跳至主要内容
临床试验/NCT05849597
NCT05849597招募中3 期

Dexmedetomidinine in the Prevention of Postoperative Delirium in the Intensive Care Unit After Cardiac Surgery

University of Novi Sad1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
200
试验地点
1
主要终点
Occurrence of postoperative delirium

研究概览

简要总结

This is a prospective, randomized, single blinded, controlled clinical trial designed to compare the clinical effects of sedation with dexmedetomidine versus propofol in patients undergoing cardiac surgery.

详细描述

The study will include adult patients of both sexes scheduled for elective cardiac surgery with the use of cardiopulmonary bypass (including coronary artery bypass grafting, valve repair/replacement, and combined).

The patients included in the study will be randomized in 1:1 ratio using computer generated numbers into two groups. The first group of patients, upon arrival to the intensive care unit will be sedated with continuous dexmedetomidine infusion in doses 0.2-0.7 mcg/kg/h. Dexmedetomidine infusion will be discontinued before weaning from mechanical ventilation and extubation. The second group of patients, upon arrival to the intensive care unit will be sedated with continuous propofol infusion in doses 1-2 mg/kg/h. Propofol infusion will also be discontinued before weaning from mechanical ventilation and extubation.

Sedation level will be assessed using Richmond Agitation and Sedation Scale (RASS) every two hours. Postoperative analgesia will be managed according to protocol (opioid analgesics, non-steroid anti-inflammatory drugs, paracetamol), with pain level assessment using visual analog scale (0 - no pain; 10 - unbearable pain).

The following data will be registered: age, sex, body mass index (BMI), hemoglobin, heart rate, and LVEF. Among the postoperative parameters, the following will registered: duration of mechanical ventilation (in hours), extubation time, ICU and hospital length of stay (in days), postoperative hemoglobin, blood product transfusion rates, occurrence of atrial fibrillation and assessment of delirium. Assessment of delirium will be performed using the confusion assessment method for intensive care unit (CAM-ICU) every 12 hours during five postoperative days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • patients undergoing open heart surgery with the use of cardiopulmonary bypass (including coronary artery bypass grafting, valve repair/replacement, and combined)
  • left ventricular ejection fraction (LVEF) >40%.

排除标准

  • preoperative atrial fibrillation
  • previous history of interventionally treated arrhythmias
  • second and third degree atrioventricular block
  • bradycardia with heart rate ≤50/min
  • pacemaker
  • renal or hepatic insufficiency
  • emergency procedures
  • history of serious mental illness, delirium, and severe dementia

研究组 & 干预措施

Dexmedetomidine

Experimental

Evaluate the effects of dexmedetomidine for sedation of patients in the intensive care unit after open heart surgery

干预措施: Dexmedetomidine (Drug)

Propofol

Active Comparator

Compare the clinical outcomes of the experimental group with the standard of care, i.e. sedation with propofol

干预措施: Propofol (Drug)

结局指标

主要结局

Occurrence of postoperative delirium

时间窗: 5 days

Assessment of delirium will be performed using the confusion assessment method for intensive care unit (CAM-ICU) at any time in the first five days after surgery

次要结局

  • Hospital length of stay(30 days)
  • ICU length of stay(30 days)
  • MV duration(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mihaela Preveden

Research Assistant

University of Novi Sad

研究点 (1)

Loading locations...

相似试验