Stoppe 2013.
Methods | Design: Randomised controlled trial Date of study: Study dates not reported Power calculation: Yes Frequency of outcomes assessment: daily postoperatively Inclusion criteria: undergoing elective isolated coronary artery bypass grafting (CABG) with the use of cardiopulmonary by‐pass (CPB); age > 50 years; ASA physical status II‐IV; preserved cardiac function (left ventricular ejection fraction > 50%) and EuroSCORE < or equal to 8 Exclusion criteria: cardiac, respiratory, liver or renal failure; acute coronary syndrome within 24 hours before surgery; haemodynamic instability; emergency operations; lack of informed consent; severe neurological dysfunction; depression; a geriatric depression score (GDS) > 5; MMSE <24; patients with a predisposition to malignant hyperthermia and/or hypersensitivity to the study drugs; women with childbearing potential or pregnancy. |
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Participants | Number in study: 30 Country: Germany Setting: Cardiac surgery inpatients Age: Mean age 66 (48‐81) in xenon group; 68 (51‐79) in sevoflurane group Sex: 80% of both groups were male Co‐morbidity: not reported at baseline Dementia: MMSE< 24 were excluded |
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Interventions | Both groups received induction of anaesthesia with propofol and sufentanil. Muscle relaxation was obtained with rocuronium. Anaesthetic depth was adjusted by titration of end‐expiratory xenon or sevoflurane concentrations according to changes in physiological parameters and BIS values. During CPB, patients received a propofol infusion instead of xenon or sevoflurane. Xenon: Maintenance of anaesthesia was achieved by continuous infusion of sufentanil and xenon (end‐expiratory concentrations of 45‐50 vol%) Sevoflurane: Maintenance of anaesthesia was achieved by continuous infusion of sufentanil and sevoflurane (end‐expiratory concentrations of 1‐1.4 vol%) |
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Outcomes | 1. Incidence of delirium, using CAM‐ICU 2. Mortality 3. Length of stay 4. Adverse events |
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Notes | Funding source: Deutsche Forschungsgemeinschaft (DFG) grants Declarations of interest: "MC and RR received lecture and consultant fees from Air Liquide Sante International, a company interested in developing clinical applications for medical gases, including xenon" Delirium not clearly excluded at enrolment |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Random sequence generation (selection bias) | Unclear risk | Method not described, states patients "randomly assigned to receive...." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and staff not clearly blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessments conducted by trained study scientists blinded to allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised patients were included in the analysis |
Selective reporting (reporting bias) | Low risk | Protocol registered on ClinicalTrials.gov and trial reported in accordance with published protocol |
Other bias | Low risk | No evidence of other bias |