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. 2018 Mar 6;2018(3):CD004126. doi: 10.1002/14651858.CD004126.pub3

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.
Interventions
  1. Clonidine transdermal patch 200 μg/day for 72 hr from night before surgery. In addition, clonidine 300 μg orally 60‐90 min before surgery.

  2. Placebo skin patches and tablets were administered in an identical protocol.

Outcomes
  1. All‐cause mortality (7 days).

  2. MI (persistent new Q‐wave on ECG, or CK‐MB > 40 IU) (7 days).

  3. Myocardial ischaemia (ST depression > 0.1 mV or elevation > 0.2 mV for > 1 min).

  4. Heart failure.

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.
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.