Fakheri 2010.
Methods | Single‐centre parallel‐group randomized controlled trial conducted in Iran in 2008 | |
Participants | 180 adults over 18 years of age without serious comorbidities undergoing upper gastrointestinal endoscopy (mean age: 46.9 ± 17.5 years in midazolam group and 47 ± 17.5 years in placebo group; 49% men in midazolam group and 43% men in placebo group) | |
Interventions | 1) Intravenous midazolam ‐ mean dose 3.2 (1.6) mg 2) Saline placebo |
|
Outcomes |
Measured during the procedure: Vital signs (oxygen desaturation) |
|
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 | High risk | Not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Excluded participants who required more than 10 mg midazolam for sedation |
Selective reporting (reporting bias) | Unclear risk | No clear evidence that measured outcomes were not reported (trial protocols were not sought for confirmation) |
Other bias | Unclear risk | None expected |