Wu 2008.
Methods | RCT, parallel design, single centre, Chang Gung Memorial Hospital, Kaohsiung 833, Taiwan, ROC | |
Participants | Total participants = 68, data of 3 participants excluded because of missing data M/F: entropy: 28/6; standard practice: 25/6 Inclusion criteria: ASA physical status I or II participants of either gender, scheduled for total knee replacement, all participants received general anaesthesia without regional analgesia reinforcement Exclusion criteria: history of cerebrovascular disease, treatment with psychoactive medication, existing cardiac dysrhythmia, weight less than 70% or more than 130% of ideal body weight |
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Interventions | 1.Standard practice group: (n = 31) (sevoflurane titrated using routine clinical signs) 2. Entropy group: (n = 34) (sevoflurane titrated to keep SE, RE values between 35‐45) |
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Outcomes | 1.All participants were interviewed in the PACU in the 72 hour postoperative period about explicit recollection of the procedure they had undergone 2.The consumption of sevoflurane, the sole inhalational agent used, in the entropy‐assisted group and in the conventional group was also assessed |
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Notes | Authors contacted for information on duration of study and other queries, but no response from authors. This work was supported in part by the National Science Council (NMRPG 850311), the Statistical Analysis Laboratory, the Department of Medical Research of Kaohsiung Medical University Hospital and the University itself for its help | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Authors have stated patients were randomized, but method of randomization not described; authors contacted, no response |
Allocation concealment (selection bias) | Unclear risk | Not specified; authors contacted, no response.However, the review authors feel that this domain does not affect the outcomes of the review |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | 1. All participants had entropy sensors attached before operation and anaesthesia induction; therefore were blinded 2. Entropy values were used to titrate sevoflurane in entropy group and haemodynamic changes and clinical signs in the conventional group, but there is no mention if the personnel/anaesthetists were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned; authors contacted, no response |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No, data of 65 out of 68 participants analysed. Only 3 participants of control group excluded because of missing data |
Selective reporting (reporting bias) | Low risk | All outcomes mentioned in methodology have been reported |
Other bias | Low risk | Nothing suggestive |
ASA ‐ American Society of Anesthesiologists BIS: Bispectral Index CNS: central nervous system
CPB: cardiopulmonary bypass
EEG: electroencephalography F: female ICU: intensive care unit M: male PACU: postanaesthesia care unit RCT: randomized controlled trial RE: response entropy SE: state entropy