Comparison of Controlled Sedoanalgesia and General Anesthesia in Dacryocystorhinostomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- amount of bleeding
研究概览
简要总结
In our study, we aim to compare general anesthesia and controlled sedoanalgesia methods in dacryocystorhinostomy (DCR) surgery in terms of hemodynamic data, bleeding amount, postoperative complications (bleeding, pain, etc.) and anesthesia satisfaction in a prospective and randomized controlled manner.
详细描述
The patients were routinely monitored in the operating room in accordance with the standard protocol for elective surgeries, and the preoperative findings (blood pressure, oxygen saturation, cardiac rhythm, peak heart rate) were recorded.
The decision of routine anesthesia was not interfered with. The data of the patients were collected as GA group if general anesthesia was applied and SA group if sedoanalgesia was applied. If general anesthesia was preferred, anesthesia induction was performed with propofol, fentanyl and rocuronium, and sevoflurane was used for anesthesia maintenance. Intravenous midazolam and dexmedetomidine infusions were administered to patients for whom sedoanalgesia was preferred. The sedation level of these patients was followed up with the Ramsay sedation scale (RSS) and capnography monitoring was performed.
Whether general anesthesia or sedoanalgesia was preferred, local anesthesia was administered to all patients by the surgical team and intraoperative hemodynamic data (mean arterial pressure, heart rate, oxygen saturation) were followed.
In addition to patients recruited for the study, hemodynamic data after induction, endotracheal intubation, surgical incision, and extubation were also recorded.
Depth of anesthesia was monitored with a bispectral index monitor for both groups.
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)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary DCR surgery to be performed
- •18 years and older patients
- •Having an American Society of Anesthesiology score of 1, 2, 3
- •Having approved and signed the informed consent form
排除标准
- •Patients younger than 18 years old
- •Patients with an American Society of Anesthesiology score of 4 and above
- •Patients who do not accept informed consent
- •History of drug allergy and opioid tolerance
- •Uncontrolled diabetes mellitus
- •Coagulation disorder
- •Cases with severe liver and kidney disease
- •Those who refused to participate in the study
- •They will have DCR surgery again
结局指标
主要结局
amount of bleeding
时间窗: amount of bleeding calculated during surgery
the amount that bleeds into the aspirator and cottons during the surgery (ml)
hemodynamic data
时间窗: through surgery completion
blood pressure (mm/hg)
次要结局
- postoperative complications(postoperatif 12 hour)
