跳至主要内容
临床试验/CTRI/2025/01/079087
CTRI/2025/01/079087尚未招募不适用

Comparative evaluation of Dexmedetomine and Clonidine as an adjuvant to Ropivacaine (H) in subarachnoid block for infraumbilical surgeries

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Onset of sensory and motor blockade

研究概览

简要总结

Due to its quick onset and efficiency, the subarachnoid block is a popular anesthetic option for infra umbilical procedures. Research on administering adjuvants with local anesthetics in subarachnoid blocks is ongoing, and two drugs that show promise for enhancing postoperative analgesia and sensory and motor blockade are clonidine and dexmedetomidine

Objective

To compare the safety and effectiveness of Dexmedetomidine and Clonidine as adjuvants to Ropivacaine in subarachnoid blocks for infra-umbilical procedures.

Methods

A randomization process will be used to divide sixty adult patients scheduled for elective infra umbilical procedures into two groups: Group C will receive Clonidine with Ropivacaine. In contrast, Group D will receive Dexmedetomidine with Ropivacaine. Intensive intraoperative and postoperative monitoring, vital sign assessments, and preoperative evaluations will all be carried out. A comparison of the two groups will be conducted, and parameters including the duration of postoperative analgesia, hemodynamic stability, sensory and motor blockade period, and adverse events will be evaluated.

Conclusion

As adjuvants in subarachnoid blocks for infra umbilical procedures, the research will show clonidine and dexmedetomidine efficacy and safety profiles. The selection of adjuvants may be contingent upon particular therapeutic needs and patient attributes. The study findings will focus on improving patient outcomes, comfort, and safety while improving anesthesia techniques for non traumatic surgery.

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.) Adult patients between the ages of 18 and 60 years, 2.) Patients scheduled for elective infra-umbilical surgeries, 3.) American Society of Anesthesiologists (ASA) physical status I or II, 4.) Surgery duration ranging between one and three hours.

排除标准

  • 1.) Allergic reactions to any of the research drugs.
  • 2.) Recognized contraindications to spinal anesthesia, 3.) Significant cardiovascular disease or a history of cardiac arrhythmias, 4.) Pregnant females, 5.) Coagulopathy or hemorrhagic conditions, 6.) Surgery duration less than one hour or more than three hours 7.) Incapacity to give informed consent.

结局指标

主要结局

Onset of sensory and motor blockade

时间窗: 24 hours

The level of sedation

时间窗: 24 hours

Hemodynamic parameters

时间窗: 24 hours

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Kaustuv Das

Datta Meghe Institute Of Higher Education And Research

研究点 (1)

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