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临床试验/NCT07485127
NCT07485127进行中(未招募)1 期

Comparison Between Dexamethasone and Dexmedetomidine as Adjuvant to Bupivacaine in Spinal Anesthesia for Cases With Fracture Pelvis Fixation Comparative Randomized Study

Sohag University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月8日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
• Duration of block.

研究概览

简要总结

The aim of this study is to compare dexamethasone and dexmedetomidine as adjuvant to bupivacaine in fracture pelvis fixation as regard duration of sensory block and postoperative pain management.

详细描述

Place of the study:

Sohag University Hospitals after approval from the institutional ethical committee.

Study Design:

This prospective comparative study will be conducted on patients with fracture pelvis at the Department of Anesthesia, Intensive Care, and Pain Management,in Sohag University Hospitals after approval of the Research Ethical Committee.

Study period:

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
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 20 to 80 years.
  • Both sexes.
  • Patients will be classified as American Society of Anesthesiologists (ASA) class I - II.
  • Patient scheduled for surgical fixation of pelvic fracture.

排除标准

  • Patients with drug addiction, and sepsis.
  • Infection at the injection site.
  • Sensitivity to local anesthetics.
  • Coagulopathy.
  • Kidney failure, liver failure.
  • History of previous paresis in the operation area.

结局指标

主要结局

• Duration of block.

时间窗: onset of a few minutes and duration of 1.5-4 hours

Spinal anesthesia involves injecting a local anesthetic into the CSF. It is preferred when the surgical site is suitable for spinal blockade, especially in patients with severe respiratory disease or difficult tracheal intubation. Bupivacaine is a long-acting local anesthetic used for spinal anesthesia. By blocking sodium channels, it produces rapid, profound sensory and motor blockade with onset within minutes and a duration of 1.5-4 hours. To enhance local anesthetic effects, various adjuvants have been studied to improve onset, duration, and block quality. Dexamethasone as an adjuvant to bupivacaine prolongs block duration, improves onset, intensity, sedation, and reduces postoperative pain. Dexmedetomidine, an alpha-2 agonist, provides sedation, anxiolysis, and analgesia; it shortens onset, prolongs block duration, delays analgesic need, and has minimal side effects.

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

Soha Mohamed

Principal Investigator

Sohag University

研究点 (1)

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