Rolo 2012.
Methods | Multicentre (2 sites) parallel‐group randomized controlled trial conducted in Portugal | |
Participants | 100 adults undergoing fibreoptic bronchoscopy (Mean age was 56 ± 14 years (range 18 ‐ 79 years); 66% were men | |
Interventions | 0.05 mg/kg intravenous midazolam Placebo |
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Outcomes |
Measured during the procedure: Level of sedation on a sedation assessment scale Vitals signs Disinhibition/excitation (measured in the trial as 'agitation') Sedation reversal Measured 1 hour after the procedure: Participant satisfaction (willingness to undergo another procedure with the same medication) |
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Notes | Conflicts of interest or funding sources were not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Did state it was double‐blind but no specific information provided about how this was achieved |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals |
Selective reporting (reporting bias) | Unclear risk | No clear evidence that measured outcomes were not reported (trial protocols were not sought for confirmation) |
Other bias | Low risk | None expected |