Abd El‐Hakeem 2003.
| Study characteristics | ||
| Methods | Single‐centre, prospective, randomised, double‐blind placebo‐controlled study Registration dates: not specified Number of study centres: 1 Location: Egypt |
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| Participants | Twenty people undergoing elective mitral valve replacement or AVR with CPB People with severely impaired LV function (EF < 50%), ischaemic heart disease, low cardiac output syndrome, uncontrolled rapid AF, or tight mitral stenosis and those with severe systemic noncardiac disease, infectious disease, or poorly controlled diabetes mellitus, as well as those receiving corticosteroids or other immunosuppressive treatment, were excluded from the study. |
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| Interventions | Intervention group: 100 mg dexamethasone before induction Control group: placebo control |
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| Outcomes | Perioperative TNF‐α, IL‐6, IL‐8, IL‐10, and postoperative cardiac index, PCWP and pulmonary function | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was done by using a sealed‐envelope method, by third party. |
| Allocation concealment (selection bias) | Low risk | Randomisation performed by an anaesthesiologist not involved in the participants' care |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Intervention given by third party prior to commencement of procedure, and placebo given to controls |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information was given on blinding specifically, but randomisation was performed by a third party, and we have judged the overall risk as low because intervention and control placebo were given preprocedurally and a separate team delivered care. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All expected outcomes reported for 20 participants as expected from methodology |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported in line with methodology, and outcomes that would be expected from this study design were reported. |
| Other bias | Low risk | None noted |