Transbucal Dexmedetomidine for the Prevention of Emergence Agitation After Sevoflurane Anaesthesia in Pre-school Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The agitation score up to 1hour postoperative.
研究概览
简要总结
The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in preschool children undergoing tonsillectomy operations in the prevention sevoflurane agitation.
详细描述
Agitation during the emergence from general anesthesia is a great post-operative problem that often injures the patients themselves and requires the medical staff to restrain and calm them. The predisposing factors for emergence agitation include anesthesia, operation, and patient. Sevoflurane anesthesia results in higher incidence of emergence agitation than halothane, because of the rapid emergence, and its effects on central nervous system inducing convulsion and post-operative behavioral changes. The otorhinolaryngologic and ophthalmologic surgeries, post-operative pain, young age, pre-operative anxiety, no past surgical history, and adjustment disorder of patients are risk factors.
Dexmedetomidine (DEX), a selective α (2)-adrenoreceptor agonist. Intravenous DEX used after induction of anesthesia reduced sevoflurane-associated EA and postoperative pain in pediatric ambulatory surgery.
The investigators designed this study to prove the efficacy of oral dexmedetomidine a selective α (2)-adrenoreceptor agonist, on emergence agitation (EA), recovery profiles, and parents' satisfaction after sevoflurane anesthesia in tonsillectomy.
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
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-II patients
- •aged 2-6 years
- •patient scheduled for elective tonsillectomy due to recurrent
- •chronic tonsillitis
排除标准
- •patients with known hypersensitivity to medication drugs
- •coagulation disorders
- •thrombocytopenia
- •significant cardiac
- •pulmonary
- •hepatic disease
研究组 & 干预措施
DEX I
active comparator receive 0.5µg/kg dexmedetomidine orally half an hour before operation
干预措施: Dexmedetomidine (Drug)
Saline Control
2ml oral 0.9%saline half an hour before operation
干预措施: saline (Drug)
DEX II
active comparator receive,1µg/kg dexmedetomidine orally half an hour before operation
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
The agitation score up to 1hour postoperative.
时间窗: first postoperative hour
Agitation intensity will be assessed postoperatively by using agitation score 0= child is asleep. awake/calm =1. irritable/ consolable cry =2. inconsolable cry =3.the child is agitating and thrashing and restlessness Emergence delirium ≥ 3 agitation score will be performed in the following time points; at 5 min postoperative,10 min, 15, 30, 45, 60 min.
次要结局
- Pain score assessed using the objective pain scale.(up to 1hour postoperative hour)
研究者
Hala Saad Abdel-Ghaffar
MD
Assiut University