Norepinephrine Versus Phenylephrine Infusion for Prophylaxis Against Spinal Induced Hypotension in Elderly Undergoing Hip Arthroplasty Under Spinal Anesthesia: A Randomized Comparative Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- mean heart rate
研究概览
简要总结
Various regimens were used for prevention of hypotension; most of these regimens included the use of vasopressors. Ephedrine is commonly used vasopressor for management and prophylaxis of hypotension; however, ephedrine is usually associated with tachycardia which increases oxygen consumption; thus, it might be potentially harmful in this special group of patients. Phenylephrine (PE) is another vasopressor which is characterized by α agonistic activity. PE had been the preferred vasopressor for prophylaxis against post-spinal hypotension especially in obstetric population.
it was reported that PE improved the intraoperative hemodynamic profile in elderly patients undergoing lower extremities orthopedic surgery under spinal anesthesia. PE (a pure α agonist) was reported to decrease cardiac output which limit its use in patients with compromised cardiac contractility; this fact makes the use of PE in elderly patients questionable. Norepinephrine (NE) is characterized by α agonistic and weak β agonistic activity; thus, NE is characterized by less cardiac depression compared to PE. NE was recently introduced for prophylaxis against post-spinal hypotension in obstetric anesthesia. In non-obstetric population, although, NE infusion effectively maintained patients hemodynamics during general anesthesia, its use during spinal anesthesia was not adequately evaluated in elderly population
详细描述
Preoperative fasting instructions are 6 hours for solid food, and clear fluid will be allowed up to 2 hours preoperative. Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and routine pre-medications (ranitidine 50 mg and midazolam 0.02 mg/kg slow IV) will be administrated. Baseline preoperative blood pressure will be recorded in the supine position as average of 3 reading with difference less than 5 mmHg.
Fluid management:
Before initiation of spinal anesthesia for all study patients, Electrical cardiometry device (ICON; Cardiotonic, Osypka; Berlin, Germany) will be applied to the patient through 4 electrodes at the following sites: Below the left ear, Above the midpoint of the left clavicle, Left mid-axillary line at level of the xiphoid process and 5 cm inferior to the third electrode. Stroke volume variability (SVV) will be measured while patient maintaining standard calm breathing at a rate of 6-8 breath/minute before the intrathecal injection. The patient with SVV more than 13% with be considered fluid responder 16 and will receive fluid bolus of 5 ml/kg ringer acetate over 10 minutes. The fluid bolus will be repeated till SVV less than 13%, then spinal anesthesia will be performed. After induction of spinal anesthesia maintenance fluid as 2ml/kg/hour of ringer acetate will be commenced.
Anesthetic management:
Spinal anesthesia will be performed in the sitting position at level of second and third or third and forth lumber interspaces with a 25-gauge spinal needle. After confirming cerebrospinal fluid flow, 10 mg of 0.5% hyperbaric bupivacaine plus 25 mcg fentanyl will be injected. The degree of sensory block (cold test by alcohol gauze) will be assessed in the study with a goal of T6-8 dermatomal level block. If spinal anesthesia failed, the patient will be excluded from the study and will be managed according to the attending anesthetist discretion, local expertise and clinical practice.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly patients (>65), ASA I-II-III, scheduled for hip joint surgery under spinal anesthesia
排除标准
- •Contraindication of spinal anesthesia (patient's refusal, infection at injection site, allergy, increased intracranial tension, coagulopathy, tight valvular lesion),
- •history of allergy to any of the study's drugs,
- •Patients with cardiac morbidities (impaired contractility with ejection fraction < 50%, heart block, arrhythmias),
- •hypertensive patients,
- •patients on beta blockers,
- •patient with hyperthyroidism
- •patients on monoamine oxidase inhibitors (MAOI) will be excluded from the study.
研究组 & 干预措施
norepinephrine group
patients will receive NE infusion at a starting of rate of 1 ml/min of 8 mcg/ml solution (prepared by diluting 4 mg NE in 500 ml normal)
干预措施: Norepinephrine (Drug)
phenylephrine
patients will receive PE infusion at a starting rate of 1 ml/min of 100 mcg/ml solution (prepared by diluting 10 mg of PE in 100 ml normal saline)
干预措施: phenylephrine (Drug)
结局指标
主要结局
mean heart rate
时间窗: for 45 minutes starting 2 minutes after induction of spinal anesthesia
beat per minute
次要结局
- incidence of bradycardia(for 45 minutes starting 2 minutes after induction of spinal anesthesia)
- incidence of reactive hypertension(for 45 minutes starting 2 minutes after induction of spinal anesthesia)
- Incidence of spinal induced hypotension(for 45 minutes starting 2 minutes after induction of spinal anesthesia)
研究者
Maha Mostafa Ahmad, MD
Principal Investigator
Kasr El Aini Hospital