Comparison · NCT02820051-sae
Midazolam vs Propofol: serious adverse events
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. Midazolam vs Propofol: serious adverse events. Trial comparisons, record NCT02820051-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02820051-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 | 0.00000000000000000694 | 0.0727 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0676 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0676 | 0.0727 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | In the group of midazolam, the initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg.~Intervention: Transcutaneous CO2 monitor~Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group.~Midazolam: The initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale.~Nalbuphine: The starting dose was 2 mg | 0 | 49 | EG000 |
| Group 2 | Propofol | In the group of propofol, the starting dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg.~Intervention: Transcutaneous CO2 monitor~Transcutaneous CO2 monitor: Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group.~Propofol: The initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale.~Nalbuphine: The starting dose was 2 mg | 0 | 53 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- During bronchoscopy study and at sedation recovery period (on average 60 minutes from the beginning of the procedure)
Source ClinicalTrials.gov
Trial
- Title
- Non-anesthesiologist-administered Propofol During the Flexible Bronchoscopy
- NCT number
- NCT02820051
- Phases
- NA
- Conditions
- Conscious Sedation Failure During Procedure
- Interventions
- Transcutaneous CO2 monitor, Midazolam, Propofol, Nalbuphine, Lidocaine
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Results first posted
- 2024-12-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02820051?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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GET https://conductscience.org/api/comparisons/v1/NCT02820051-sae