Whitwam 1983.
Methods | Single‐centre parallel‐group randomized controlled trial conducted in the United Kingdom | |
Participants | 100 adult ASA I ‐ II participants undergoing upper GI endoscopy (29 men (58%) in midazolam group and 30 men (60%) in diazepam group; mean age 42 ± 19.9 in midazolam group and 44 ± 18.5 in diazepam group) | |
Interventions | Intravenous administration of: 1) midazolam 0.07 mg/kg 2) diazepam 0.15 mg/kg |
|
Outcomes |
Measured during the procedure: Number of participants rated as 'anxious' Difficulty performing procedure Participant co‐operation Onset of sedation Offset of sedation Oversedation Measured on discharge from recovery area: Anterograde amnesia (recalled procedures) Measured after the procedure (questionnaire sent to participants ‐ no timeframe reported) Quality of recovery |
|
Notes | Reported that 2 of the authors were supported by Roche Inc. | |
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 | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blind to investigators assessing participants |
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 |