Comparison of two different doses of Dexmedetomidine versus Nalbuphine in attenuation of Sevoflurane associated emergence agitation in paediatric patients undergoing hypospadias repair- a hospital based randomised controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- To compare effects of 0.3 mcg/kg of Dexmedetomidine IV , 0.5 mcg/kg of
研究概览
简要总结
it is a novel study comparing the effects of two different doses of dexmedetomidine versus one dose of nalbuphine on the emergence agitation that occurs with the use of inhalational agent such as sevoflurane in paediatric patients undergoing hypospadias repair under general anaesthesia with laryngeal mask airway and caudal epidural anaesthesia. it shall provide valuable insight on effects of both drugs on the said condition and their optimal dosages in reducing the incidence of sevoflurane associated emergence agitation in paediatric patients posted for hypospadias repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- Male
入选标准
- •ASA physical status I and II.
- •Age between 2 to 10 years.
- •Patients undergoing lower abdominal surgeries
- •Operation time less than or equal to 1 hour.
排除标准
- •Risk of aspiration
- •Known difficult airway
- •Patients with Upper and Lower respiratory tract infections
- •Congenital malformations involving respiratory tract
- •History of epilepsy
- •Patients with cardiac, renal or liver diseases
- •Patients with allergy to the study drug
- •Cervical spine disease
- •Patients with bleeding and coagulation disorders
- •Patients receiving digoxin
- •Preoperatively agitated child.
结局指标
主要结局
To compare effects of 0.3 mcg/kg of Dexmedetomidine IV , 0.5 mcg/kg of
时间窗: BASELINE VALUE | 0 MIN IN PACU | 5 MIN | 10 MIN | 20 MIN | 30 MIN | 40 MIN
Dexmedetomidine IV versus 0.1 mg/kg of Nalbuphine IV in attenuation of emergence
时间窗: BASELINE VALUE | 0 MIN IN PACU | 5 MIN | 10 MIN | 20 MIN | 30 MIN | 40 MIN
agitation resulting from the use of Sevoflurane, in paediatric patients undergoing
时间窗: BASELINE VALUE | 0 MIN IN PACU | 5 MIN | 10 MIN | 20 MIN | 30 MIN | 40 MIN
Hypospadias repair.
时间窗: BASELINE VALUE | 0 MIN IN PACU | 5 MIN | 10 MIN | 20 MIN | 30 MIN | 40 MIN
次要结局
- To assess the Ramsay sedation score and Pain score of 0.3 mcg/kg Dexmedetomidine(IV, 0.5mcg/kg Dexmedetomidine IV and 0.1 mg/kg Nalbuphine IV and their post)
研究者
Dr Tejasvini Kalathuru
Jawaharlal Nehru Medical College, Belagavi, Karnataka, India-590010