跳至主要内容
临床试验/CTRI/2025/05/086263
CTRI/2025/05/086263尚未招募4 期

Optimal dose of Dexmedetomidine added to 0.2 percent Ropivacaine in Caudal Block for post operative analgesia in paediatric patients: a randomised prospective controlled study

Rajendra Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年5月13日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
75
试验地点
1
主要终点
To record the time of requirement of first rescue

研究概览

简要总结

Pediatric patients require specific attention when it comes to postoperative analgesia and  caudal block as a central nerve block technique, is one of the common methods performed to  manage perioperative pain in pediatric lower abdominal and perineal surgeries. Local  anesthetics have usually been the main drug in such cases, and if administered alone in the  caudal blockade, they do not usually provide prolonged analgesia. Ropivacaine is one of the most common drugs in this group. The addition of dexmedetomidine to local anesthetics or its administration as  an adjunct for pain management in a variety of techniques enhances their effects. This study will be carried out to compare the efficacy of ropivacaine with different doses of  dexmedetomidine in caudal block for pediatric lower abdominal and perineal surgeries.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
2.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Assessed patients of ASA physical status I and II.
  • Normal biochemical and hematological parameters.
  • Age group between 2-6 years.
  • Lower abdominal and perineal surgeries, lasting one to three hours under general anaesthesia f.
  • Informed written conset from legal guardian.

排除标准

  • Parent/legal guardian not willing b.
  • Sacral abnormalities c.
  • Patients with coagulopathies d.
  • History of allergy to study drug.

结局指标

主要结局

To record the time of requirement of first rescue

时间窗: Visual Analogue Scale Score | Just after extubation | 1hours post surgery | 2hours post surgery | 6hours post surgery | 12hours post surgery | 24hours post surgery

analgesic

时间窗: Visual Analogue Scale Score | Just after extubation | 1hours post surgery | 2hours post surgery | 6hours post surgery | 12hours post surgery | 24hours post surgery

次要结局

  • a) To record the hemodynamic parameters systolic blood pressure, diastolic blood pressure, heart rate and MAP(b) To record incidence of adverse effects i.e. hypotension, bradycardia and sedation)

研究者

申办方类型
Government medical college

研究点 (1)

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