Bhalla 2006.
Methods | Parallel‐group single‐centre randomized controlled trial conducted in India in 2000 | |
Participants | 252 adults undergoing diagnostic or therapeutic upper gastrointestinal endoscopy. Authors stated that there were no difference in baseline characteristics of the 3 groups | |
Interventions | 1) Intravenous midazolam 5 mg (3 mg if older than 65) 2) Intravenous diazepam 5 mg (3 mg if older than 65) 3) Intravenous saline (placebo) |
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Outcomes |
Measured during the procedure: Vital signs (minimum oxygen saturation) Vital signs (oxygen desaturation < 90%) Vital signs (tachycardia defined as heart rate > 140 bpm) Vital signs (bradycardia) Vital signs (hypertension defined as systolic blood pressure > 200 mmHg) Incomplete procedures Difficulty performing procedure Discomfort/pain |
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Notes | Conflicts of interest or funding sources were not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Block randomisation" |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Endoscopist and investigator recording haemodynamic data were not aware of the nature of the medications |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Endoscopist and investigator recording haemodynamic data were not aware of the nature of the medications |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up 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 | None expected |