Intravenous Dexmedetomidine Vs. Lidocaine for Laryngeal Mask Insertion Conditions In Pediatric Patients Undergoing Elective Surgeries, A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- First-attempt insertion success rate
研究概览
简要总结
Laryngeal Mask Airways Are Supraglottic Devices Used to Maintain Airway Patency During Anesthesia and in Difficult Airways. LMA may help in reducing postoperative pulmonary complications. IV Dexmedetomidine Improves LMA Insertion Success and Decreases trials number, While IV Lidocaine Decreases Postoperative Cough. This is a randomized interventional trial comparing both drugs. IV DEX will be compared vs IV lidocaine regarding the feasibility of insertion, number of trials, incidence of cough, postoperative pulmonary complications and hemodynamic profile.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parental/guardian consent.
- •Age 2-12 years
- •ASA physical status I-II.
- •Elective surgery requiring LMA (duration <2 hours).
排除标准
- •Known airway anomalies (e.g., tonsillar hypertrophy, cleft palate).
- •Cardiovascular disease (bradycardia, arrhythmias).
- •Allergy to study drugs.
- •BMI >95th percentile.
研究组 & 干预措施
Group (D) DEX
Dose: 0.2 mcg/kg IV in 10 mL saline, infused over 10 min pre-induction.
干预措施: Dexamedomedine (Drug)
Group (L) Lidocaine
Dose: 1.5 mg/kg IV (max 100 mg) in 10 ml saline over 1 min before induction.
干预措施: Lidocaine (drug) (Drug)
结局指标
主要结局
First-attempt insertion success rate
时间窗: After induction of anesthesia
The success of the first trial of classic LMA insertion will be assessed. Binary: yes or no.
次要结局
- Ease of insertion (4-point scale)(After Induction of anesthesia)
- Heart rate(Every 15 minutes till recovery)
- MAP(Every 15 minutes)
- Recovery Time(After cessation of anesthesia administration)
- Postoperative Agitation(In PACU)
- Postoperative Complications(0,1,2,6 hours postoperative.)
- PONV(24 hours postoperative)
- Postoperative sore throat (0-3 scale).(24 hours postoperative)
研究者
Abdelrahman Hamdy Mohammed
Lecturer of Anesthesia & ICU, Faculty of Medicine, Assiut University
Assiut University