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临床试验/NCT07520695
NCT07520695已完成2 期

Impact of Two Minutes Delayed Supine Position Post-Spinal Compared With Immediate Supine Position in Geriatric Patients Undergoing Repair of Fracture Neck of Femur: A Randomized Controlled Trial

Sohar Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Incidence of hypotension after spinal anesthesia in both groups

研究概览

简要总结

Background: Geriatric patients undergoing femoral neck of fracture (FNOF) repair are highly susceptible to spinal anesthesia-induced hypotension. This study examines whether a two-minute delayed supine position after spinal injection reduces this risk. Methods: Ninety patients aged ≥65 years undergoing FNOF surgery under spinal anesthesia were randomized into two groups. Group D remained seated for two minutes post-spinal injection; Group I was positioned supine immediately. Hemo-dynamic parameters, recorded as primary outcomes, other parameters like vasopressor use, maximum sensory level achieved, duration of surgery, and fluid administration as secondary outcomes.

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
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Geriatric patients (aged 65 years and above) scheduled for surgical fixation of fracture neck of femur under spinal anesthesia were eligible for inclusion

排除标准

  • Contraindications to spinal anesthesia (e.g., coagulopathy, local infection, etc.).
  • Haemodynamic instability or baseline systolic BP < 90 mmHg.
  • Allergy to study medications.
  • Morbidly obese patients (BMI>40).

研究组 & 干预措施

putting patients immediately in a supine position after spinal anesthesia

Active Comparator

干预措施: immediate supine position (Procedure)

keeping the patient 2 minutes setting after spinal anesthesia

Experimental

干预措施: 2 minutes setting post spinal anesthesia (Procedure)

结局指标

主要结局

Incidence of hypotension after spinal anesthesia in both groups

时间窗: Postprocedural for 2 hours

Hypotension is defined by systolic blood pressure below 90 mmHg or mean arterial BP less than 25% of the basal

次要结局

未报告次要终点

研究者

发起方
Sohar Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Amir M Shabana

Assistant prof

Sohar Hospital

研究点 (1)

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