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临床试验/NCT05880615
NCT05880615已完成不适用

Opioid Reduced Anesthesia With Parasternal CATheters on Postoperative Delirium After Cardiac Surgery

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Number of Postoperative delirium (POD) assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) in the first 48 hours after surgery

研究概览

简要总结

PostOperative Delirium (POD) is the most common neuropsychiatric complication following cardiac surgery and may be related to morphine consumption. PostOperative Delirium (POD) prolongs hospital and intensive care unit (ICU) length of stay (LOS) and increases morbidity and mortality. No study has been conducted to demonstrate the effect of regional anesthesia using catheters inserted before sternotomy.

详细描述

This study investigate the effect of an enhanced recovery protocol using regional anesthesia on PostOperative Delirium (POD) onset.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age over 18
  • Admitte for scheduled cardiac surgery with sternotomy under cardiopulmonary bypass (CPB) for coronary artery bypass grafting (CABG), surgical correction of valve disease (aortic, mitral or tricuspid) or combined surgery (coronary artery bypass grafting (CABG) and valve replacement).

排除标准

  • Age over 85,
  • emergency surgery or heart transplant,
  • body mass index (BMI) more than 40 kg.m-2
  • reoperation
  • Renal insufficiency with glomerular filtration rate (GFR) less than 30 mL.min-1
  • left ventricular ejection fraction less than 30%
  • respiratory insufficiency with arterial pressure of oxygen less than 60 mmHg
  • hepatic insufficiency with prothrombin rate less than 30% or cirrhosis
  • chronic hyperglycemia not controlled
  • pregnancy
  • cognitive impairment chronic use of opioids or drug addiction
  • guardianship
  • allergy to locals anesthesics or any drugs

结局指标

主要结局

Number of Postoperative delirium (POD) assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) in the first 48 hours after surgery

时间窗: Hours: 48

assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Delirium is diagnosed when criteria 1 and 2 are positive, as well as criteria 3 or 4.

次要结局

  • Number of hypoxemia postoperative in the first 48 hours after extubation(Hours: 48)
  • Total morphine consumption within 48h after extubation(Hours: 48)
  • Pain at 24 hours and 48 hours postoperative(Hours: 24, 48)
  • postoperative nausea and vomiting(Hours: 48)
  • major complications (neurological, respiratory, cardiac, infectious)(Hours: 48)
  • Number of Ileus postoperative in the first 48 hours after extubation(Hours: 48)
  • mortality at 30 days after surgery(Day: 30)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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