Proactive Low-Dose Norepinephrine to Reduce Intraoperative Fluid Administration in Patients at High-Risk for Postoperative Pulmonary Complications Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
研究概览
简要总结
Intraoperative hypotension is commonly treated with fluid administration; however, excessive fluid therapy may contribute to postoperative pulmonary complications. This randomized double-blind controlled trial evaluates whether proactive administration of fixed low-dose norepinephrine reduces intraoperative crystalloid administration while maintaining hemodynamic stability in high-risk patients undergoing laparoscopic abdominal surgery. One hundred and thirty patients will be randomized to receive either norepinephrine infusion (0.03 µg/kg/min) or placebo from induction until skin closure within a protocolized hemodynamic strategy guided by mean arterial pressure and pulse pressure variation.
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
- •Adult patients aged 18 years or older.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Scheduled for elective laparoscopic major abdominal surgery under general anesthesia with an expected duration greater than 2 hours.
- •Patients with ARISCAT score ≥ 45 indicating high risk for postoperative pulmonary complications.
排除标准
- •Known hypersensitivity to norepinephrine.
- •Severe left ventricular dysfunction with ejection fraction < 35%.
- •Significant cardiac arrhythmia.
- •Uncontrolled hypertension defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg.
- •End-stage renal disease.
- •Requirement for vasopressor support before induction of anesthesia.
- •Emergency surgery.
研究组 & 干预措施
Control Group
Participants will receive an equivalent volume normal saline infusion initiated immediately after induction of anesthesia and continued until skin closure within the same protocolized hemodynamic management strategy.
干预措施: Placebo (Other)
Norepinephrine Group
Participants will receive continuous norepinephrine infusion at a fixed dose of 0.03 µg/kg/min initiated immediately after induction of anesthesia and continued until skin closure within a protocolized hemodynamic management strategy.
干预措施: Norepinephrine (Drug)
结局指标
主要结局
未指定
次要结局
- Duration of Intraoperative Hypotension(From induction of anesthesia until skin closure (Intraoperative period))
- Number of Participants with Postoperative Pulmonary Complications(Within seven postoperative days)
- Number of Participants With Acute Kidney Injury(Within seven postoperative days)
- Duration of Rescue Norepinephrine Requirement(From induction of anesthesia until skin closure (Intraoperative period))
- Number of Participants Admitted to the Intensive Care Unit(Within seven postoperative days)
- Duration of Postoperative Hospital Stay(Within seven postoperative days)
- Number of Participants With Postoperative Surgical Complications(Within seven postoperative days)