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. 2016 Oct 18;2016(10):CD007272. doi: 10.1002/14651858.CD007272.pub2

Lehmann 2007.

Methods Study design: randomized parallel groups
 Study dates: "2004" (email bias survey, see notes)
Participants Country: Germany
Sex: both
Age: 65
Procedure: coronary artery bypass grafting
Study size: 66
Interventions Randomized portion of anaesthetic: ADM vs SCP
Intervention 1: BIS 50 (45 to 55) N = 33
Intervention 2: BIS 40 (35 to 45) N = 33
Simultaneously, state entropy and response entropy were recorded
Outcomes Primary outcomes: Quote: "designed and powered to compare differences in the values of BIS and spectral entropy"
Secondary outcome: awareness/wakefulness as defined using an awareness classification system (see Table 1): class 1
Comment: no recall
Notes Non‐randomized portion of anaesthetic: parts of IV N2O no/narcotics/hypnotics bolus MCI/muscle relaxant induction yes/maintenance yes ADM entropy measured
BIS 50 group induction: midazolam (0.07 mg/kg) + sufentanil (1 µg/kg) + pancuronium (0.1 mg/kg); maintenance: sufentanil 1.5 µg to 2 µg/kg/h + midazolam 0.03 mg to 0.07 mg/kg and sufentanil 0.5 µg to 1 µg/kg as needed
BIS 40 group induction: midazolam (0.1 mg/kg) + sufentanil (1.5 µg/kg) + pancuronium (0.1 mg/kg): maintenance: sufentanil 0.5 µg to 1.5 µg/kg/h + midazolam 0.05 µg to 0.1 µg/kg and sufentanil 1 µg to 2 µg/kg as needed
Anaesthesia maintenance: O2 in air 50% + pancuronium 0.03 mc/kg as needed
The spectral entropy parameters RE and SE were measured
Comment: see Dryad topic reduction in inotropic support
Time of outcome determination: third day after surgery
Method of outcome determination: interview
Survey response: 18 January 2011, andreasa@klilu.de
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "flipping coin" (email bias survey, see notes)
Allocation concealment (selection bias) High risk Quote: "No concealment" (email bias survey, see notes)
Comment: the randomization is to an open BIS endpoint of 40 and 50 and anaesthesia is targeted to a specific BIS endpoint value of 40 or 50. As in other RCTs merged into a meta‐analysis in this review, there would be no downgrade for this method of allocation in determining the quality of evidence.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "Patient" (email bias survey, see notes)
Comment: impact on quality of evidence the same as above
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "Patient" (email bias survey, see notes)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "Data were complete in all patients." (email bias survey, see notes)
Selective reporting (reporting bias) Low risk Quote: "Study protocol is available; primary and secondary outcomes have been reported. Study was not designed to detect awareness" (email bias survey, see notes)
Quote: "Hemodynamics, mixed venous oxygen saturation were recorded but not reported" (email bias survey, see notes)
Other bias Low risk Quote: "BIS and entropy values were manually recorded" (email bias survey, see notes)