Yuno 1996.
Methods | Single‐centre parallel‐group randomized controlled trial conducted in Japan | |
Participants | 40 adults undergoing colonoscopy for polyp removal | |
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 Participant satisfaction (measured in the trial as participant‐assessed adequacy of sedation) Proceduralist satisfaction (measured in the trial as proceduralist‐assessed adequacy of sedation) Vital signs |
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Notes | Reported that a grant from the Osaka Association for Prevention of Adult Diseases funded the study. No conflicts of interest were reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Low risk | "Envelope method" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Noted it was double‐blind but no specific information provided |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Noted it was double‐blind but no specific information provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals reported |
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 | No withdrawals reported |
ASA: American Society of Anesthesiology BPM: beats per minute GI; gastrointestinal HR: heart rate MRI: magnetic resonance Imaging RCT: randomized controlled trial SBP: systolic blood pressure