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. 2015 Mar 24;2015(3):CD010824. doi: 10.1002/14651858.CD010824.pub2

Parlak 2006.

Methods RCT, parallel design
Participants
  • 74 adult participants

  • Elective and emergency procedures for participants with atrial fibrillation

  • ASA status not given

  • Emergency department and coronary care unit, Turkey

Interventions
  • < 65 years. Fentanyl (1 µ/kg iv). 3 minutes later 2 mg midazolam (1 mL = 1 mg) over 20‐30 seconds until reached RSS‐5. Then 1 mg of midazolam every 2 minutes

  • < 65 years. Fentanyl (1 µ/kg iv). 3 minutes later 20 mg propofol (1 mL = 10 mg) over 20‐30 seconds until reached RSS‐5. Then 20 mg propofol every 2 minutes

  • ≥ 65 years. Fentanyl (0.5 µ/kg iv). 3 minutes later 2 mg midazolam (1 mL = 1 mg) over 20‐30 seconds until reached RSS‐5. Then 1 mg midazolam every 2 minutes

  • ≥ 65 years. Fentanyl (0.5 µ/kg iv). 3 minutes later 20 mg propofol (1 mL = 10 mg) over 20‐30 seconds until reached RSS‐5. Then 20 mg propofol every 2 minutes


All groups given fentanyl citrate for preprocedural analgesia
Aim: participant sedated to Ramsey Sedation Scale level 5
Outcomes
  • Unintended apneic episodes

  • Patient awareness or recall

  • Time to loss of consciousness

  • Time to awakening

  • Patient satisfaction

Results < 65 years Midazolam vs < 65 years Propofol vs65 years Midazolam vs65 years Propofol
  • Apnoea: 1/12 vs 1/11 vs 6/25 vs 2/22

  • Recall: 0/12 vs 1/11 vs 4/25 vs 1/22

  • Patient satisfaction: satisfied 12/12 vs 11/11 vs 23/25 vs 20/22


Unsure if satisfied: 0/12 vs 0/11 vs 2/25 vs 2/22
Notes Four groups for 2 drug comparisons divided by age group (< 65 years, ≥ 65 years)
Anaesthetic administered by 2 final year medical residents from Emergency department and Anesthetic department
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Stratification by age and then computer software to generate random numbers
Allocation concealment (selection bias) Unclear risk No details of how allocation was concealed
Blinding of participants and personnel (performance bias) Major adverse events High risk Medical resident who administered anaesthetic aware of group allocation
Blinding of participants and personnel (performance bias) Patient reported outcomes (recall/satisfaction) High risk Medical resident who administered anaesthetic aware of group allocation
Blinding of participants and personnel (performance bias) Success of cardioversion High risk Medical resident who administered anaesthetic aware of group allocation
Blinding of participants and personnel (performance bias) Minor adverse events High risk Medical resident who administered anaesthetic aware of group allocation
Blinding of participants and personnel (performance bias) Time to induction etc/need for resedation. High risk Medical resident who administered anaesthetic aware of group allocation
Blinding of outcome assessment (detection bias) Major adverse event Low risk Researcher who collected data was blinded to participant treatment allocation. Blinding achieved by obscuring participant's arm
Blinding of outcome assessment (detection bias) Patient reported outcomes (recall/satisfaction) Low risk Researcher who collected data was blinded to participant treatment allocation. Blinding achieved by obscuring participant's arm
Blinding of outcome assessment (detection bias) Success of cardioversion Low risk Researcher who collected data was blinded to participant treatment allocation. Blinding achieved by obscuring participant's arm
Blinding of outcome assessment (detection bias) Minor adverse events Low risk Researcher who collected data was blinded to participant treatment allocation. Blinding achieved by obscuring participant's arm
Blinding of outcome assessment (detection bias) Time to induction etc./need for resedation Low risk Researcher who collected data was blinded to participant treatment allocation. Blinding achieved by obscuring participant's arm
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Four participants excluded “because of difficulties in data collection”. Only 5%
Selective reporting (reporting bias) Unclear risk All outcomes from methods section reported
Prepublished protocol not sought
Other bias Low risk Baseline characteristics largely comparable – given stratification by age