Ren 2020.
Study characteristics | ||
Methods | Setting: single‐centre, China Design: RCT, 2 arms, open‐label, blind endpoint Start date: August 2017 Completion date: December 2018 |
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Participants | 90 men and women randomised: experimental GA = 48, comparator CSA = 42; procedure interrupted in GA = 8 and CSA = 7; 0 lost to follow‐up, 90 analysed Mean age: CSA = 69.19 (SD 6.46) years and GA = 69.21 (SD 5.78) years Gender (men/women): 50/40 Mean NIHSS score: 14 (score range: 11–16) Mean ASPECTS: 9 (score range: 8–10) ASA I/II/III: CSA = 5/15/22 and GA = 4/19/25 Mean BMI (kg/m²): CSA = 24.91 (SD 2.59) and GA = 23.84 (SD 2.02) 4 (9.52%) participants converted from CSA to GA 71 (78.8%) participants received IV r‐tPA before EVT Diagnostic criteria: AIS with LVO in anterior cerebral circulation Inclusion criteria
Exclusion criteria
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Interventions | Experimental: GA
Comparator: CSA
Blood pressure was routinely recorded non‐invasively at 3‐minute intervals The anaesthesiologist performed GA if the procedure was not possible due to the restlessness of participants in the CSA group At the end of the surgery, recanalisation was classified by the neuroradiologist according to the mTICI perfusion grade. After removal of the tracheal intubation, all participants were transferred to the SU or ICU for ≥ 24 hours and cared for by an expert neurologist Vasoactive drugs such as phenylephrine, ephedrine, atropine, urapidil, and nimodipine were used to keep blood pressure and heart rate fluctuation stable at the target values. Phenylephrine was the most commonly used vasopressor, and nimodipine was the most commonly used agent for hypotension Excluded medications: not reported |
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Outcomes | Primary outcome (specified)
Primary outcome (collected)
Secondary outcomes (specified)
Secondary outcomes (collected)
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Notes | Conflicts of interest: quote: "The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest". Funding: quote: "self' (describe at ChiCTR‐IPR‐16008494) Protocol: ChiCTR‐IPR‐16008494 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "a computer‐generated randomisation table was used by an independent anaesthesia assistant to allocate patients into two groups: the CSA group (n = 42) and the GA group (n = 48)". |
Allocation concealment (selection bias) | Unclear risk | Details not fully described. Quote: "a computer‐generated randomisation table was used by an independent anaesthesia assistant to allocate patients into two groups: the CSA group (n = 42) and the GA group (n = 48)". |
Blinding of participants and personnel (performance bias) | High risk | Although the authors described that personnel were blinded, we judged it as a high risk of bias due to the nature of the intervention. Quote: "our anaesthesia team included an attending anaesthesiologist and an anaesthesiologist assistant who were both blinded to group allocation". |
Blinding of outcome assessment (detection bias) | Low risk | Quote: "all of the investigators who assessed primary and secondary outcomes were blinded to group allocation". |
Incomplete outcome data (attrition bias) | Low risk | 0 losses and crossovers occurred in 4 (9.52%) participants from CSA to GA, but they were analysed as ITT. |
Selective reporting (reporting bias) | High risk | We noted several changes from what was reported in the protocol against the trial publication for the inclusion and exclusion criteria, and primary and secondary outcomes. |
Other bias | High risk | Authors changed study objective. Protocol stated the objective was to observe the effect of different concentrations and ways of giving dexmedetomidine with remifentanil for people with craniocerebral disease interventional therapy under GA; however, the trial published results regarding the effect of CSA vs GA on outcomes in people undergoing mechanical thrombectomy for AIS. |