A randomized controlled study to evaluate effectiveness of propofol administered at the end of the surgery for prevention of emergence agitation in children undergoing adenotonsillectomy in department of anaesthesia, SMS Medical College, Jaipur.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To determine and compare the incidence (WATCHA scale) and severity (PAED scale) of emergence agitation in both study and control group.
研究概览
简要总结
Emergence agitation is characterised by a
state of mental confusion, agitation, and disinhibition marked by some degree of hyperexcitability manifesting as restlessness, agitation, thrashing, crying, moaning, disorientation and incoherence after recovering from anaesthesia. Multiple factors have been identified that affect incidence and severity of emergence agitation like age of the patient, type of surgery ,pain, higher preoperative anxiety level, feeling of suffocation and use of sevoflurane . Higher incidence is found in paediatric age group and patients undergoing ear, nose, throat (ENT) and ophthalmic Post-operative emergence agitation occurring in paediatric patient must be taken a special care because they may deteriorate very rapidly and may put the life of the patient into danger.So it is better to prevent occurrence of emergence agitation rather than cure. With this background we have planned this study to evaluate the effectiveness of prophylactic dose of propofol for prevention of emergence agitation in paediatric patients undergoing d
adenotonsillectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •All elective ASA I & II paediatric patients of either sex, age between 3-10 years undergoing adenotonsillectomy under general anaesthesia.
- •Patient’s parents willing to give consent.
排除标准
- •Patients part of any other study.
- •Non co-operative patient.
- •Patient with known allergy to propofol.
- •Patient with known psychiatric disorder.
- •Patients having upper respiratory tract infection.
- •Patient requiring intra operative propofol for any indication.
结局指标
主要结局
To determine and compare the incidence (WATCHA scale) and severity (PAED scale) of emergence agitation in both study and control group.
时间窗: 5 minute, 10 minute, 15 minute
次要结局
- 1. To determine and compare the emergence time between two groups.(2. To determine side effects and complication if any.)
研究者
Dr Mamta Sharma
Sawai Man Singh Medical College