Shin 2012.
| Methods | Study design: randomized parallel groups Study dates: not stated |
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| Participants | Country: Korea Sex: female and male Age: 37‐38 ASA: I Procedure: elective orthopaedic or extremity surgeries Study size: 90 |
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| Interventions |
Randomized portion of anaesthetic: parts of volatile agent 3 doses ±infusion of narcotics (TCI) Intervention 1: maintenance: 4% to 6% inspired desflurane + target‐controlled concentration (TCI) 1 ng/mL, N = 30 Intervention 2: maintenance: 4% to 6% inspired desflurane + (TCI) 2 ng/mL remifentanil, N = 30 ‐ 2 = 28 Intervention 3: 7% to 9% inspired desflurane only without remifentanil infusion BIS both groups, N = 30 |
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| Outcomes | Primary outcomes: Quote: "optimal target‐controlled concentration of remifentanil combined with desflurane, by using a more widely and decreasing end‐tidal concentration of desflurane" Secondary outcome: awareness/wakefulness as defined using an awareness classification system (see Table 1): class 1 Comment: awareness events: none |
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| Notes |
Non‐randomized portion of anaesthetic: parts of volatile agent/N2O no + muscle relaxants yes for both induction/maintenance/ADM BIS recorded Induction propofol 2 mg/kg and lidocaine 0.5 mg/kg, vecuronium 0.15 mg/kg IV intubation vecuronium 0.02 mg/per stimulator algorithm Comment: inhalation vs inhalation (balanced anaesthesia): desflurane vary ET with varied infusion rate remifentanil: BIS both groups Comment: infusion remifentanil allows a wider range of volatile gent: see Dryad topic Emailed Dr Shin, smkeun311@yahoo.co.kr, the ROB survey 3 January 2014 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomization into one of the three groups was based on an Excel random‐number generation" |
| Allocation concealment (selection bias) | Unclear risk | Comment: inadequate information provided Quote: "...were registered and randomly allocated to receive either a target‐controlled concentration" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: no evidence of blinding. TIVA vs volatile agent. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: inadequate information provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 2 patients excluded: systolic blood pressure was below 90 mmHg (1 in group R2) and BIS > 60 >= 2 min (1 in group R2) treated immediately. Postoperative interview: no awareness report; following up with the awareness interview in these 2 excluded patients allowed us to grade the missing data as low risk. There was no significant difference between groups due to exclusions (2/60 vs 0/30), Peto OR 4.56 (0.24 to 87.68) (P = 0.31) |
| Selective reporting (reporting bias) | Low risk | Comment: awareness outcome part of inclusion criteria |
| Other bias | Unclear risk | Comment: inadequate information provided |