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) |