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临床试验/CTRI/2019/01/016944
CTRI/2019/01/016944尚未招募不适用

Incidence of pruritus after administration of intrathecal Fentanyl in orthopaedic surgeries.

MGM Medical college And Hospital1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2019年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
85
试验地点
1
主要终点
Incidence of pruritus

研究概览

简要总结

Patients to be posted for lower limb orthopaedic surgeries under spinal anaesthesia will be included in the study. After informed consent, spinal anaesthesia will be given in L3-4 intervertebral space in sitting position. Hyperbaric Bupivacaine (10 - 15 mg) and Fentanyl (25 mcg) will be injected intrathecally.

After administration of intrathecal fentanyl, occurence and severity of pruritus will be assessed. Severity of pruritus will be scored from 0-2 (where 0 = no pruritus, 1 = mild to moderate pruritus requiring no treatment, 2 = severe pruritus requiring treatment) at 30 min, 1 hour, 2 hour, 4 hour and 6 hour. Site of pruritus will also be documented.

In case of severe pruritus, Inj. Nalbuphine 2 - 3 mg will be given IV. If no response then Inj. Naloxone 0.1 - 0.2 mg will be given.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients receiving spinal anaesthesia using local anaesthetics & Fentanyl for lower limb orthopaedic surgeries.

排除标准

  • Patients having skin disease with pruritus 2)Patients having systemic disease with pruritus 3)Patient receiving antihistaminics or steroids 4)Patients with Opioid dependency 5)Patients with Psychiatric disorders.

结局指标

主要结局

Incidence of pruritus

时间窗: Intraoperative and postoperative for 6 hours

次要结局

  • severity of pruritus(at 30 min., 1 hour, 2 hour, 4 hour and 6 hour after administration of intrathecal fentanyl)

研究者

申办方类型
Private medical college

研究点 (1)

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