Hemodynamic safety of isobaric levobupivacaine versus isobaric bupivacaine for subarachnoid anesthesia in patients over 65 years old undergoing hip fracture surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Invasive systolic arterial pressure (PASI), invasive diastolic arterial pressure (PADI), invasive mean arterial pressure (PAMI), arterial oxygen saturation (SatO2) measured in %, heart rate (HR) measured in beats per minute (bpm), and partial oxygen saturation (SpO2%) measured in %.
研究概览
简要总结
The primary objective of the study will be to compare the hemodynamic effects of isobaric levobupivacaine and isobaric bupivacaine, both in combination with fentanyl, in patients aged 65 years or older undergoing hip fracture surgery. This comparison will be based on invasive systolic arterial pressure (PASI), invasive diastolic arterial pressure (PADI), invasive mean arterial pressure (PAMI), arterial oxygen saturation (SatO2) measured in %, and heart rate (HR) measured in beats per minute (bpm).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged 65 years or older
- •Underwent hip fracture surgery
- •Eligible for intradural anesthesia with levobupivacaine and fentanyl or bupivacaine and fentanyl, as determined in the pre-anesthetic visit.
- •Physical status classified between I and IV according to the American Society of Anesthesiologists (ASA).
- •Weight > 40 kg and Height > 140 cm. Body mass index (BMI) < 50 kg/m²
- •Presence of cardiovascular, respiratory, renal, or endocrine-metabolic condition
- •Provided informed consent to participate in the study.
排除标准
- •Uncontrolled arterial hypertension (non-invasive systolic blood pressure >180 mmHg and/or non-invasive diastolic blood pressure >110 mmHg).
- •Heart rate (HR) >120 bpm
- •Oxygen saturation (SpO2) <90% upon arrival at the operating room
- •Contraindications to neuraxial anesthesia, including: Patient refusal, Infection at or near the puncture site, Degenerative neuromuscular disease, Hypovolemia, Coagulopathy or anticoagulant treatment, Extreme morbid obesity or Increased intracranial pressure.
结局指标
主要结局
Invasive systolic arterial pressure (PASI), invasive diastolic arterial pressure (PADI), invasive mean arterial pressure (PAMI), arterial oxygen saturation (SatO2) measured in %, heart rate (HR) measured in beats per minute (bpm), and partial oxygen saturation (SpO2%) measured in %.
Invasive systolic arterial pressure (PASI), invasive diastolic arterial pressure (PADI), invasive mean arterial pressure (PAMI), arterial oxygen saturation (SatO2) measured in %, heart rate (HR) measured in beats per minute (bpm), and partial oxygen saturation (SpO2%) measured in %.
次要结局
- Cardiac index (CI), peripheral vascular resistance (PVR), partial arterial oxygen pressure (PaO2), and partial arterial carbon dioxide pressure (PaCO2) measured in mmHg, pH, arterial lactate (Lc) measured in mmol/L, and arterial hemoglobin (Hb) measured in g/dL.
- Adverse events during surgery and up to 48 hours after the surgical procedure will include: cardiovascular and respiratory adverse events, associated with the surgical technique and with the anesthetic technique.
研究者
Rosa Mª Herrera Castro
Scientific
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA