Mona Momeni1, Céline Khalifa2, Guillaume Lemaire2, Christine Watremez2, Robert Tircoveanu2, Michel Van Dyck2, David Kahn2, Maria Rosal Martins2, Stefano Mastrobuoni3, Laurent De Kerchove3, Serge Henri Zango4, Luc-Marie Jacquet5. 1. Department of Anaesthesiology; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium. Electronic address: mona.momeni@uclouvain.be. 2. Department of Anaesthesiology; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium. 3. Department of Cardiac Surgery; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium. 4. Department of Epidemiology and Statistics; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium. 5. Department of Intensive Care Unit; Cliniques Universitaires Saint Luc, Université Cathlique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium.
Abstract
BACKGROUND:Postoperative delirium (POD) is a frequent complication in older patients. Dexmedetomidine might be effective in decreasing the incidence of POD. We hypothesised that adding low-dose rate dexmedetomidine infusion to a propofol sedation regimen would have fewer side-effects and would counteract the possible delirium producing properties of propofol, resulting in a lower risk of POD than propofol with placebo. METHODS: In this double-blind placebo-controlled trial, patients ≥60 yr old undergoing on-pump cardiac surgery were randomised 1:1 to the following postoperative sedative regimens: a propofol infusion and dexmedetomidine (0.4 μg kg-1 h-1) or a propofol infusion and saline 0.9% (placebo group). The study drug was started at chest closure and continued for 10 h. The primary endpoint was in-hospital POD, assessed using the Confusion Assessment Method and chart review method. RESULTS: POD over the course of hospital stay occurred in 31/177 (18%) and 33/172 (19%) patients in the dexmedetomidine and placebo arm, respectively (P=0.687; odds ratio=0.89; 95% confidence interval, 0.52-1.54). The incidence of POD in the intensive care alone, or on the ward alone, was also not significantly different between the groups. Subjects in the dexmedetomidine group spent less median time in a delirious state (P=0.026). Median administered postoperative norepinephrine was significantly higher in the dexmedetomidine group (P<0.001). One patient in the dexmedetomidine group and 10 patients in the placebo group died in the hospital. CONCLUSIONS: Adding low-dose rate dexmedetomidine to a sedative regimen based on propofol did not result in a different risk of in-hospital delirium in older patients undergoing cardiac surgery. With a suggestion of both harm and benefit in secondary outcomes, supplementing postoperative propofol with dexmedetomidine cannot be recommended based on this study. CLINICAL TRIAL REGISTRATION: NCT03388541.
RCT Entities:
BACKGROUND:Postoperative delirium (POD) is a frequent complication in older patients. Dexmedetomidine might be effective in decreasing the incidence of POD. We hypothesised that adding low-dose rate dexmedetomidine infusion to a propofol sedation regimen would have fewer side-effects and would counteract the possible delirium producing properties of propofol, resulting in a lower risk of POD than propofol with placebo. METHODS: In this double-blind placebo-controlled trial, patients ≥60 yr old undergoing on-pump cardiac surgery were randomised 1:1 to the following postoperative sedative regimens: a propofol infusion and dexmedetomidine (0.4 μg kg-1 h-1) or a propofol infusion and saline 0.9% (placebo group). The study drug was started at chest closure and continued for 10 h. The primary endpoint was in-hospital POD, assessed using the Confusion Assessment Method and chart review method. RESULTS: POD over the course of hospital stay occurred in 31/177 (18%) and 33/172 (19%) patients in the dexmedetomidine and placebo arm, respectively (P=0.687; odds ratio=0.89; 95% confidence interval, 0.52-1.54). The incidence of POD in the intensive care alone, or on the ward alone, was also not significantly different between the groups. Subjects in the dexmedetomidine group spent less median time in a delirious state (P=0.026). Median administered postoperative norepinephrine was significantly higher in the dexmedetomidine group (P<0.001). One patient in the dexmedetomidine group and 10 patients in the placebo group died in the hospital. CONCLUSIONS: Adding low-dose rate dexmedetomidine to a sedative regimen based on propofol did not result in a different risk of in-hospital delirium in older patients undergoing cardiac surgery. With a suggestion of both harm and benefit in secondary outcomes, supplementing postoperative propofol with dexmedetomidine cannot be recommended based on this study. CLINICAL TRIAL REGISTRATION: NCT03388541.
Authors: Palesa Motshabi-Chakane; Palesa Mogane; Jacob Moutlana; Gontse Leballo-Mothibi; Sithandiwe Dingezweni; Dineo Mpanya; Nqoba Tsabedze Journal: Int J Environ Res Public Health Date: 2021-12-03 Impact factor: 3.390