Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine to Induce Preoperative Sedation and Attenuate Emergence Agitation in Children Undergoing Cleft Palate Repair Surgeries
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- University of Michigan Sedation Scale (UMSS)
研究概览
简要总结
To compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing cleft palate repair surgeries.
详细描述
Cleft palate is a common congenital anomaly. The American cleft palate-craniofacial Association recommends that primary cleft palate repair should be ideally performed between 12-18 months after birth.
The pre-operative period is quite distressing for children due to parental separation, application of face mask for induction of anaesthesia, fear of needles and unfamiliar faces. Pre-operative Anxiety is associated with adverse outcomes via elevation of stress markers, promoting fluctuations in hemodynamic, and negatively impacting postoperative recovery. There is a growing interest in the use of dexmedetomidine, a highly selective alpha-2 adrenergic agonist, for paediatric premedication. Ketamine may attenuate dexmedetomidine-induced bradycardia and hypotension and accelerate the onset of sedation with no respiratory depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 48 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with American Society of Anesthesiologists (ASA) physical status I & II who will be scheduled for cleft palate repair surgeries
排除标准
- •Parent refusal
- •Allergy to the study drugs
- •Suspected difficult airway
- •Patients with endocrine, renal, hepatic, and cardiac pathology
- •Psychiatric diseases
- •Asthmatic patients.
研究组 & 干预措施
Nebulized dexmedetomidine and ketamine
Pre-operative nebulization of dexmedetomidine and ketamine
干预措施: Nebulization of dexmedetomidine and ketamine (Drug)
Nebulized dexmedetomidine
Pre-operative nebulization of dexmedetomidine
干预措施: Nebulization of dexmedetomidine (Drug)
结局指标
主要结局
University of Michigan Sedation Scale (UMSS)
时间窗: Pre-operative
It ranges from 0 = awake, alert to 4 = unarousable
次要结局
- Parental Separation using the Parenteral Separation Anxiety Scale (PSAS)(Pre-operative)
- Watcha scale for emergence delirium(Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit.)
研究者
FATMA NABIL AHMED MOHAMED
Clinical Supervisor
Assiut University
