跳至主要内容
临床试验/CTRI/2025/03/083309
CTRI/2025/03/083309尚未招募4 期

To compare the effectiveness of Dexmedetomidine with Melatonin vs Dexmedetomidine alone in preventing postoperative delirium in elderly patients undergoing cardiac surgery -A prospective randomised interventional study.

Sree chitra tirunal institute for medical sciences and technology1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2025年4月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
134
试验地点
1
主要终点
To compare the effectiveness of Dexmedetomidine with Melatonin vs Dexmedetomidine alone in preventing incidence of postoperative delirium in elderly patients undergoing cardiac surgery and to identify the agent that provides superior delirium prevention outcomes.

研究概览

简要总结

Delirium is a brain dysfunction characterized by an acute onset and fluctuating disturbance in consciousness, attention and cognition. Postoperative delirium (POD) is a neuropsychiatric syndrome characterized by disturbances of cognition, attention, consciousness, or perception with  acute onset and fluctuating course.The incidence of POD in older individuals is 15% to 53%, most frequently occurring in the first 3 days after the procedure.Postoperative delirium (POD) is associated with poor outcomes, including prolonged hospital stay, increased costs, and worsened quality of life.Current interventions for delirium prevention primarily involve recognition and improvement of modifiable risk factors besides active treatment of original diseases, but the curative effect is not obvious. Within current guidelines, no pharmacological methods were recommended for delirium prevention. After cardiac surgery, delirium remains the most common neurocognitive complication with an incidence of  6-46% . Patients who have cardiac surgery are at higher risk of postoperative delirium than those following noncardiac surgery because of a higher prevalence of risk factors, such as older age, cerebrovascular disease, diabetes mellitus, and renal disease and receipt of cardiopulmonary bypass.Dexmedetomidine and melatonin have both shown promise in preventing delirium in various patient populations. However, there is a lack of comparative studies evaluating the efficacy of these two agents in cardiac surgery patients. This research proposal outlines a comparative study between dexmedetomidine and melatonin in preventing postoperative delirium in cardiac surgery patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 1.Age more than or equal to 60 years 2.Patients scheduled for elective cardiac surgery.

排除标准

  • 1.Patient with current/past history of mental illness, neuropsychiatric disease, h/o substance abuse, alcohol dependence.
  • 2.History of known allergy to the study drugs.
  • 3.Patients who had taken drugs which may cause sedation in last 12hours.
  • 4.History of intake of antiepileptics, antianxiety drugs, hypnotics, antidepressants or antipsychotics.
  • 5.H/o OSA and diagnosed sleep disorders.
  • 6.Redo-surgeries.
  • 7.Hemodynamically unstable patients.
  • 8.Patients refusing consent for study.

结局指标

主要结局

To compare the effectiveness of Dexmedetomidine with Melatonin vs Dexmedetomidine alone in preventing incidence of postoperative delirium in elderly patients undergoing cardiac surgery and to identify the agent that provides superior delirium prevention outcomes.

时间窗: Delirium will be assessed using Confusion assessment method for the ICU (CAM-ICU) one day before surgery and on postoperative day 0, 1 and 2. Postoperative delirium will be defined by fulfilment of the CAM-ICU criteria which includes 1) acute onset and fluctuating symptoms, 2) inattention, and either 3) an altered level of consciousness or 4) disorganised thinking

次要结局

  • 1.To compare the differences in the duration of delirium between patients receiving dexmedetomidine with melatonin & dexmedetomidine alone.(2.To compare duration of mechanical ventilation & ICU stay between two groups.)

研究者

发起方
Sree chitra tirunal institute for medical sciences and technology
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Haritha Ravindran

Sree chitra tirunal institute for medical sciences and technology

研究点 (1)

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