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临床试验/CTRI/2025/07/090420
CTRI/2025/07/090420尚未招募4 期

Efficacy of sequential intrathecal injection of Hyperbaric Bupivacaine-Fentanyl followed by Isobaric Bupivacaine compared with Hyperbaric Bupivacaine-Fentanyl in orthopaedic lower limb surgeries in geriatric patients: A prospective randomised double blind clinical study

Government Medical College, Baroda.1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年7月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
To observe haemodynamic stability (blood pressure, pulse rate) and number of

研究概览

简要总结

The aim of this study is to compare the efficacy of sequential injection of hyperbaric bupivacaine with fentanyl followed by isobaric bupivacaine and hyperbaric bupivacaine with fentanyl intrathecally and to study the haemodynamic effects and recovery in lower limb surgeries in geriatric patients. 84 patients for lower limb orthopaedic surgeries will be randomly allocated in two different groups. In each group, there will be 42 patients who are posted for elective or emergency lower limb orthopaedic surgeries.In one group HIB group, Inj. Hyperbaric Bupivacaine 1 ml with Inj. Fentanyl 0.5ml followed by Inj. Isobaric Bupivacaine 1ml will be given intrathecally without barbotage. In second group, HB group, Inj. Hyperbaric Bupivacaine 2 ml with Inj. Fentanyl 0.5ml will be given intrathecally. As the primary outcome, haemodynamic stability (blood pressure, pulse rate) and number of doses of Inj. Ephedrine (5mg) i.v. required will be observed. As the secondary outcome, comparison of sensory and motor blockade characteristics will be assessed. The proposed advantage of this study is that the sequential intrathecal administration of Inj. Hyperbaric Bupivacaine+ Inj. Fentanyl followed by Inj. Isobaric Bupivacaine may be helpful in reduction of intraoperative hypotension and subsequent lower vasopressor requirements in geriatric patients while achieving satisfactory block characteristics (e.g., onset, intensity, and duration) when compared to Inj. Hyperbaric Bupivacaine+ Inj. Fentanyl alone.

研究设计

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

入排标准

年龄范围
65.00 Year(s) 至 99.00 Year(s)(—)

入选标准

  • Age Group – 65 to 99 year 2) Either Gender.
  • ASA – II/III 4) Orthopaedic lower limb surgeries 5) Duration of surgery: 2.5 to 3 hours 6) Patients providing written informed consent.

排除标准

  • Patient refusal.
  • Patients with Local skin infection, Vertebral column abnormalities, bleeding disorders, cardiopulmonary disease, neuropathies).
  • Patients with allergy to study drugs.
  • BMI more than 30kg/m2.

结局指标

主要结局

To observe haemodynamic stability (blood pressure, pulse rate) and number of

时间窗: Till 8 hours

doses of Inj. Ephedrine (5mg) i.v. required

时间窗: Till 8 hours

次要结局

  • To assess Sensory and Motor blockade characteristics– like(Onset of sensory block at L1 dermatomal level(mins))

研究者

发起方
Government Medical College, Baroda.
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Shreenidhi Patel

Government Medical College, Baroda

研究点 (1)

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