Effect of Administration of Intratracheal Dexmedetomidine on Recovery From General Anesthesia in Pediatrics Undergoing Lower Abdominal Surgery: a Randomized Double-blinded Controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the coughing severity
研究概览
简要总结
The incidence of intratracheal tube-induced laryngeal irritation, including coughing, bucking, and cardiovascular stimulation, on emergence from general anesthesia has been reported to occur in 38% and 96% of cases. This may cause agitation and unstable hemodynamics during anesthesia recovery, and can lead to complications, such as laryngeal edema, sore throat, increased intra-abdominal pressure, and anastomotic bleeding. Accordingly, many anesthesiologists have been seeking methods through which such laryngeal irritation can be attenuated, thus allowing for a smoother extubation. Furthermore, it has contributed to the aggravation of cough reflexes.
详细描述
Several strategies have been reported to facilitate smoother extubation, such as intravenous lidocaine, remifentanil, and dexmedetomidine. Dexmedetomidine is a potent, alpha-2-selective adrenoceptor agonist that causes sympatholytic, sedation and analgesia without respiratory compromise. The sedative properties of dexmedetomidine are largely due to effects on the locus ceruleus, producing a level of consciousness mimicking natural sleep Delivering dexmedetomidine intravenously to attenuate airway and circulatory reflexes during extubation has been extensively evaluated in clinical studies. Recent studies have also indicated that the intranasal application of dexmedetomidine is significantly useful and effective in the achievement of improved sedation and analgesia) and offers a safety profile similar to traditional sedatives ( ketamine and midazolam). Additionally, intratracheal local anesthetic instillation has been reported to be effective in preventing laryngeal reflexes. However, both the efficacy and safety profile of intratracheal dexmedetomidine applications are largely unknown and the technique has not been specifically investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status classification I-II.
- •Scheduled for lower abdominal surgeries e.g. congenital hernia repair and correction of penile hypospadias under general anesthesia (GA).
排除标准
- •Younger than 1 year and older than 6 years of age,
- •ASA score of III to IV.
- •Parental refusal
- •Allergy or contraindication to studied medication or anesthetic agents
- •Patients with respiratory disease, heart disorders which might represent risk factors of potential complications of Dexmedetomidine such as bradycardia, hepatic or renal insufficiency.
研究组 & 干预措施
CON group
placebo
干预措施: Saline Solution (Drug)
DT group
Intratracheal dexmedetomidine
干预措施: Intratracheal dexmedetomidine (Drug)
结局指标
主要结局
the coughing severity
时间窗: intraoperative (during the recovery period from the time of awareness to 5 min after extubation)
judged by the 4-point scale. 0 = no cough, 1= minimal (single) cough, 2 = moderate (≤5 ) cough and 3= severe (\>5 ) cough. Grades 2 and 3 were bad.
次要结局
- the Pediatric Objective Pain Scale(24 hours postoperative)
研究者
Ghada Mohammed AboelFadl
Principal investigator
Assiut University