Continuous Norepinephrine Infusion Before General Anesthesia to Prevent Post-induction Hypotension in High-risk Patients Undergoing Major Noncardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 主要终点
- Incidence of post-induction hypotension
研究概览
简要总结
The investigators aimed to investigate the effects of continuous infusion of norepinephrine before and after general anesthesia induction on the occurrence of post-induction hypotension.
详细描述
Intraoperative hypotension is common after general anesthesia induction and is associated with adverse postoperative events. Norepinephrine is one of the most applied vasopressors in clinical to treat intraoperative hypotension. Due to the absence of effective measures for predicting intraoperative hypotension, infusing norepinephrine before and during anesthesia induction may reduce intraoperative hypotension. There is currently a lack of research regarding whether continuous norepinephrine infusion before and during the induction of general anesthesia can mitigate or prevent post-induction hypotension. The investigators aim to investigate the effects of continuous infusion of norepinephrine before and after general anesthesia induction on the occurrence of post-induction hypotension.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged above 65 years or those above 45 years with at least one of the following preoperative cardiovascular diseases: essential hypertension, coronary artery disease, stroke, or type I/II diabetes mellitus.
- •Patients who will receive major noncardiac surgery as open or laparoscopic abdominal surgeries with an anticipated operative duration over two hours, including gastrointestinal, liver, pancreatic, bladder, and uterine/adnexal surgeries.
排除标准
- •Patients who declined to participate in the present study.
- •Patients enrolled in another ongoing clinical study.
- •Patients with systolic arterial pressure (SAP) below 90 mmHg or above 160 mmHg, or heart rate (HR) over 100 beats per minute (bpm) before anesthesia induction.
- •Patients who have experienced any type of shock within 30 days before surgery.
- •Patients with circulatory instability require continuous or intermittent positive inotropic and/or vasopressors within 24 hours before surgery.
- •Patients receive continuous or intermittent intravenous antihypertensive agents within 24 hours before surgery.
- •Patients underwent coronary artery bypass grafting, coronary angiography, or coronary stenting within 180 days before surgery.
- •Patients who were diagnosed with new-onset tachyarrhythmia within 180 days before surgery, such as atrial fibrillation, atrial flutter, and premature ventricular contractions.
- •Patients with preoperative alanine aminotransferase >80 international units and/or glomerular filtration rate < 80 ml/min within the 180 days before surgery.
- •Patients are ineligible for intraoperative invasive radial artery blood pressure monitoring.
- •Patients with a known history of allergy to norepinephrine.
- •Patients who were planned for rapid sequence induction.
- •Patients who were scheduled for awake tracheal intubation.
- •Patients who were scheduled for double-lumen endotracheal intubation. Pregnant or lactating patients.
研究组 & 干预措施
Norepinephrine
The interventional group will receive a continuous infusion of norepinephrine 5 minutes (0.01μg/kg*min) before anesthesia induction until skin incision.
干预措施: Norepinephrine Hydrochloride (Drug)
Placebo
the placebo group will receive a continuous infusion of normal saline (10 ml/h) 5 minutes before anesthesia induction until skin incision.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of post-induction hypotension
时间窗: From induction of general anesthesia to skin incision (up to one hour from induction of general anesthesia)
Hypotension: mean arterial pressure (MAP) \<65 mmHg
次要结局
- Incidence of the following abnormal vital signs(from the end of surgery until leaving the post-anesthesia care unit (up to four hours from the end of surgery))
- Postoperative major adverse cardiac events(Within 30 days after surgery)
研究者
Yuan Chang
Principal Investigator
First Affiliated Hospital of Kunming Medical University