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临床试验/NCT05268900
NCT05268900Unknown不适用

Effect of Different Ventilation Modes on Intracranial Pressure During Laparoscopic Colectomy Guided by Optic Nerve Sheath Diameter Measurement.

Mansoura University2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2022年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
78
试验地点
2
主要终点
Changes in ONSD O(optic) N(nerve) S(sheath) D(diameter)

研究概览

简要总结

Patients who undergo laparoscopic surgery often experience increased intracranial pressure (ICP). In laparoscopic colectomy surgery, the duration always exceeds 2h with more liability to changes in arterial blood gases, hemodynamics, also the patient is in Trendelenburg position about 30° head down, Trendelenburg position is believed to create changes in hemodynamics, respiratory mechanics, metabolic response, and ICP as it affects vital organs especially if steep positioning. Various modes of mechanical ventilation have been experimented to achieve good intraoperative oxygenation which may cause changes in arterial blood gas values and hemodynamic parameters that might lead to changes in the ICP. In this study we will measure ONSD, basal, intraoperative, and in the PACU to evaluate the effect of different ventilation modes (both VCV mode and PCV-VG mode) on intracranial pressure.

详细描述

The aim of the current study is to compare the effect of volume control ventilation (VCV) versus pressure control ventilation-volume guaranteed (PCV-VG) as modes of mechanical ventilation on ICP by US guided ONSD measurement during laparoscopic colectomy,

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index less than 30
  • American Society of Anesthesiologist physical class I -III.

排除标准

  • Patient refusal
  • operative time < 2 hour (h)
  • Patients with preexisting eye disease.
  • History of eye surgery
  • Optic nerve disease.
  • Causes of elevated ICP.

结局指标

主要结局

Changes in ONSD O(optic) N(nerve) S(sheath) D(diameter)

时间窗: Changes from baseline, till 30 minutes after recovery from anaesthesia

ONSD is the acronym of O(optic) N(nerve) S(sheath) D(diameter), that ONSD is a non invasive method for measurement of intracranial pressure The optimal cutoff value has not been established, they vary between 4.85 and 5.9 mm and \>5.9 mm is a sure sign of increased intracranial tension

次要结局

  • Heart rate(Changes from baseline, till 30 minutes after recovery from anaesthesia)
  • Mean arterial blood pressure(Changes from baseline, till 30 minutes after recovery from anaesthesia)
  • Peak airway pressure(intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).)
  • Plateau airway pressure(intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).)
  • mean airway pressure(intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).)
  • PaCO2 (carbon dioxide tension)(Changes from baseline, till 30 min after recovery from anesthesia.)
  • pH(Changes from baseline, till 30 min after recovery from anesthesia.)
  • Dynamic Lung compliance(intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).)
  • Static Lung compliance(intra-operative changes from (post induction) just after induction of anesthesia and intubation, till the end of surgery (before extubation).)
  • Headache(for 24 hour after surgery)
  • Postoperative nausea and vomiting(for 24 hour after surgery)
  • PaO2 (partial pressure of arterial oxygen)(Changes from baseline, till 30 min after recovery from anesthesia)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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