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临床试验/NCT04407715
NCT04407715
已完成
不适用

The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diameter in Laparotomic Gynecological Surgery

Bursa Yuksek Ihtisas Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 80 人2019年4月30日

概览

阶段
不适用
干预措施
The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater
疾病 / 适应症
Optic Nerve Sheath Diameter
发起方
Bursa Yuksek Ihtisas Training and Research Hospital
入组人数
80
试验地点
1
主要终点
Optic Nerve Sheath Diamater
状态
已完成
最后更新
2个月前

概览

简要总结

Different amounts of anesthetic gas can be used in the obstetric gynecological surgery operations to be performed with open method. Researchers aimed to compare the effect of gas changes on intraocular nerve diameter by ultrasonography.

详细描述

A total of 80 patients who underwent laparotomic gynecological surgery were divided into two groups prospectively: high flow of 2 L/min and minimal flow of 0.5 L/min. Anesthesia was maintained with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 1 (n=40) and with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 2 (n=40). After 10-15 minutes, group 2 was administered minimal flow with 50-60% oxygen-40-50% air at 0.5 L/min and desflurane, and 10 minutes before the end of the surgery, the patients were switched to high flow with 50% oxygen-50% air at 2 L/min.

注册库
clinicaltrials.gov
开始日期
2019年4月30日
结束日期
2019年12月30日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Bursa Yuksek Ihtisas Training and Research Hospital
责任方
Principal Investigator
主要研究者

Anıl Onur

Principle İnvestigator

Bursa Yuksek Ihtisas Training and Research Hospital

入排标准

入选标准

  • Aged 18-65 years
  • Who underwent laparotomic gynecological surgery

排除标准

  • Patients with obstructive pulmonary disease
  • Patients with decompensated diabetes, those with a fasting period of more than 12 hours -Acute alcohol intoxication
  • Chronic alcohol use
  • Who refuse to participate in the study
  • Who are not cooperative, do not speak Turkish
  • Who had known eye disease (glaucoma, retinal detachment), had a previous history of eye surgery,
  • Increased intracranial pressure findings (intracranial lesion, previous cerebrovascular diseases
  • Body mass index of \> 40kg/m2
  • ASA \> III

研究组 & 干预措施

High Flow Anesthesia, Low Flow Anesthesia

. The patients were randomly allocated to one of the two groups of fresh gas flows using the closed-envelope technique: 2 L/min high flow and 0.5 L/min minimal flow. Group 1 (n = 40) was operated under high flow anesthesia with 50% O2 - 50% air at 2 L/min and desflurane at 1.1 MAC for the duration of the surgery. For anesthesia maintenance, Group 2 (n=40) was administered 50% oxygen - 50% air at 2 L/min and desflurane for 10-15 minutes. After reaching 1.1 MAC, it was switched to minimal flow with 50-60% oxygen- 40-50% air at 0.5 L/min and desflurane. 10 minutes before the end of the surgery, it was switched to high flow with 50% oxygen -50% air at 2 L/min.

干预措施: The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater

Peroperetive Optic Nerve Sheath Diameter

Optic nerve sheath diameter measurements were performed by an experienced and the same anesthetist. In the measurements, the GE Healthcare Logiq e series USG device and 12-MHz linear probe were used. Longitudinal and transverse axis images were obtained on both eyelids while the patient was in the supine position. Measurements were taken 3 mm behind the optic nerve head

干预措施: The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater

结局指标

主要结局

Optic Nerve Sheath Diamater

时间窗: 2 hours operation time

Optic nerve sheath diamater measurements of the patients were recorded before and during the surgery at specified time points (T0: awake, T1: High fresh gas flow after induction at the 10th min., T2: Inhalation anesthesia at the 30th min., T3: Inhalation anesthesia at the 60th min., T4: Inhalation anesthesia at the 90th min., T5: Before extubation).A typical optic nerve sheath is generally less than 5 mm in diameter, and diameters greater than 5.5 mm predict an ICP of ≥20 cm H2O with 100% sensitivity and specifity

次要结局

  • Peroperative Complications(2 hours operation time)
  • Postoperative Complications(postop 20 minutes)

研究点 (1)

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