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临床试验/CTRI/2024/07/071692
CTRI/2024/07/071692尚未招募不适用

Effect of supplemental caudal analgesia on intraoperative blood glucose level in pediatric patients undergoing infraumbilical surgery

MS Ramaiah Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To compare the blood glucose levels in children undergoing infraumbilical surgeries under general anaesthesia with and without caudal analgesia

研究概览

简要总结

Surgery induces a neuroendocrine stress response resulting in changes of metabolic state and immune function. The stress response stimulates release of catecholamines and cortisol which have an anti-insulin action predisposing to increase plasma glucose levels. Hyperglycaemia increases the risk of hypoxic-ischemic brain or spinal cord damage, induces diuresis and subsequently dehydration and electrolyte imbalance.

Pain is a major cause of stress in children and should be managed optimally in the perioperative period to reduce the adverse effects of stress response. Systemic analgesics and/or local anaesthetics in regional anaesthesia are administered for perioperative pain management which also blunts the surgical stress response. Caudal block is the most commonly employed technique of regional anaesthesia in children undergoing infraumbilical surgery for pain relief which may attenuate stress response and optimise blood glucose levels by inhibition of endogenous glucose production.

Currently there is paucity of studies that have observed the effect of caudal analgesia on blood glucose level in children. Hence in our study we aim to compare the blood glucose level in children under general anaesthesia with and without caudal analgesia.

We hypothesize that supplemental caudal analgesia with general anaesthesia may influence the intraoperative blood glucose levels.

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
1.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Patients aged between 1 – 6 years American Society of Anesthesiologists physical status 1 and 2 Scheduled for elective infraumbilical surgeries.

排除标准

  • Baseline blood sugar less than 70mg/dl Patients allergic to local anesthetics History of endocrine disorders Patients on steroid supplementation Any contraindication for caudal block Malformation of spine Infection around puncture site Coagulation dysfunction.

结局指标

主要结局

To compare the blood glucose levels in children undergoing infraumbilical surgeries under general anaesthesia with and without caudal analgesia

时间窗: Baseline | 30 minutes after start of surgery | 60 minutes after start of surgery | 30 minutes after end of surgery

次要结局

  • To compare intraoperative hemodynamic parameters between two groups

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Shivshankar R Tengli

MS Ramaiah Medical College

研究点 (1)

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