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

Kerssens 2009.

Methods Study design: randomized parallel groups
Study dates: Quote: "January 2004 to February 2007" (email bias survey, see notes)
Participants Country: USA
Sex: both
Age: 61.2, 63.9
Procedure: joint replacement surgery
Study size: 167 enrolled, 128 completed study
Interventions Randomized portion of anaesthetic: volatile agent types: ADM: BIS 50 to 60 vs SCPs
Intervention 1: BIS monitor used to guide anaesthetic, maintained between 50 to 60, N = 67
Intervention 2: BIS not seen, standard clinical signs to guide anaesthetic, N = 61
Outcomes Primary outcomes: effect of BIS‐guided anaesthesia vs SCP on memory recognition function
Secondary outcome: awareness/wakefulness as defined using an awareness classification system (see Table 1): class 1
Quote: "When interviewed postoperatively, three patients (2.3%) reported recall of the time period between falling asleep and waking up from anaesthesia"
Comment: 2 patients were in BIS group and 1 in SCP group. There was evidence of implicit memory in the BIS guided group compared to the SCP group.
Notes Non‐randomized portion of anaesthetic: parts of volatile agent: N2O no/narcotics/hypnotics bolus MCI/muscle relaxants induction yes/maintenance PRN
Anaesthesia induction: propofol 2 mg/kg + fentanyl 3 µg/kg + vecuronium bromide (0.1 mg/kg) tracheal intubation, additional doses as necessary; maintenance: sevoflurane in oxygen using standard ventilation parameters + fentanyl 50 µg to 100 µg + esmolol 0.5 mg/kg + phenylephrine 100 µg + fentanyl 50 µg to 100 µg/kg as needed. Physiologic parameters recorded: BIS, end‐tidal gas concentrations (but actual ET data reported) (every 5 s) and vital signs (every 3 min)
Time of outcome determination: 6 h postoperative
Method of outcome determination: interview questions
Comment: see Dryad topics BIS and implicit memory vs SCPs and dreams
Survey response: 10 March 2011, Chantal Kerssens ckerssens@simpleC.com
Author sent characteristics and ROB tables for comment 7 December 2013: ckerssens@simpleC.com
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were randomly assigned to one of two anaesthetic management groups using a computer‐generated list linking subject study numbers to group assignment"
Allocation concealment (selection bias) Unclear risk Comment: no information provided
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: no information provided
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: assessor: "Outcome assessors were blinded to study group allocation and tested patients postoperatively for recall and recognition memory. Recall was assessed approximately 6 h after surgery with five questions"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "Numbers are reported in the paper. The ratios and reasons for exclusion/attrition were comparable between groups." (email bias survey, see notes)
Author sent characteristics and ROB tables for comment 7 December 2013: ckerssens@simpleC.com
Selective reporting (reporting bias) Low risk Quote: "True" (email bias survey, see notes)
Comment: awareness outcome part of inclusion criteria
Other bias Low risk Quote: "Yes. We stopped enrolment/testing when the main study ‐unrelated to memory function ‐ reached it's target enrolment number." (email bias survey, see notes)