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临床试验/NCT06382220
NCT06382220已完成1 期

Low Dose Bupivacaine Versus Prilocaine Regarding Hemodynamic Stability and Safety in Geriatrics: A Randomized, Double-Blind Comparative Study

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
100
试验地点
1
主要终点
The rate of occurrence of hypotension

研究概览

简要总结

Orthopedic interventions under spinal anesthesia is considered a common practice in elderly patients undergo surgery, and may be associated with lower risks of death, delirium,and major medical complications .

Spinal anesthesia can cause disastrous hemodynamical changes in the form of hypotension and bradycardia in elderly patients due to limited physiological reserve and presence of systemic illness . The degree of hypotension is proportional to the extent of sympathetic blockade. thus unilateral Spinal anesthesia described by Tanasichuk et AL. was used aiming to minimize these hymodynamical changes compared to bilateral block by restricting the extent of sympathetic blockade.

Bupivacaine has been used in spinal anaesthesia in orthodecic surgeries . It provides a short motor block onset time with a long motor block duration . If bupivacaine is used, the main disadvantage is the significant inter-individual variability with clinically significant differences in onset time, dermatomal spread and motor block duration . Prilocaine is a local anaesthetic agent that belongs to the same family as bupivacaine. In the last decade and with the development of day surgery, prilocaine 2% has become more commonly used for orthopaedic surgical procedures . Prilocaine induces a shorter motor block with less urinary retention, which better facilitates enhanced recovery after surgery . Usually, doses administered in spinal anaesthesia vary from 20 to 80 mg . Given the intermediate motor block duration,

The aim of this study

To compare between Unilateral low dose spinal anesthesia using bupivacaine versus prilocaine regarding hemodynamical stability and safety in below knee orthopedic surgeries in elderly people.

详细描述

This study will be performed in the in the FAYOUM University hospital after the local Institutional Ethics Committee and local institutional review board approval. The study design will be double-blind randomized controlled study . A detailed informed consent will be signed by the eligible patients before recruitment and randomization.

Population of Study

  • Group 1 : Group (A) Bupivacaine group n = 50 patients who received 7.5 mg (low dose) hyperbaric bupivacaine 0.5% (Marcaine®, AstraZeneca, Sweden) in 2 mL volume (1.5 mL hyperbaric bupivacaine 0.5% diluted with 0.5 mL sterile distilled water) intrathecal at level lumbar L3-L4 or L4-L5 in lateral decubitus position keeping the operated side dependent and remained in this position for 10 min before turning supine.
  • Group 2 : Group (B) Prilocaine group n = 50 patients received 40 mg (low dose) intrathecal hyperbaric prilocaine 2% (Takipril, Sunny Medical group, Egypt under liscense from Sintetica, Switzerland)in 2 mL volume as described in group A. The injection will be in the midline over 30 s by 25 gauge (G) Quincke needle under strict aseptic condition.

Inclusion Criteria :

100 elderly patients (60 years old or above), of either gender, with American Society of Anesthesiologists (ASA) physical status I, II, and III who were scheduled for elective knee and below knee orthopedic surgeries expected to the last for 40-60 min under spinal anesthesia.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elderly patients (60 years old or above)
  • either gender
  • American Society of Anesthesiologists (ASA) physical status I, II, and III who were scheduled for elective knee and below knee orthopedic surgeries expected to the last for 40-60 min under spinal anesthesia.

排除标准

  • Patients height < 1.55 or > 1.75 m,
  • with other neurological diseases, spine abnormalities,
  • absolute, and relative contraindications to spinal anesthesia as patients suffering from intracranial hypertension, major bleeding disorder, patients on anticoagulant, local infection, dementia, and allergic reaction to local anesthetics.

研究组 & 干预措施

Group (A) Bupivacaine group

Active Comparator

who received 7.5 mg (low dose) hyperbaric bupivacaine 0.5%

干预措施: Bupivacain (Drug)

Group (B) Prilocaine group

Active Comparator

patients received 40 mg (low dose) intrathecal hyperbaric prilocaine

干预措施: Bupivacain (Drug)

结局指标

主要结局

The rate of occurrence of hypotension

时间窗: intraoperative

mean arterial blood pressure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ahmed Hamed

professor

Fayoum University Hospital

研究点 (1)

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