Emergence Agitation in Pediatrics After Dexmedetomidine vs. Sevoflurane Anesthesia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Emergence Agitation
研究概览
简要总结
Emergence agitation is commonly encountered after receiving inhalation anesthesia. This distressing phenomenon carries risks that are harmful to patients, caregivers and medical personnel. Using total intravenous Dexmedetomidine, the investigators seek to reduce agitation and provide gentle emergence from anesthesia.
详细描述
Surgery for pediatric cleft lip and palate repair often utilizes high dose opioids and inhaled anaesthesia, thereby causing postoperative complications such as desaturation and/or severe agitation after anesthesia. These complications are detrimental to the child, medical personnel and causes tremendous psychologic stress to parents. This study aims to decrease these complications through Dexmedetomidine, an Alpha-2 receptor agonist with anxiolytic, sympatholytic and analgetic properties. Devoid of respiratory depressant effect, it allows patients to maintain effective ventilation and reduce agitation, postoperatively. Its unique anesthetic property may shed light to provide safe anesthesia and gentle emergence to this young, vulnerable population.
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
- Single (Participant)
盲法说明
Patients are selected randomly using a computer-generated device to become a control arm or a treatment arm
入排标准
- 年龄范围
- 3 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with weight ranging 5 kg - 25 kg
- •Patients with American Society of Anesthesiologist (ASA) Physical Status Classification 1 and 2
排除标准
- •Patients with any acquired congenital syndrome
- •Patients who are actively taking anti-seizure medications and/or has been diagnosed with epilepsy
- •Patients with functional and structural abnormalities of the heart, including arrythmias
- •Patients with liver disease
研究组 & 干预措施
Inhalation Sevoflurane
Participants in this group will receive inhalation anesthesia Sevoflurane at 2-3 Vol% as their sole anesthetic maintenance agent throughout the surgical procedure.
干预措施: Sevoflurane (Drug)
Total Intravenous Dexmedetomidine
Participants in this group will receive Total Intravenous Dexmedetomidine as their sole anesthetic maintenance agent. Intravenous Dexmedetomidine 1.5ug/kg will be administered within 10 minutes and maintenance dose of 1.5ug/kg/hour will be given throughout the surgical procedure.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Emergence Agitation
时间窗: Assessed starting the time of extubation and every 15 minutes interval until the patient is completely awake in the recovery room. The average of all values throughout the observation period was summed and the average scale reported.
Cravero scale uses a numeric scale. 1 = obtunded with no response to stimulation; 2 = asleep, but responsive to movement or stimuli; 3 = awake and responsive, 4 = crying; 5 = thrashing behavior that requires restraint. Minimum values of NOT AGITATED is 1.0 up to maximum of 2.9. Minimum values of AGITATED is 3.10 up to maximum of 5.0. Cravero scale is measured from the moment of extubation and every 15 minutes thereafter until the patient is completely awakened (in the recovery room). The total score is summed, and the average is reported.
Duration of Anesthesia (Minutes)
时间窗: From time of anesthesia induction up to the termination of anesthetic agent, assessed up to two hours.
Measures the time of anesthesia (in minutes) starting from induction of anesthesia to the termination of anesthetic agent
Duration of Surgery (Minutes)
时间窗: From time of surgery up to the termination of anesthetic agent, assessed up to two hours.
Measures the time of surgery after the application of sterile draping up to the end of surgery.
次要结局
- Time to Extubation (Minutes)(Maximum time to extubate was up to 26 minutes.)
- Time to Full Recovery(Maximum time observed was up to 105 minutes.)
研究者
Corry Quando Yahya
Pediatric Anesthesiologist and Lecturer at Pelita Harapan University, Department of Anesthesia and Intensive Care
Pelita Harapan University