Bonato 2001.
| Methods | Study design: randomized parallel groups Study dates: not stated |
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| Participants | Country: Italy Sex: female and male Age: mean age 64 and 63 years (range 28 to 75) ASA: cardiac surgery: II‐IV Procedure: cardiac surgery Study size: 93 |
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| Interventions |
Randomized portion of anaesthetic: ADM BIS 60 vs 40: implicit memory test Control group: N = 20 73 subjects (experimental group) Group A: N = 35 Group B: N = 38 Intervention 1: BIS 60 (word list played) Intervention 2: BIS 40 |
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| Outcomes | Primary/secondary outcomes: awareness/wakefulness as defined using an awareness classification system (see Table 1): class 2 Quote: "significant intraoperative implicit memory was found (P < 0.005), but no patient had spontaneous or directed recall of intraoperative events" |
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| Notes |
Non‐randomized portion of anaesthetic: parts of TIVA: N2O no/narcotics/hypnotics bolus MCI/muscle relaxants induction yes/maintenance yes Remifentanil‐propofol‐vecuronium‐vecuronium, CPB The mean dose of propofol group A was 1.9 mg/kg/h, group B 2.3 mg/kg/h; remifentanil mean dose required in the 2 groups is the same: 0.45 mg/kg/min Translated by AM No email address available for ROB survey |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "...prospective, randomised study" |
| Allocation concealment (selection bias) | Unclear risk | Comment: inadequate information |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: anaesthesiologists targeted anaesthesia to 2 different endpoints, BIS 60 and 40 |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "a standardised interview was conducted to determine the extent of intraoperative explicit memory and a Word Stem" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no missing data |
| Selective reporting (reporting bias) | Low risk | Comment: primary outcome: implicit memory; secondary outcome: awareness Comment: awareness outcome part of inclusion criteria |
| Other bias | Unclear risk | Comment: inadequate information |