Skip to main content
. 2015 Mar 24;2015(3):CD010824. doi: 10.1002/14651858.CD010824.pub2

Orko 1976a.

Methods RCT, parallel design
Participants
  • 150 adult participants

  • Elective procedure. No details of participants' diagnoses

  • ASA status not given

  • Hospital, Finland

Interventions
  • Diazepam given over period of 1 minute until speech sluggish and ptosis obvious (dose not given)

  • Thiopentone in 2.5% solution injected over 1 minute (dose not given)

  • Propanidid


All groups given atropine (0.01 mg/kg given iv 2 minutes) before anaesthesia
Aim: "when patient did not respond to questions, the level of anaesthesia was considered adequate"
Outcomes
  • Unintended apneic episodes

  • Other arrhythmia

  • Patient awareness/recall

  • Success of cardioversion

  • PONV

  • Myoclonus

  • Number of shocks

Results Diazepam vs Thiopentone
  • Apnoea: 2/50 vs 25/50 (P value < 0.001)

  • Recall: 15/41 vs 1/40 (P value < 0.001)

  • PONV: 0/50 vs 0/50

  • Myoclonus (defined as excitatory side effects, such as muscular tension or involuntary movements): 0/50 vs 4/50

  • Successful cardioversion: 42/50 vs 36/50

  • Mean number of shocks: 1.9 vs 2.1

Notes No effect estimates provided with data
Propanidid is no longer in use; therefore data were not taken from this group
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as randomized but no details given
Allocation concealment (selection bias) Unclear risk No details
Blinding of participants and personnel (performance bias) Major adverse events High risk Assume anaesthetist was aware of group allocation
Blinding of participants and personnel (performance bias) Patient reported outcomes (recall/satisfaction) High risk No details of blinding given. Assume anaesthetist was not blinded
Blinding of participants and personnel (performance bias) Success of cardioversion High risk No details of blinding given. Old study and assume cardiologist/surgeon was not blinded
Blinding of participants and personnel (performance bias) Minor adverse events High risk No details of blinding given. Assume anaesthetist was not blinded
Blinding of participants and personnel (performance bias) Time to induction etc/need for resedation. High risk No details of blinding given. Assume anaesthetist was not blinded
Blinding of outcome assessment (detection bias) Major adverse event Unclear risk No details given as to who recorded outcome data, although arrhythmias were analysed by someone unaware of group allocation
Blinding of outcome assessment (detection bias) Patient reported outcomes (recall/satisfaction) Unclear risk No details of whether participant was blinded
Blinding of outcome assessment (detection bias) Success of cardioversion Unclear risk No details given as to who recorded outcome data, although arrhythmias were analysed by someone unaware of group allocation
Blinding of outcome assessment (detection bias) Minor adverse events Unclear risk No details given as to who recorded outcome data, although arrhythmias were analysed by someone unaware of group allocation
Blinding of outcome assessment (detection bias) Time to induction etc./need for resedation Unclear risk No details given as to who recorded outcome data, although arrhythmias were analysed by someone unaware of group allocation
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No losses reported
Selective reporting (reporting bias) Unclear risk All outcomes appear to be reported from methods section
Prepublished protocol not sought
Other bias Low risk Baseline characteristics comparable