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临床试验/NCT07407972
NCT07407972已完成不适用

Effect of Optıc Nerve Dıameter ın Tymphanoplasty Surgery Performed ın Lateral Head Posıtıon Under General Anesthesia

Bursa Yuksek Ihtisas Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2020年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
53
试验地点
1
主要终点
The effect of lateral head position on intracranial pressure

研究概览

简要总结

Studies exist to determine the effect of laparoscopic surgical procedures on increased intra-abdominal pressure; these studies include optic nerve sheath diameter (ONSD) measurement in various positions such as trendelenburg and prone, and the effect of the laryngoscope used in intubation on increased intracranial pressure. In these situations, changes in cerebral blood flow and intracranial pressure may occur due to impaired neck venous return. There are no studies in the literature regarding increased osd and consequently increased intracranial pressure in lateral head position.ultrasound for ONSD measurement is a non-invasive, rapid, and easily applicable method for diagnosing changes in intracranial pressure. In tympanoplasty surgeries, the head and neck remain in a lateral position, and venous return in the surgical field may sometimes be compressed due to the procedure. The aim of this study is to determine the effect of lateral head position and variables such as demographic data and surgical duration on increased intracranial pressure. Methods: Patients over 18 years of age, classified as asa ı and ıı, undergoing tympanoplasty surgery under general anesthesia in the lateral head and neck position will be included in the study. Patients' vital signs (arterial blood pressure, heart rate, spo2, and etco2) will be monitored regularly in the operating room before and after surgery. Demographic data (age, gender, weight, height), surgery duration, and postoperative complications will also be recorded. Anesthesia will be administered with 2-4 mg/kg propofol, 0.6 mg/kg rocuronium, and 1-2 mcg/kg fentanyl for induction, and sevoflurane for maintenance. Following intubation, onstitial lateral head and neck (onsd) measurements will be taken by the anesthesiologist at three time intervals (in transverse and sagittal planes). Both onsds will be recorded by ultrasound: T1: 5 minutes in the supine position, T2: at the end of the procedure with the head in the lateral position, and T3: before extubation in the supine position. Postoperative headache and neck pain will be inquired about after waking up and at 1., 6., and 24. hours later.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Patients over 18 years of age Patients undergoing tympanoplasty surgery under general anesthesia Patients with ASA I or II Patients scheduled for surgery in the lateral head and neck position

排除标准

  • Patients who will have neck dissection,
  • Patients who have undergone other procedures that may cause changes in -intracranial pressure,
  • Patients under 18 years of age,
  • Patients who cannot communicate,
  • Patients with glaucoma and eye disorders

研究组 & 干预措施

ONSD Measurement

Other

ONSD measurements were taken in three time intervals by the anesthesiologist: transverse and sagittal planes. Both ONSDs were recorded by ultrasound at T1: 5 min in supine position, T2: end of the procedure with head in lateral position, and T3: supine position before extubation.

干预措施: optic nerve diameter (Diagnostic Test)

结局指标

主要结局

The effect of lateral head position on intracranial pressure

时间窗: 2 years

The effect of lateral head positioning on intracranial pressure will be determined by measuring the diameter of the optic nerve sheath under ultrasound guidance.

次要结局

未报告次要终点

研究者

发起方
Bursa Yuksek Ihtisas Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

sermın emınoglu

associate professor

Bursa Yuksek Ihtisas Training and Research Hospital

研究点 (1)

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