Hemodynamic and Cardiac Effects of Dexmedetomidine Versus Fentanyl by Intravenous Infusion as Adjuncts to General Anesthesia in Patients Undergoing Major Abdominal Cancer Surgeries.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- cardiac output (CO)
研究概览
简要总结
________________________________________
Background :
Major abdominal cancer surgery is among the most invasive procedures, often associated with extensive tissue damage, severe postoperative pain, and delayed recovery. Inadequate pain management can result in adverse physiological responses such as tachycardia, hypertension, prolonged immobility, and extended hospital stay. Moreover, poorly controlled pain may impair immune function and contribute to neuroendocrine, metabolic, gastrointestinal, and cardiopulmonary complications. Therefore, effective analgesia is essential to improve patient outcomes and recovery.
Multimodal analgesia has emerged as the gold standard for managing postoperative pain in major abdominal surgery. It integrates regional techniques (such as epidural or intrathecal analgesia), peripheral nerve blocks (e.g., transversus abdominis plane block), systemic opioids, and non-opioid agents including NSAIDs and acetaminophen. This approach minimizes surgical stress, maintains hemodynamic stability, and facilitates early ambulation and discharge.
Opioids, particularly fentanyl, are widely used as intrathecal adjuvants due to their rapid onset and favorable analgesic profile. However, selective alpha-2 adrenergic receptor agonists such as clonidine and dexmedetomidine are gaining attention for their sedative, analgesic, sympatholytic, and hemodynamic-stabilizing effects. Administered intrathecally, epidurally, or intravenously, they can enhance analgesia while reducing anesthetic requirements without causing profound sedation.
Conventional monitoring with heart rate and non-invasive blood pressure may overlook subtle variations in cardiac output. Electrical cardiometry (ICON®) provides continuous, non-invasive, beat-to-beat measurement of cardiac parameters and has been validated across different patient groups. Accordingly, the present study aims to compare intravenous dexmedetomidine and fentanyl as adjuvants to general anesthesia, focusing on their effects on hemodynamics and cardiac function in major abdominal cancer surgery using electrical cardiometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I- III, NYHA class I- II
- •Patients subjected to elective major abdominal cancer surgeries.
- •The enrolled age will be ≥ 18 years.
排除标准
- •Unfit for surgery
- •Patient refusal
- •Body mass index>40 kg/m2
- •ASA physical status IV-V, NYHA class III-IV.
- •Chronic opioid consumption
- •Contraindications to neuraxial block (coagulopathy, infection, or hematological disorders).
- •Pregnant women
- •Hypersensitivity to any of the used drugs
研究组 & 干预措施
Group D
Patients will receive Dexmedetomidineloading dose of 0.5 µg/kg over 10 minutes, followed by an infusion of 0.3-0.9 µg/kg/h.
干预措施: Dexmedetomidine (Drug)
Group F
Patients will receive Fentanyl loading dose of 1 µg/kg over 10 minutes, followed by an infusion of 0.5-1 µg/kg/h.
干预措施: Fentanyl (IV) (Drug)
结局指标
主要结局
cardiac output (CO)
时间窗: 24 hour postoperative
cardiac output (CO) measured using the non-invasive ICON® monitor
次要结局
未报告次要终点
研究者
Nariman Khaled Abd Elmontalb Hamed
residant doctor at Assiut university hospital
Assiut University