Bianchi Porro 1988.
Methods | Single‐centre cross‐over randomized controlled trial conducted in Italy | |
Participants | 23 adults undergoing upper gastrointestinal endoscopy (14 men and 9 women; mean weight 60.7 kilograms; age range 20 to 48 years; mean age 32.5) | |
Interventions | 1) Intravenous midazolam 0.07 mg/kg 2) Intravenous Diazepam 0.15 mg/kg |
|
Outcomes |
Measured during the procedure: Vital signs (blood pressure 5 minutes after sedation) Vital signs (heart rate 5 minutes after sedation Level of sedation using a sedation assessment scale 4 Participant co‐operation Measured 2 hours after the procedure: Quality of recovery Measured 24 hours after the procedure: Anterograde amnesia (defined by number of participants who recalled the procedure) |
|
Notes | At least 30 days between procedures We were unable to locate contact details of the authors to access pre‐cross‐over data 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 | Low risk | Drugs prepared and administered by physician not performing endoscopy or assessments |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Drugs prepared and administered by physician not performing endoscopy or assessments |
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 |