Comparison of Low-Dose Versus Standard-Dose Hyperbaric Bupivacaine in Spinal Anesthesia: Hemodynamic Stability and Recovery Profile in Elderly Patients Undergoing Lower Limb Orthopedic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incidence of Intraoperative Hypotension
研究概览
简要总结
The goal of this randomized controlled trial is to determine whether low-dose hyperbaric bupivacaine provides better hemodynamic stability and postoperative recovery compared with standard-dose hyperbaric bupivacaine in elderly patients undergoing lower limb orthopedic surgery under spinal anesthesia.
The main questions it aims to answer are:
- Does low-dose hyperbaric bupivacaine reduce the incidence of intraoperative hypotension and bradycardia compared with standard-dose hyperbaric bupivacaine?
- Does low-dose hyperbaric bupivacaine improve postoperative recovery profile compared with standard-dose hyperbaric bupivacaine?
Researchers will compare elderly patients receiving low-dose hyperbaric bupivacaine with those receiving standard-dose hyperbaric bupivacaine to determine whether a lower intrathecal dose improves cardiovascular stability and recovery without compromising the effectiveness of spinal anesthesia.
Participants will:
- Provide written informed consent before enrollment.
- Undergo elective lower limb orthopedic surgery under spinal anesthesia.
- Be randomly assigned to receive either low-dose or standard-dose hyperbaric bupivacaine.
- Have their blood pressure, heart rate, and other vital signs monitored throughout the surgical procedure.
- Be assessed for intraoperative hypotension and bradycardia according to predefined study criteria.
- Be evaluated for postoperative recovery parameters, including motor recovery and readiness for postoperative recovery and mobilization.
The information obtained from this study may help identify a safer and more effective spinal anesthetic technique for elderly patients undergoing orthopedic surgery.
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)
盲法说明
Participants will be unaware of the group allocation. Postoperative outcome assessment and data collection will be performed by an investigator blinded to treatment allocation. The anesthesiologist administering spinal anesthesia will not be blinded because of the preparation and administration of different doses of hyperbaric bupivacaine.
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
- •Male or female patients aged 65 years and above.
- •Patients scheduled for elective lower limb orthopedic surgery under spinal anesthesia.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Patients willing to participate and provide written informed consent.
排除标准
- •Refusal to participate in the study.
- •Contraindications to spinal anesthesia (e.g., infection at puncture site, coagulopathy, severe hypovolemia, raised intracranial pressure).
- •Known hypersensitivity or allergy to bupivacaine.
- •Severe valvular heart disease.
- •Significant cardiac arrhythmias.
- •Uncontrolled hypertension.
- •Severe hepatic or renal impairment.
- •Pre-existing neurological disorders affecting lower limb motor or sensory function.
- •Severe spinal deformity or previous lumbar spine surgery interfering with spinal anesthesia.
- •Cognitive impairment or inability to provide informed consent.
- •Emergency orthopedic procedures.
研究组 & 干预措施
Standard-Dose Hyperbaric Bupivacaine
Participants randomized to this group will receive standard-dose hyperbaric bupivacaine for spinal anesthesia before elective lower limb orthopedic surgery. Hemodynamic parameters and postoperative recovery outcomes will be assessed according to the study protocol.
干预措施: Standard-Dose Hyperbaric Bupivacaine (Drug)
Low-Dose Hyperbaric Bupivacaine
Participants randomized to this group will receive low-dose hyperbaric bupivacaine for spinal anesthesia before elective lower limb orthopedic surgery. Hemodynamic parameters and postoperative recovery outcomes will be assessed according to the study protocol.
干预措施: Low-Dose Hyperbaric Bupivacaine (Drug)
结局指标
主要结局
Incidence of Intraoperative Hypotension
时间窗: From administration of spinal anesthesia until completion of surgery
Occurrence of intraoperative hypotension following spinal anesthesia, defined as a decrease in systolic blood pressure greater than 20% from baseline or systolic blood pressure less than 90 mmHg requiring intervention.
次要结局
- Time to First Ambulation(Within the first 24 hours after surgery)
- Incidence of Intraoperative Bradycardia(From administration of spinal anesthesia until completion of surgery.)
- Time to Complete Motor Recovery(From completion of surgery until achievement of Bromage Score 0, assessed up to 24 hours postoperatively)
- Postoperative Recovery Profile(From completion of surgery until discharge from the post-anesthesia care unit (PACU), assessed up to 24 hours postoperatively)
研究者
Muhammad Shaheryar Bashir
Principal Investigator
Mayo Hospital Lahore