2 | 148 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Adverse Events
- Description
- Oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted
- Time frame
- 1 day
- Population
Source ClinicalTrials.gov
Trial
- Title
- Sedation Regimens in GI Endoscopy
- NCT number
- NCT04807101
- Phases
- EARLY_PHASE1
- Conditions
- Anesthesia, Endoscopy, Colonoscopy, Conscious Sedation
- Interventions
- midazolam alone
- Lead sponsor
- Greg S Cohen MD LLC
- Results first posted
- 2024-04-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04807101?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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