Comparison of Inhalational Anesthesia and Total Intravenous Anesthesia on Surgical Field Quality and Post-operative Recovery in Endoscopic Tympanoplasty
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Surgical Field Quality
研究概览
简要总结
This study aims to prospectively compare surgical field quality and intraoperative blood loss between general inhalational anesthesia to total intravenous anesthesia (TIVA) alone in subjects undergoing endoscopic ear surgery. A secondary objective is to compare rates of emergence delirium and total recovery time between the two groups.
详细描述
In sinus surgery, TIVA has been described as a possible advantage in the use of endoscopic ear surgery. However, to date, there are no studies that examine blood loss, surgical field quality, and recovery in TIVA compared to inhalational anesthesia in the setting of endoscopic ear surgery. The hypothesis is that in patients who undergo endoscopic tympanoplasty, those who receive TIVA will have reduced intraoperative blood loss, improved surgical field quality, and reduced emergence agitation than those who receive inhalational anesthesia. This study will be a prospective double-blinded randomized control trial consisting of subjects undergoing endoscopic tympanoplasty surgery to assess intraoperative blood loss, surgical field quality, rates of emergence delirium, and recovery time.
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, Care Provider)
盲法说明
In the operating room, in order to blind the surgeon to the type of anesthesia used, a surgical drape will be placed in between the subject and the anesthesia team to conceal the anesthesia machinery and equipment. A sham intravenous pole will be at the anesthesia workstation for those subjects in the control arm to contribute to the blinding of the surgeon. Patients will not be informed about which arm they are randomly assigned to and only the anesthesiologist will be aware prior to the surgery.
入排标准
- 年龄范围
- 0 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of all ages
- •Scheduled to undergo an endoscopic tympanoplasty
排除标准
- •Individuals with anticoagulation disorders
- •Those receiving anticoagulation therapy currently
研究组 & 干预措施
Inhalational Anesthesia
Adults:
The control group will receive general inhalational anesthesia (sevoflurane, isoflurane). The will be induced with fentanyl 1-2µg/kg, propofol 2mg/kg, lidocaine 1mg/kg. After orotracheal intubation, anesthesia will be maintained with isoflurane 1.5-2% or sevoflurane 1-2%.
Children (12 or younger) induced with a combination of volatile anesthetic gases, including sevoflurane (up to 8%) and nitrous oxide gas (up to 70%). Those who are older than 12 will have an intravenous line placed in the preoperative area and as such will be induced with remifentanil and propofol as above. For maintenance, children in the control arm will receive 0.6 - 1.5% sevoflurane.
干预措施: Isoflurane Inhalant Product (Drug)
Inhalational Anesthesia
Adults:
The control group will receive general inhalational anesthesia (sevoflurane, isoflurane). The will be induced with fentanyl 1-2µg/kg, propofol 2mg/kg, lidocaine 1mg/kg. After orotracheal intubation, anesthesia will be maintained with isoflurane 1.5-2% or sevoflurane 1-2%.
Children (12 or younger) induced with a combination of volatile anesthetic gases, including sevoflurane (up to 8%) and nitrous oxide gas (up to 70%). Those who are older than 12 will have an intravenous line placed in the preoperative area and as such will be induced with remifentanil and propofol as above. For maintenance, children in the control arm will receive 0.6 - 1.5% sevoflurane.
干预措施: Sevoflurane inhalant product (Drug)
Total Intravenous Anesthesia (TIVA)
Adults:
The comparator arm will receive total intravenous anesthesia (propofol and remifentanil). They will be induced with fentanyl 1-2µg/kg, propofol 2mg/kg, and lidocaine 1mg/kg. After orotracheal intubation, anesthesia will be maintained with propofol 100-200mcg/kg/min, remifentanil 0.05-2µg/kg/min.
Children (12 or younger) induced with a combination of volatile anesthetic gases, including sevoflurane (up to 8%) and nitrous oxide gas (up to 70%). Those who are older than 12 will have an intravenous line placed in the preoperative area and as such will be induced with remifentanil and propofol as above. For maintenance, they will receive 100-200mcg/min propofol and 0.05-2µg/kg/min remifentanil.
干预措施: Propofol injection (Drug)
Total Intravenous Anesthesia (TIVA)
Adults:
The comparator arm will receive total intravenous anesthesia (propofol and remifentanil). They will be induced with fentanyl 1-2µg/kg, propofol 2mg/kg, and lidocaine 1mg/kg. After orotracheal intubation, anesthesia will be maintained with propofol 100-200mcg/kg/min, remifentanil 0.05-2µg/kg/min.
Children (12 or younger) induced with a combination of volatile anesthetic gases, including sevoflurane (up to 8%) and nitrous oxide gas (up to 70%). Those who are older than 12 will have an intravenous line placed in the preoperative area and as such will be induced with remifentanil and propofol as above. For maintenance, they will receive 100-200mcg/min propofol and 0.05-2µg/kg/min remifentanil.
干预措施: Remifentanil Injection (Drug)
结局指标
主要结局
Surgical Field Quality
时间窗: Post-Operative evaluation (within 2 weeks)
Neurotologists will evaluate endoscopic video clips from each surgery to assess clarity of field at different points in the surgery using the Boezaart scale grading system. It is a scale from 0-5, with 0 being the most favorable outcome and 5 being the least favorable outcome.
Intra-operative blood loss
时间窗: 1-2 hours during surgery
Intraoperative blood loss will be determined by measuring the total number of pledgets needed to attain hemostatsis. This will be a general observation with the more pledgets needed to stop bleeding in the surgical area indicates more possible blood loss than the procedures with that require less pledgets.
次要结局
- Emergent Delirium and Recovery Time-Riker Scale(Immediately After extubation)
- Emergent Delirium and Recovery Time-Richmond Scale(Immediately After extubation)
- Post-operative pain or complications(0-1 hour post-operative)
研究者
Leslie Son
Research Scientist-Study Coordinator
Our Lady of the Lake Hospital