Ellis 1994.
Methods | Randomized controlled trial comparing clonidine versus placebo. | |
Participants | 61 people, with a diagnosis or risk factors of coronary artery disease, who were undergoing major non‐cardiac surgery (82% vascular) Age (yr): median (IQR): clonidine group: 69 (61‐74); placebo group: 68 (63‐75). Sex: 29 men, 32 women. Exclusion criteria: chronic methyldopa or clonidine therapy, serum creatinine > 30 mg/dL, planned carotid endarterectomy surgery, planned thoracic aortic aneurysm surgery, pulse < 50 bpm, or PR interval > 0.24 sec. |
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Interventions |
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Outcomes |
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Notes | Study was terminated early at 61 participants due to low incidence of ischaemia. It was originally designed to recruit 160 participants in 2 arms. Funding: Anesthesiology Young Investigator Award from the Foundation for Anesthesia Education and Research. Declaration of interest: not stated. Recruitment dates: November 1990 to May 1992. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Authors reported use of computer‐generated random numbers. |
Allocation concealment (selection bias) | Low risk | Sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Authors reported that all participants and clinicians were blinded to treatment assignment throughout study. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessment by an investigator not involved in care of participant, blinded to allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All data reported. |
Selective reporting (reporting bias) | Low risk | Outcomes reported were concordant with methods. |
Other bias | High risk | Study terminated early because of a lower than expected rate of myocardial ischaemia; unclear whether this unblinded interim analysis was prespecified. |