Fractionated Spinal Anesthesia With Combined Isobaric and Hyperbaric Bupivacaine Toward Safer Anesthesia for Elderly Hip Fracture Patients: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Incidence of intraoperative hypotension
研究概览
简要总结
This prospective randomized controlled study will be conducted to compare the effect of fractionated SA using isobaric and hyperbaric bupivacaine with fractionated SA using hyperbaric bupivacaine and the conventional SA on hemodynamic instability in orthogeriatric patients undergoing hip fracture surgeries.
详细描述
Hip fractures are one of the most common reasons for elderly patients to present to the emergency department and require urgent surgery. Despite the debate regarding the preferred type of anesthesia in the elderly population, spinal anesthesia has shown the advantage of the simplicity of the technique, the better analgesic profile, the lower incidence of thromboembolic events and lower hospital stay. Hemodynamic stability should be considered as a primary intraoperative target. In pursuit of optimizing spinal anesthesia, this study proposed that fractionated SA by sequential administration of low doses of isobaric and hyperbaric bupivacaine can minimize hemodynamic instability while leveraging the advantages of both solutions when compared with fractionated SA using hyperbaric bupivacaine or the conventional SA technique.
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
- Double (Participant, 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 of both gender aged 65 years or more with American Society of Anesthesiologists (ASA) Physical Status I-III, who were scheduled for hip fracture surgeries under Spinal anesthesia
排除标准
- •Patients declined to participate in the trial.
- •Patients on anticoagulation therapy.
- •Patients planned for general anesthesia.
- •Patients with atrial fibrillation.
- •Allergies or hypersensitivity to local anesthetic drugs.
- •Spinal cord deformities.
- •Infection that contraindicate SA.
- •Preoperative motor and sensory deficits
研究组 & 干预措施
Conventional SA group
patients will receive the conventional SA bolus dose of hyperbaric bupivacaine and fentanyl.
干预措施: Conventional SA group (Procedure)
Fractionated SA with isobaric and hyperbaric bupivacaine
patients will receive fractionated SA in two doses first dose of hyperbaric bupivacaine with fentanyl followed after 90 seconds by the second dose of isobaric bupivacaine.
干预措施: Fractionated SA with isobaric and hyperbaric bupivacaine (Procedure)
Fractionated SA with hyperbaric bupivacaine group
patients will receive fractionated SA in two doses of hyperbaric bupivacaine and fentanyl, two thirds of the dose will be given firstly followed by the last third after 90 seconds.
干预措施: Fractionated SA with hyperbaric bupivacaine (Procedure)
结局指标
主要结局
Incidence of intraoperative hypotension
时间窗: MAP will be measured intraoperatively before spinal anesthesia (SA), immediately after administering SA and subsequently at regular intervals 5, 10, 20, 30, 60, 75, 90 minutes, and then every 30 minutes till the end of surgery.
Intraoperative hypotension is defined as the drop of systolic blood pressure (SBP) by 25% of the basal reading or the drop of MAP below 65 mmHg.
次要结局
- Incidence of bradycardia.(HR will be measured intraoperatively before spinal anesthesia (SA), immediately after administering SA and subsequently at regular intervals 5, 10, 20, 30, 60, 75, 90 minutes, and then every 30 minutes till the end of surgery.)
- Vasopressor requirements.(intraoperatively after spinal anesthesia till the end of surgical intervention)
- Postoperative pain score(immediately post operatively then every 30 minutes up to 2 hour)
- Time to first rescue analgesia(post operative .. time interval from the end of surgery until need of rescue analgesia)
研究者
Mai Salah Salem
Lecturer of anesthesia, Surgical intensive care and pain medicine
Tanta University