Hemodynamic Safety of Isobaric Levobupivacaine Versus Isobaric Bupivacaine for Subarachnoid Anesthesia in Patients Over 65 Years Undergoing Hip Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Compare hemodynamic effects from invasive systolic pressure, invasive diastolic pressure and mean blood pressure.
研究概览
简要总结
The altered hemodynamics, and therefore the arterial hypotension is the most prevalent adverse effect after subarachnoid anesthesia. The objective of the study was to determine the exact role of local anesthetic selection underlying spinal anesthesia-induced hypotension in the elderly patient. We conducted a descriptive, interventional pilot study to assess the hemodynamic impact of subarachnoid anesthesia with isobaric levobupivacaine versus isobaric bupivacaine for hip fracture surgery.
详细描述
- Objective of the trial 1.1. Main objective: Compare the hemodynamic effects from invasive systolic diastolic and mean blood pressures (ISBP, IDBP and IMBP) mesured in mmHg, arterial partial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg , arterial oxygen saturation (SatO2) measured in%, heart rate (HR / bpm) measured in beats per minute.
Other variables of interest will be: cardiac index (CI) mesured in litres per minute per square metre (L/min/m2), peripheral vascular resistance (PVR) medured in dynes/seconds/cm-5, partial arterial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg, pH (pH), arterial lactate (Lc) measured in mmol / L, arterial hemoglobin (Hb) measured in g/dl, partial oxygen saturation (SpO2%) measured in %.
1.2. Secondary objectives: Assess potential adverse events during surgery and 48 hours of surgery. Adverse events include adverse cardiovascular and respiratory rate, events related to both surgical and anesthetic techniques and exitus. 2. End points 2.1. Primary end point(s): hemodynamic variables invasive systolic blood pressure (ISBP) measured in mmHg invasive diastolic blood pressure (ISBP), measured in mmHg invasive mean blood pressure (IMBP), measured in mmHg arterial partial pressure of oxygen (PaO2) arterial partial pressure of carbon dioxide (PaCO2), measured in mmHg arterial oxygen saturation (SatO2) measured in% heart rate (HR / bpm) measured in beats per minute cardiac index (CI) mesured in litres per minute per square metre (L/min/m2). peripheral vascular resistance (PVR) mesured in dynes/seconds/cm-5 partial arterial pressure of oxygen (PaO2) measured in mmHg arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg pH (pH) arterial lactate (Lc) measured in mmol / L arterial hemoglobin (Hb) measured in g / dl partial oxygen saturation (SpO2%) measured in %.
2.1.1 Timepoint(s) of evaluation of this end point: entry into the operating room, after 30 minutes of anesthesia and at the end of anesthesia.
2.2. Secondary end point(s):
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
- None
入排标准
- 年龄范围
- 65 Years 至 120 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and Women over 65 years
- •Who meet the requirements in the pre-anesthetic to be treated with spinal anesthesia with levobupivacaine or bupivacaine, both with fentanyl,
- •Fitness: from I to IV, according to the American Society of Anesthesiologists (ASA),
- •Weight> 40 kg,
- •Height> 140 cm,
- •Body mass index (BMI) <50 kg/m2,
- •Pathology cardiovascular, respiratory, renal and endocrine-metabolic,
- •Provide written informed consent
排除标准
- •Patients with uncontrolled hypertension (non-invasive systolic blood pressure> 180 mmHg and / or non-invasive diastolic blood pressure > 110mmHg),
- •HR> 120 bpm,
- •SpO2 <90% on arrival in the operating room and the contraindication to perform neuraxial anesthesia (patient refusal, infection at the site of puncture or lancing different, neuromuscular degenerative disease, hypovolemia, coagulopathy or anticoagulant therapy, morbid obesity, and extreme increase in intracranial pressure).
研究组 & 干预措施
Levobupivacaine Hydrochloride 0,5%
The doses used of Levobupivacaine Hydrochloride 0.5% will be 6 mg and the dose of fentanyl 10 μg.
干预措施: Levobupivacaine Hydrochloride 0.5% (Drug)
isobaric bupivacaine 0,5%
The doses used of isobaric bupivacaine will be 6 mg and the dose of fentanyl 10 μg.
干预措施: Isobaric bupivacaine 0.5% (Drug)
结局指标
主要结局
Compare hemodynamic effects from invasive systolic pressure, invasive diastolic pressure and mean blood pressure.
时间窗: Intraoperative
The measurement of invasive systolic pressure and invasive diastolic pressure and mean blood pressure mesured in mmHg.
Compare hemodynamic effects from heart rate.
时间窗: Intraoperative
The measurement of heart rate in beats per minute.
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(48 hours of surgery)
研究者
ROSA HERRERA, MD
Principal Investigator
Hospital Clínico Universitario de Valencia