Comparison Of Different Anesthetic Techniques In Children Undergoing Esophagogastroduodenoscopies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Number of Participants With Respiratory Complications
研究概览
简要总结
The purpose of this research study is to compare the safety and effectiveness of three commonly used techniques for delivering anesthesia during a procedure known as esophagogastroduodenoscopy.
详细描述
Different anesthetic techniques are currently in use at Cincinnati Children's Hospital Medical Center (CCHMC) for delivering anesthesia during an esophagogastroduodenoscopy (EGD). Because there is a lack of evidence to delineate the best techniques, pediatric anesthesiologists select the technique based on clinical preference and experience. One anesthetic technique involves the use of general anesthesia with the placement of an endotracheal tube, and maintenance with an inhalation agent, such as sevoflurane (IS). These patients may be extubated under deep anesthesia in the operating room, and allowed to awaken in the post anesthesia care unit. A similar technique involves the placement of an endotracheal tube, and anesthetic maintenance with a continuous infusion of propofol (IP). These patients are also extubated under deep anesthesia in the operating room, and allowed to awaken in the postoperative care unit. The third technique does not use an endotracheal tube and anesthetic maintenance occurs with continuous infusion of propofol with the patient breathing oxygen through their natural airway (NA). Our objective in this study is to compare outcomes between these three established anesthetic techniques.
Children in the study will be recruited from Cincinnati Children's Hospital Medical Center Operating Room Schedule. They will be cared for in the Operating Rooms and Post Anesthesia Care Unit.
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
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient presenting as out-patients, scheduled to receive an anesthetic for a diagnostic EGD
- •Patient must be a candidate for any of the three anesthetic techniques. This decision will be made by a staff member of the Department of Anesthesiology, who is not a member of the study team and will be responsible for obtaining consent for anesthesia
- •Patient must be between ages 1 and 12 years (inclusive)
- •Patient must be American Society of Anesthesiology (ASA) class I or II;
- •Eosinophilic esophagitis (EE) patients classified as an ASA III status for their EE diagnosis only
- •Patient must have fasted according to CCHMC policy
- •Patient's legally authorized representative has given written informed consent to participate in the study and, when appropriate, the subject has given assent to participate
排除标准
- •Patients less than a year old and greater than 12 years old
- •Patients undergoing therapeutic upper endoscopy
- •Patients with an ASA physical status III or greater (other than EE patients)
- •Patients with history of allergy to propofol, any other drug in the protocol, or eggs (exclusive of egg allergies identified only by skin testing or manifested only by gastrointestinal symptoms)
- •Patients with personal or family history of malignant hyperthermia
- •Obese patients (Body mass index more than 95th percentile for age)
- •Patients with significant airway abnormalities (e.g., trisomy 21, craniofacial syndromes, sub-glottic stenosis, tracheomalacia, tracheostomy)
- •Patients with history of obstructive sleep apnea
- •Patient receiving sedative premedication
- •Patient previously treated under this protocol
- •Patients with symptoms of an active upper respiratory infection
- •Patients with history of coagulopathy
- •Patients with esophageal varices or gastrointestinal bleeding
研究组 & 干预措施
Intubated with Sevoflurane (IS)
Anesthetic technique during (EGD)
干预措施: Intubated with Sevoflurane (IS) (Drug)
Intubated with Propofol (IP)
Anesthetic technique during (EGD)
干预措施: Intubated with Propofol (IP) (Drug)
Native Airway - no intubation
Anesthetic technique during (EGD)
干预措施: Zofran - no intubation (Drug)
Native Airway - no intubation
Anesthetic technique during (EGD)
干预措施: Propofol (Drug)
结局指标
主要结局
Number of Participants With Respiratory Complications
时间窗: Admission for surgery through recovery period, approximately 3 hours
An important outcome in the anesthetic management of these patients is to maintain a balance between a safe technique with a minimal incidence of respiratory complications, and a technique that facilitates rapid turnover of the gastrointestinal suite. A chi-square test, or Fisher's exact test will measure differences among the three anesthetic groups. Different anesthetic techniques are currently in use at Cincinnati Children's Hospital Medical Center (CCHMC). Because there is a lack of evidence to delineate the best techniques, pediatric anesthesiologists select the technique based on clinical preference and experience.
次要结局
- Peri-operative Times Between Three Different Anesthetic Techniques(Admission for surgery through recovery period, approximately 3 hours)