Evaluation of Post-Induction Hypotension Treatment with PRAM Method Data in Gynecologic Oncology Cases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- "Is there a difference in the need for repeated doses of treatments to reach the target blood pressure in patients who develop post-induction hypotension?"
研究概览
简要总结
The goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases. The goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases.
详细描述
Post-induction hypotension is defined as hypotension that occurs within the first 20-30 minutes after general anesthesia induction or during the period between anesthesia induction and surgical incision. The global incidence rates are reported to be approximately 10.3%, with some studies indicating rates as high as 66.96%. Post-induction hypotension is associated with increased postoperative morbidity risks, such as acute kidney injury, transient tubular dysfunction, myocardial injury, and the need for postoperative intensive care. However, hypotension is a modifiable and preventable risk factor; its early detection and appropriate treatment can improve patient outcomes.
For this reason, investigators aimed to investigate the repeated dose requirements of alpha-adrenergic drugs, the recurrence of hypotension, and their effects on parameters observed via the MostCare monitor in patients undergoing major gynecologic oncologic surgeries during standard anesthesia induction and maintenance. This investigation focuses on patients experiencing a mean arterial pressure <65 mmHg or a >30% reduction in baseline systolic blood pressure within the first 30 minutes after induction or until surgical incision. Additionally, our secondary aim is to examine other parameters that may be associated with post-induction hypotension.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Above 18 years old
- •Operated for Gynecologic Oncological reasons
排除标准
- •Refusal to participate in the study
- •Additional spinal or epidural anesthesia
- •Dementia patients from whom consent could not be obtained
- •Atrial fibrillation with a rapid ventricular response
- •Patients with difficult ventilation and/or difficult intubation
- •Left ventricular ejection fraction (EF) below 30%
- •Severe aortic valve stenosis
- •Obesity (BMI >35)
- •Chronic beta-blocker use
研究组 & 干预措施
Ephedrine
When post-induction hypotension occurred patients were treated with 5 milligrams ephedrine in this group. If blood pressure does not reach desired levels, same dosage will be repeated 5 minutes later from administration. Maximum 3 doses will be applied and if hypotension ist persist the treatment will changed to rescue treatment.
干预措施: Ephedrine (Drug)
Noradrenaline
When post-induction hypotension occurred patients were treated with 5 micrograms noradrenaline in this group. If blood pressure does not reach desired levels, same dosage will be repeated 5 minutes later from administration. Maximum 3 doses will be applied and if hypotension ist persist the treatment will changed to rescue treatment.
干预措施: Noradrenalin (Drug)
结局指标
主要结局
"Is there a difference in the need for repeated doses of treatments to reach the target blood pressure in patients who develop post-induction hypotension?"
时间窗: First 30 minutes after anesthesia induction or time to skin incision
When hypotension is occured, researchers applied two treatment (e.g. Ephedrine and Norepinephrine) and assessed how many hypotension episodes occured after treatment
"Is there a difference in the time to reach the target blood pressure after treatments in patients who develop post-induction hypotension?"
时间窗: First 30 minutes after anesthesia induction or time to skin incision
When hypotension is occured, researchers applied two treatment (e.g. Ephedrine and Norepinephrine) and assessed that is there a difference in the time to reach the target blood pressure after treatments
次要结局
- Systemic vascular resistance (SVR)(First 30 minutes after anesthesia induction or time to skin incision)
- Arterial Elastance (Ea)(First 30 minutes after anesthesia induction or time to skin incision)
- Cardiac Output (CO)(First 30 minutes after anesthesia induction or time to skin incision)
- Stroke Volume (SV)(First 30 minutes after anesthesia induction or time to skin incision)
- Cardiac Cycle Efficiency (CCE)(First 30 minutes after anesthesia induction or time to skin incision)