Badner 2000.
Methods | Single‐centre RCT | |
Participants |
Setting: McMaster University, Canada Inclusion criteria: ASA I‐III patients, age > 18 years, presenting for elective carotid endarterectomy Exclusion criteria: patients were excluded if they had received an anaesthetic within 30 days before their scheduled surgery, if they were currently taking medications known to affect plasma homocysteine (vitamins B12 and B6, folic acid, penicillamine, methotrexate, azaurodine, isoniazid, cycloserine, phenelzine, or procarbazine); if they were vitamin B12 or folate deficient, malnourished or cirrhotic; or if they had a pace‐maker or left bundle branch block on electrocardiogram (ECG) Participant numbers: 90 randomly assigned; 86 analysed |
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Interventions | Intervention: anaesthesia was maintained with opioid (fentanyl or sufentanil), isoflurane, and nitrous oxide/oxygen (inspired nitrous oxide 50%). Control: anaesthesia was maintained with opioid (fentanyl and sufentanil), isoflurane, and oxygen/air. | |
Outcomes | Other outcomes: Myocardial ischaemia | |
Notes | Four patients did not complete the 48‐h study period, two required reoperation for hematoma formation (both non‐nitrous oxide), and two patients had Holter monitoring inappropriately discontinued (one from each group). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomized using a computer‐generated random number table." |
Allocation concealment (selection bias) | Unclear risk | No details given. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | This was not reported. |
Blinding of outcome assessment (detection bias) Inhospital case fatality rate/length of stay | Unclear risk | — |
Blinding of outcome assessment (detection bias) Complications | Low risk | Quote: "Myocardial ischemia was determined by a blinded technician." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups. |
Selective reporting (reporting bias) | Low risk | All outcomes described in methods section reported. |
Other bias | Low risk | No other potential sources of bias were detected. |