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临床试验/NCT04413903
NCT04413903已完成不适用

The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations

Bursa Yuksek Ihtisas Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2017年12月1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
60
试验地点
2
主要终点
Optic nerve sheath diameter (milimeter)

研究概览

简要总结

During surgery, researchers use different methods in respiratory equipment. In the study researchers examine the effects of these methods on intraocular pressure changes by looking at the intraocular nerve diameter. Then look at the effects of these effects on patients conscious functions by asking some questions.

详细描述

According to the mechanical ventilator application to be applied to the patients; Group P (n: 30) pressure controlled ventilation (PCV), Group V (n: 30) volume controlled ventilation (VCV) are randomly assigned to two groups. General anesthesia will be applied to all patients. Mechanical ventilation settings will be able to 8ml / kg TV (tidal volume). Demographic data (age, gender, weight, height) of patients, duration of surgery and peroperative complications will be recorded choosen time intervals.T0: awake, T1: 5th min after induction, T2: Gas insufflation start in supine position, T3: Maximum gas pressure is reached in reverse trendelenburg position, T4:Before extubation. SAB, DAB, OAB, KAH, SpO2, Ppeek, PEEP, EtCO2, optic nerve diameter will be recorded at same times. Cognitive function test will be performed at postoperative 24th hour for comparing the first awaken routin MMDT (Mini Mental Status Detection) scale. The same test will be repeated for patients who are called for routine general surgery outpatient control 3 months after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years old

排除标准

  • Unable to cooperate
  • Presence of eye disease (detachment, retinapathy, glaucoma)
  • Presence of a previous eye operation
  • Those with symptoms of KIBAS (intracranial pressure increase syndrome) (Intracranial lesion, previous cerebrovascular diseases)
  • BMI (body mass index> 40 kg / m2
  • Obstructive and restrictive lung disease
  • Pulmonary Hypertension
  • Congestive Heart Failure

结局指标

主要结局

Optic nerve sheath diameter (milimeter)

时间窗: 2 hours operation time

Optic nerve sheath diameter; It was measured from the optic nerve sheath 3 mm behind the optic disc from the closed upper eyelid. T0: Awake, T1: 5th minute after induction, T2: Gas insufflation start in supine position, T3: Maximum gas pressure is reached in reverse trendelenburg position, T4: Before extubation in supine position. 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 cmH2O .

Cognitive Function

时间窗: 3 months after surgery

Cognitive function test with Mini Mental Conditioning Scale was performed to the patients before the anesthesia induction and 3 months after the surgery . Mini Mental Scale points are between 0 and 30.

次要结局

  • Peroperative Complications(2 hours operation time)

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

Umran Karaca

Principle İnvestigator

Bursa Yuksek Ihtisas Training and Research Hospital

研究点 (2)

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