Effect of Caudal additive Clonidine to Levobupivacaine in Reducing Incidence of Emergence Agitation in Children Undergoing Infra-Umbilical Surgeries with Sevoflurane Anaesthesia – a prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of emergence agitation
研究概览
简要总结
This study aims to compare the effects of caudal additives clonidine and fentanyl to levobupivacaine in reducing emergence agitation in children undergoing infra-umbilical surgeries with sevoflurane anaesthesia. Caudal block is one of the most reliable and safest techniques for paediatric lower abdominal regional anaesthesia and analgesia and has been found to protect against emergence agitation. Conducted at Kasturba Medical College, the prospective observational study will enroll 120 paediatric patients aged 3 to 10 years undergoing general anaesthesia with sevoflurane and caudal block for infraumbilical surgeries, excluding those with neurological or behavioural disorders, difficult airway or contraindications for caudal blocks. The primary objective is to assess the efficacy of these additives in preventing emergence agitation, a short lived, common and distressing phenomenon during post operative recover period following general anaesthesia. Secondary outcomes will assess time to emergence, duration of postoperative pain relief, sedation levels, and any side effects associated with the additives. Ethical approval and informed consent will be obtained prior to participation. A pre-anaesthetic evaluation will be conducted, and standard fasting protocols will be followed. Anaesthesia will be induced with IV propofol, paralysed with atracurium and anaesthesia maintained with nitrous oxide and sevoflurane, along with a caudal blockade using levobupivacaine combined with either clonidine or fentanyl as per the discretion of concerned consultant anaesthesiologist. Vital signs will be continuously monitored during the procedure. Post-surgery, neuromuscular reversal will occur, and patient extubated. Emergence time will be measured. In the Post Anaesthesia Care Unit, children will be evaluated for emergence agitation, pain and sedation using specific scoring systems.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Paediatric patients undergoing infra umbilical surgeries under general anaesthesia without endotracheal intubation 2.Age
- •10 years 3.American Society of Anaesthesiologists (ASA) status I and II.
排除标准
- •1.Guardian refusal to consent.
- •2.Patients with developmental delay, intellectual disability, behavioural disorders, cardiac diseases.
- •3.Contraindication for caudal block (infection at site of block, bleeding diathesis, pre-existing spinal disease, abnormalities of sacrum) 4.Pre-operative agitation (difficult to separate from parents despite midazolam premedication) 5.Potential difficult airway 6.Additional iv analgesic requirement intra operatively after caudal administration.
结局指标
主要结局
Incidence of emergence agitation
时间窗: PAED score at immediate post extubation, 5 min, 10min, 15 min, 30 min, 45 min and 60 min post extubation
次要结局
- 1.Time to emergence(2.Post operative pain relief)
研究者
Dr Shabnam Nazar
Kasturba Medical College and Hospital