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临床试验/CTRI/2024/05/067761
CTRI/2024/05/067761尚未招募2/3 期

comparison of fractional versus conventional spinal anesthesia in geriatric patients posted for orthopedic surgery : A Prospective Randomised, double blinded study

S Nijalingappa medical college and HSK hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月10日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To measure the incidence of hypotension among the conventional and fractional spinal anaesthesia group

研究概览

简要总结

Spinal Anaesthesia(SA) frequently performed for lower limb orthopedic surgeries has rapid onset but at the same time, it precipitates hypotension. : Incidence of hypotension during spinal anesthesia for lower limb surgeries in elderly is as high as 92-94% if no preventive measures are taken The rapid onset of spinal anaesthesia can lead to complications such as hypotension, which can be dangerous to the patient, Therefore, recently a fractionated dose injection technique has been developed known as Fractionated Spinal Anesthesia (FSA) in which a local anesthetic agent is given in fractions with a time gap of 60sec-90 sec. This helps in reducing the incidence of hypotension by providing dense blockage with hemodynamic stability and prolonged duration of effective analgesia.Spinal anaesthesia with fractionated method could lead to lower hypotension and bradycardia, longer sensory blockage duration, a more favourable anaesthesia level with lesser complications , in comparision with the bolus method. So, we decided to compare bolus dose conventional spinal versus fractionated dose of bupivacaine in spinal anesthesia for lower limb surgeries in elderly with regard to its effects on incidence of hypotension as our primary objective and Hemodynamic parameters(BP&HR) , block characteristics like Onsent of Sensory and Motor blockade,Duration of sensory and motor blockade Requirments of Vasopressors Time for 1st rescue analgesia Complications in both the groups as well as duration of post-operative analgesia as our secondary objectives.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • A total of patients aged 60yrs old who were candidates for lower limb fracture surgery with ASA I , II & III will be included
  • Patients willing for being a part of the study with written informed consent.
  • (Annexure 1A, 1B, 1C).

排除标准

  • Patients who are not willing to give written informed consent.
  • Patients below 60 years of age.
  • Patients with ASA greater than III
  • The patients with absolute contraindications of spinal anesthesia, such as patient’s refusal , localised infection at the injection site, allergy to anesthetic drugs, patient’s inability to maintain position during the procedure, increased ICP
  • Relative spinal contraindications such as myelopathy or peripheral neuropathy, spinal stenosis, history of spinal surgery, multiple sclerosis, spina bifida, aortic stenosis, hypovolemia, hereditary coagulopathies,.

结局指标

主要结局

To measure the incidence of hypotension among the conventional and fractional spinal anaesthesia group

时间窗: 3hrs

次要结局

  • 1.Haemodynamic parameters(2.onset of sensory & motor blockade)

研究者

发起方
S Nijalingappa medical college and HSK hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DR Archana Endigeri

SNMC and HSK hospital Bagalkote

研究点 (1)

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