Does Dexmedetomidine Decrease the Incidence of Untoward Airway Events After Deep or Awake Extubation in Patients Undergoing Adenotonsillectomy With or Without Myringotomy and Tube Placement?
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Number of Participants With Respiratory Complications
研究概览
简要总结
The investigators aim to investigate the effect of dexmedetomidine on the perioperative respiratory complications in this patient population undergoing both awake and deep tracheal extubation.
详细描述
We propose a prospective double-blinded randomized controlled trial. 336 pediatric patients presenting to Massachusetts Eye and Ear Infirmary (MEEI) for adenotonsillectomy who are eligible for the study based on inclusion and exclusion criteria will be recruited. A Clinical Pharmacy specialist, will be in charge of preparing the dexmedetomidine and placebo doses and will randomize the patients to four equally numbered groups. The anesthesiologist will receive the assignment for the extubation method in a sealed envelope from the Clinical Pharmacy specialist. Multiple parameters will be recorded in perioperative period to quantify perioperative adverse respiratory events.
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
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 3 to 16 years of age undergoing adenotonsillectomy, with or without myringotomy or myringoplasty
- •ASA 1 & 2
排除标准
- •Known allergy or hypersensitivity reaction to dexmedetomidine
- •Organ dysfunction (renal/hepatic failure or leukemia)
- •Cardiac disease (congenital or acquired)
- •Airway or thoracic malformation
- •Cerebral palsy
- •Hypotonia
- •Need for premedication
- •Current/recent upper respiratory infection (within four weeks prior to the surgery)
- •Allergy or intolerance to clonidine
- •Non-English speaking parents/patients.
研究组 & 干预措施
1. Awake extubation/dexmedetomidine
Awake extubation receiving dexmedetomidine.
干预措施: Dexmedetomidine (Drug)
2. Awake extubation/placebo
Awake extubation receiving placebo (normal saline).
干预措施: Normal Saline (Drug)
3.Deep extubation/dexmedetomidine
Deep extubation receiving dexmedetomidine.
干预措施: Dexmedetomidine (Drug)
4. Deep extubation/placebo
Deep extubation receiving placebo (normal saline).
干预措施: Normal Saline (Drug)
结局指标
主要结局
Number of Participants With Respiratory Complications
时间窗: 24 hours
Number of patients exhibiting any of the following outcomes: 1. desaturation to less than 95% for more than 10 seconds; 2. breath holding; 3. complete or partial laryngospasm; 4. bronchospasm; 5. croup; 6. number of episodes of persistent cough (three or more consecutive coughs); 7. negative pressure pulmonary edema; 8. stridor.
次要结局
- Average Time From End of Surgery to Leaving the Operating Room(24 hours)
- The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)(24 hrs)
- Number of Participants With Emergence Agitation(24 hours)
- Number of Participants With Postoperative Nausea and Vomiting (PONV)(24 hrs)
- Number of Patients With Unplanned Hospital Admission(24 hours)
- Number of Participants Needing Follow-up Pain Medication(24 hours)
研究者
Makara Cayer
Prinicpal Investigator
Massachusetts Eye and Ear Infirmary