A comparative evaluation of nebulized dexmedetomidine-ketamine versus nebulized dexmedetomidine-midazolam as premedication in pediatric patients undergoing surgery under general anesthesia:A prospective, randomized double blind study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare parenteral separation and mask acceptance with ketamine and midazolam when combined with dexmedetomididne repectively, in nebulized form.
研究概览
简要总结
Preoperative period is a stressful event in majority of pediatric individual undergoing surgical procedure. Smooth induction of anesthesia in pediatric patients requires adequate premedication. Nebulization drug delivery is relatively easy and atraumatic mode. It reduces anxiety pain; decreases physical discomfort ; minimizes psychological trauma with a potential for anesthesia. Dexmedetomidine is potent drug and causes dose related sedation by its effect. It has been used in pediatric patients as premedication, as there is no respiratory depression or confusional state. Midazolam and ketamine has also been used as premedication. Ketamine has been used to induce sedation and analgesia in various settings. Midazolam has rapid onset of action and good sedation. All three drugs have their own side effects, respectively. The individual disadvantage of each drug can be counterbalanced when used in combination. The purpose of this study is to compare the efficacy of two nebulized sedation combination regimes of dexmedetomidine-ketamine and dexmedetomidine-midazolam in pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA Class I & II.
- •2.Weight between 8-40 kgs.
- •3.Undergoing elective surgical procedure.
排除标准
- •1.Known allergy to the study drug.
- •2.Organ dysfunction.
- •3.Cardiac dysrrhythmia and/or Congenital heart disease.
- •4.Psychotropic medication use and mental retardation.
- •5.History of chronic illness,prematurity,or developmental delay.
- •6.Medical conditions contraindicating the use of drugs like-active GERD, uncontrolled vomiting, recent history of apnea,and active respiratory issues.
- •7.Nasal deformities-spur and deviated nasal septum.
- •8.Uncooperative patients.
- •10.Gut surgery.
结局指标
主要结局
To compare parenteral separation and mask acceptance with ketamine and midazolam when combined with dexmedetomididne repectively, in nebulized form.
时间窗: 4 hours
次要结局
- 1.The level of sedation when child is first seen in the operating room.(2.Acceptance of IV cannulation.)