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临床试验/CTRI/2026/01/100565
CTRI/2026/01/100565尚未招募Unknown

Comparison of effect of different drug volumes of local anaesthetic for caudal analgesia on optic nerve sheath diameter in paediatric patients undergoing elective infra umbilical surgery.

VMMC and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月18日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare between 0.5ml/kg and 1.0ml/kg drug volumes of local anaesthetics for caudal analgesia on optic nerve sheath diameter in paediatric patients undergoing elective infra umbilical surgery.

研究概览

简要总结

Caudal block has become one of the most popular regional anaesthesia techniques for paediatric surgeries. It is administering of a local anaesthetic into the epidural space via the sacral hiatus to achieve anaesthesia of sacral and coccygeal nerve root. Depending on the site of surgery, different volumes are chosen for caudal block procedure.

 The optic nerve is a white matter tract of the brain that transmits cerebral spinal fluid and fluctuates in size based on changes in intracranial pressure. As optic nerve is capsulated by the distensible subarachnoid space, any change of intracranial pressure would theoretically reflect on this measurement. There is increasing evidence that optic nerve sheath diameter via a well correlated parameter with intracranial pressure and has high diagnostic precision for detecting altered intracranial pressure in children. Trans-orbital sonography is one of the non-invasive method to measure optic nerve sheath diameter.

 In this study, we will compare 0.5ml/kg and 1.0ml/kg drug volume of local anaesthetic for caudal analgesia on optic nerve sheath diameter in paediatric patients from 6 months to 60 months belonging to ASA I-II undergoing elective infra-umbilical.

 The methodology and procedure of the study will be explained to the patients’ parents and informed written consent will be taken from parents. A computer generated random number table will be used allocate patients in 2 groups (Group low volume and Group high volume).

 Patients will be taken to the OT, monitors will be attached and baseline vitals noted. After preoxygenation with 100% oxygen, induction with fentanyl, propofol and muscle relaxant and intubating with LMA will be done.

 Based on allocated drug volume 0.5ml/kg or 1.0ml/kg drug volume will be taken for caudal block. A baseline optic nerve sheath diameter will be measured before giving caudal block and measured again after 1 minute, 10 minutes and 30 minutes after giving caudal block. BP, HR, end tidal carbon dioxide, end tidal sevoflurane, oxygen saturation will also be noted simultaneously.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
6.00 Month(s) 至 60.00 Month(s)(—)
性别
All

入选标准

  • All patients in the age group of 6-60 months of either gender belonging to ASA I-II undergoing elective infra umbilical surgery under general anaesthesia.

排除标准

  • 1.Spinal anomalies or infection at the sacral region.
  • 2.Coagulopathy.
  • 3.Ophthalmic disease.
  • 4.Known case of increased ICP: Hydrocephalus, Space occupying lesions, infection etc.
  • 5.Known allergic history to local anaesthetics.

结局指标

主要结局

To compare between 0.5ml/kg and 1.0ml/kg drug volumes of local anaesthetics for caudal analgesia on optic nerve sheath diameter in paediatric patients undergoing elective infra umbilical surgery.

时间窗: Measuring optic nerve sheath diameter before caudal block, and 1 minute, 10 minutes and 30 minutes after caudal block.

次要结局

  • To study the changes in vital parameters using 0.5ml/kg and 1.0ml/kg drug volumes of local anaesthetics for caudal analgesia.(Measuring the changes in vital parameters before giving caudal analgesia, and 1 minute, 10 minutes and 30 minutes after caudal analgesia.)

研究者

发起方
VMMC and Safdarjung Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Swrang Daimari

VMMC and Safdarjung Hospital

研究点 (1)

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