跳至主要内容
临床试验/CTRI/2025/09/094724
CTRI/2025/09/094724尚未招募不适用

An Observational Study on Effect of Dexmedetomidine Nebulization on postoperative Quality of Recovery in patients undergoing off-pump Coronary Artery Bypass Grafting

Non-Sponsored Academic Project1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年9月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
108
试验地点
1
主要终点
Postoperative Quality of Recovery Score using the QoR-40 Questionnaire at 24 and 48 hours post-extubation.

研究概览

简要总结

·       Coronary artery bypass graft (CABG) surgery remains a very important procedure for patients with narrowed coronary arteries either as a result of multiple vessel disease or following failed percutaneous intervention. It basically involves replacing the narrowed portions of the vessels with venous or arterial grafts.[1]

 ·       Most of these patients have advanced heart disease (New York Heart Association functional Class III and IV), in addition to some co-existing diseases such as diabetes and chronic renal disease. This makes intensive care after CABG a standard component of the treatment for most of these patients. Factors such as age, gender, hospital admission prior to surgery, the number of grafts and CPB time have variously been identified by many authors as determinants of Intensive Care Unit (ICU) length of stay (LOS) after CABG surgery. [1][2][3]. Long stay in the ICU has been found to result in increased hospital mortality, poor long-term prognosis, high morbidity and consequently increased cost and expenses. [4] .

·       Nebulized dexmedetomidine offers a variable alternative compared to IV dexmedetomidine, owing to drug deposition over a greater surface area [nasal, buccal, respiratory mucosa], resulting in better systemic absorption and prevention of postoperative delirium and agitation in OPCABG patients[8][9]

·       Delirium is experienced in 20% to 40% of the critically ill and up to 80% of mechanically ventilated patients [1–4]. It is a confusional state that has been described as a transient global disorder of cognition, awareness, and attention. It is associated with prolonged hospital length of stay and time on MV, deterioration in cognition, and increased morbidity and mortality causing additional health-care expenses [4][5]. Its pathophysiological mechanisms are highly heterogeneous—as perceived by the high number of risk factors —and have yet to be fully understood.

Quality of recovery after anaesthesia is an important measure of the early postoperative health status of patients. We attempted to develop a valid and reliable measure of quality of recovery after anaesthesia and surgery.[6]

·       We will conduct a study of OPCABG procedures done at the Fortis hospital, Bannerghatta, Bangalore, India over a 1 year period to determine the efficacy of dexmedetomidine nebulization in quality of recovery of these patients.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Elective OPCABG patients.
  • Age 40–75 years.
  • ASA II, III patients.
  • Consent to participate.

排除标准

  • Emergency surgery.
  • Severe hepatic or renal dysfunction.
  • AV block (Grade II/III) without pacemaker.
  • Chronic use of sedatives/opioids.
  • Allergy to dexmedetomidine.
  • Pre-existing psychiatric or neurological illness.

结局指标

主要结局

Postoperative Quality of Recovery Score using the QoR-40 Questionnaire at 24 and 48 hours post-extubation.

时间窗: Postoperative Quality of Recovery Score using the QoR-40 Questionnaire at 24 and 48 hours post-extubation.

次要结局

  • •Hemodynamic parameters (HR, BP) at 6, 12, 18, 24 hours(•Postoperative opioid consumption in first 24 hours.)

研究者

发起方
Non-Sponsored Academic Project
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Arya K S

Fortis Hospitals Limited

研究点 (1)

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