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. 2015 Jul 29;2015(7):CD007399. doi: 10.1002/14651858.CD007399.pub2

Miner 2007.

Methods Randomized, non‐blinded prospective trial
Participants Adults > 18 years old requiring procedural sedation
Interventions Propofol 1 mg/kg bolus, followed by 0.5 mg/kg every 3 minutes as needed
Etomidate 0.1 mg/kg, followed by 0.05 mg/kg every 3‐5 minutes as needed
Outcomes
  • Depth of sedation (measured via bispectral index monitor and a subjective scale ‐ OAAS). Rate of subclinical respiratory depression (measured by rise in EtCO2, falling SpO2)

  • Rate of clinical signs of respiratory depression (need for increased supplemental O2, use of bag‐valve mask to deliver O2, need for re‐positioning or stimulation)

  • Time to return to baseline mental status myoclonus, success of procedure

  • Participant outcome factors of perceived pain, recall and satisfaction with care received (measure using VAS)

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "using computer generated random numbers by the investigators"
Allocation concealment (selection bias) Low risk Quote: "selecting a sequentially numbered sealed envelope containing the group assignment"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: all participants who received study drugs were analysed. 109/110 allocated to propofol received the drug. 105/110 allocated to etomidate received the drug
Other bias Low risk Comment: no obvious "other bias" identified
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "we were unable to blind patients, physicians, or data collectors to the agent used in each procedural sedation"
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: it is unclear whether assessors were blinded to outcome measurements. Some measurements were recorded by research assistants who may not have been aware of outcome measures but some were documented by the physicians who ‐ quote: "were likely to have preconceived notions about the 2 agents". Some outcome measures came from the participants themselves, who may have been unaware of the outcomes