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临床试验/NCT06722742
NCT06722742招募中3 期

Frequency of Shivering Among Patient Treaed With IV Tramadol Versus Iv Ketamine in Prevention of Post Spinal Anesthesia Undergoing Cesarean Section: Rendomiced Control Trial

Liaquat National Hospital & Medical College1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年9月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
250
试验地点
1
主要终点
Shivering

研究概览

简要总结

*Ketamine:* Ketamine is a medication that can help reduce shivering by blocking certain nerve signals in the brain. It's like a "nerve blocker" that helps calm down the body's shivering response.

  • *Tramadol:* Tramadol is a pain medication that can also help reduce shivering. It works by affecting the brain's temperature regulation centers, which helps to reduce the shivering response.

详细描述

Post-spinal shivering is when a patient starts shaking or shivering after receiving spinal anesthesia. This can be uncomfortable and even scary for the patient.

Using ketamine and tramadol to reduce post-spinal shivering can have several benefits, including:

  • Reduced discomfort and anxiety for the patient
  • Improved patient satisfaction
  • Reduced need for additional medications or interventions
  • Faster recovery times

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pateint for elective cesarean section
  • Age 18 to 40 years
  • ASA 1 and 2

排除标准

  • ASA 2 and 3
  • Cesarean section requiring general anesthesia
  • Hypersensitivity to Ketamine, Tramadol and Opiods
  • History of cardiovascular disease

研究组 & 干预措施

Group T

Active Comparator

Group T receive Inj: Tramadol

干预措施: Tramadol (Drug)

Group K

Active Comparator

Group K receive Inj: ketamine

干预措施: Ketamine only (Drug)

结局指标

主要结局

Shivering

时间窗: 20 minutes to 12 hours

Scale validated by crossley and mahajan Grade 0: No shivering Grade 1: Piloerection, peripheral vasoconstriction, peripheral cyanosis, or mild fasciculation of the face or neck, but no visible muscle activity Grade 2: Visible muscle activity in one muscle group Grade 3: Visible muscle activity in more than one muscle group Grade 4: Gross muscle activity involving the entire body

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

Nazish Kanwal

Principal Investigator

Liaquat National Hospital & Medical College

研究点 (1)

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