El‐Shora 2018.
Methods | Parallel RCT Ethics committee: approved by the ethics committee Informed consents: written informed consents obtained Site: Egypt Setting: 2 centres from university hospital Dates of data collection: from March 2016 to March 2017 Funding: departmental/institutional Registration: PACTR201603001502110 (www.pactr.org). |
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Participants | 145 participants: mean age 43.5 years; sex distribution: 68 females and 77 males Inclusion criteria
Exclusion criteria
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Interventions |
Intervention
Comparator
Induction: midazolam, fentanyl, propofol, lidocaine, and pancuronium Maintenance: isoflurane and pancuronium Surgery: valve or CABG with CPB |
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Outcomes |
Relevant to this review
Others
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Notes | Correspondence: email sent 18 November 2018; study authors asked us to extract the information from the trial Conflict of interest: none DOI: 10.1055/s‐0038‐1668496 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Blocked stratified randomization was used to assign participants to 2 groups via 1:1 allocation Randomization sequence was generated randomly online using https://www.randomizer.org/; block size ranged from 4 to 6 participants. Randomization was stratified by participating centres |
Allocation concealment (selection bias) | Low risk | On the day before surgery, participants were sorted to 1 of the 2 groups based on blocked single‐blinded randomization |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Single‐blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Single‐blinded Cardiac anaesthesia specialist, not participating in data collection or patient follow‐up, performed the block designated for each participant (either bilateral thoracic paravertebral or thoracic epidural block) A nurse collected the data without pre‐knowledge of participants' assigned groups |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 participants were excluded from the paravertebral group: 3 for in‐hospital mortality and 2 for reoperation within 24 hours One participant in the epidural group died in hospital, but data for this participant were included in the analysis |
Selective reporting (reporting bias) | Low risk | All results were reported |
Other bias | Low risk | Groups well balanced “intention‐to‐treat” principle |