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临床试验/NCT05397301
NCT05397301已完成不适用

Comparison of Controlled Sedoanalgesia and General Anesthesia in Dacryocystorhinostomy Surgery

Turkish Society of Anesthesiology and Reanimation2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年2月7日最近更新:
适应症

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

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)

研究者

发起方
Turkish Society of Anesthesiology and Reanimation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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