Minerva anestesiologica · 2025
Pregabalin versus dexmedetomidine for prevention of delirium after cardiac surgery: a randomized double-blind non-inferiority trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Morsy Islam, Bakr Doha M, Abdelwahab Esraa H, Abo Elkhier Ahmed E, Abdallah Mai K, Rehab Osama M
Аннотация
BACKGROUND: The incidence of postoperative delirium (POD) has been reported to be up to 53% following cardiac surgery. This trial aimed to determine the effect of perioperative administration of pregabalin versus dexmedetomidine (DEX) on the POD incidence in elderly patients planned for cardiac surgery, together with other secondary outcome measures. We hypothesized that pregabalin, with its sedative analgesic effects, would be non-inferior to DEX regarding POD prevention.
METHODS: This randomized, double-blind, parallel-controlled, non-inferiority trial was conducted on 60 elderly cases planned for cardiac surgery. The cases were randomly assigned equally into a pregabalin group (group P) and DEX group (group D). The non-inferiority margin was set to 20%. The primary outcome was the POD incidence. Secondary endpoints included analgesic profile, sedation scale, and adverse events.
RESULTS: Pregabalin was non-inferior to DEX regarding the reduction in the incidence of POD (17.86% vs. 21.43%; risk difference, -3.6%; two-sided 95% CI, - 24.25% to 17.41%; meeting non-inferiority criteria). POD onset and duration showed an insignificant difference between the groups. The total morphine consumption in the first 48 hours after surgery was significantly lower in group P (25.64±7.04 mg) than in group D (34.66±9.25 mg; 95% CI, -13.42 to -4.61; P=0.0001). Both groups were insignificantly different regarding the visual analog scale score, sedation agitation scale measurements, recovery time, and adverse events.
CONCLUSIONS: Pregabalin is non-inferior to DEX in terms of delirium prevention after cardiac surgeries with comparable sedative effects, but it has a superior analgesic profile in the form of a significantly lower 48-hour opioid dose.
METHODS: This randomized, double-blind, parallel-controlled, non-inferiority trial was conducted on 60 elderly cases planned for cardiac surgery. The cases were randomly assigned equally into a pregabalin group (group P) and DEX group (group D). The non-inferiority margin was set to 20%. The primary outcome was the POD incidence. Secondary endpoints included analgesic profile, sedation scale, and adverse events.
RESULTS: Pregabalin was non-inferior to DEX regarding the reduction in the incidence of POD (17.86% vs. 21.43%; risk difference, -3.6%; two-sided 95% CI, - 24.25% to 17.41%; meeting non-inferiority criteria). POD onset and duration showed an insignificant difference between the groups. The total morphine consumption in the first 48 hours after surgery was significantly lower in group P (25.64±7.04 mg) than in group D (34.66±9.25 mg; 95% CI, -13.42 to -4.61; P=0.0001). Both groups were insignificantly different regarding the visual analog scale score, sedation agitation scale measurements, recovery time, and adverse events.
CONCLUSIONS: Pregabalin is non-inferior to DEX in terms of delirium prevention after cardiac surgeries with comparable sedative effects, but it has a superior analgesic profile in the form of a significantly lower 48-hour opioid dose.