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. 2016 May 20;2016(5):CD009491. doi: 10.1002/14651858.CD009491.pub2

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
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)
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