Département d'Anesthésie et Réanimation Chirurgicale, CHU Brest, Brest, France
Université de Bretagne Occidentale, Brest, France.
BMJ Open. 2022 Apr 8;12(4):e058968. doi: 10.1136/bmjopen-2021-058968.
Incidence of delirium after cardiac surgery remains high and delirium has a significant burden on short-term and long-term outcomes. Multiple causes can trigger delirium occurence, and it has been hypothesised that sleep disturbances can be one of them. Preserving the circadian rhythm with overnight infusion of low-dose dexmedetomidine has been shown to lower the occurrence of delirium in older patients after non-cardiac surgery. However, these results remain controversial. The aim of this study was to demonstrate the usefulness of sleep induction by overnight infusion of dexmedetomidine to prevent delirium after cardiac surgery.
Dexmedetomidine after Cardiac Surgery for Prevention of Delirium is an investigator-initiated, randomised, placebo-controlled, parallel, multicentre, double-blinded trial. Nine centres in France will participate in the study. Patients aged 65 years or older and undergoing cardiac surgery will be enrolled in the study. The intervention starts on day 0 (the day of surgery) until intensive care unit (ICU) discharge; the treatment is administered from 20:00 to 08:00 on the next day. Infusion rate is modified by the treating nurse or the clinician with an objective of Richmond Agitation and Sedation Scale score from -1 to +1. The primary outcome is delirium occurrence evaluated with confusion assessment method for the ICU two times per day during 7 days following surgery. Secondary outcomes include incidence of agitation related events, self-evaluated quality of sleep, cognitive evaluation 3 months after surgery and quality of life 3 months after surgery. The sample size is 348.
The study was approved for all participating centers by the French Central Ethics Committee (Comité de Protection des Personnes Ile de France VI, registration number 2018-000850-22). The results will be submitted for publication in peer-reviewed journals.
NCT03477344.
心脏手术后谵妄的发生率仍然很高，谵妄对短期和长期结果有重大影响。多种原因可引发谵妄，有人假设睡眠障碍可能是其中之一。在非心脏手术后，夜间输注低剂量右美托咪定以维持昼夜节律已被证明可降低老年患者发生谵妄的风险。然而，这些结果仍存在争议。本研究旨在证明通过夜间输注右美托咪定诱导睡眠以预防心脏手术后谵妄的有效性。
心脏手术后用右美托咪定预防谵妄（Dexmedetomidine after Cardiac Surgery for Prevention of Delirium，DACOPED）是一项由研究者发起的、随机、安慰剂对照、平行、多中心、双盲试验。法国的 9 个中心将参与该研究。将招募年龄在 65 岁及以上且接受心脏手术的患者。干预措施从第 0 天（手术当天）开始，持续到重症监护病房（ICU）出院；治疗从第 1 天 20:00 持续到次日 08:00。治疗护士或临床医生根据治疗目标调整输液速度，使 Richmond 躁动镇静评分（Richmond Agitation and Sedation Scale，RASS）保持在-1 到+1 之间。主要结局是通过每天两次在 ICU 评估谵妄评估方法（Confusion Assessment Method for the ICU，CAM-ICU）评估术后 7 天内发生谵妄的情况。次要结局包括激越相关事件的发生率、自我评估的睡眠质量、术后 3 个月的认知评估和术后 3 个月的生活质量。样本量为 348 例。
该研究已获得所有参与中心的法国中央伦理委员会（Comité de Protection des Personnes Ile de France VI，注册号 2018-000850-22）的批准。研究结果将提交给同行评审期刊发表。
NCT03477344。
