跳至主要内容
临床试验/CTRI/2022/10/046194
CTRI/2022/10/046194尚未招募不适用

The effect of different pressures of pneumoperitoneum on the optic nerve sheath diameter (ONSD) - prospective study

Esic medical college and hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年10月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
measurement of optic nerve sheath diameter (ONSD) as a noninvasive alternative to intracranial pressure (ICP)

研究概览

简要总结

Laparoscopic surgery is a unique, minimally invasive technique and a key tool in various therapeutic and diagnostic procedures. In performing this minimal access procedure carbon dioxide (CO2) pneumoperitoneum is created for visualization and to allow surgical manipulation.Increased intra-abdominal pressure (IAP) and CO2 gas during pneumoperitoneum leads to various systemic changes involving cardiovascular, respiratory and cerebral physiology. Though these physiological changes well tolerated by healthy individuals, may have adverse consequences in elderly with borderline organ function and critically ill patients. Conventional method of gas insufflation during laparoscopic surgeries leads to IAP of 12-16 mmHg (standard IAP). It was emphasizedthat with low pressure pneumoperitoneum (IAP <10mmHg) there is less postoperative pain, better hemodynamics, reduced surgical events and also has neuro-protective effect.Several studies documented the effect of raised IAP on intra cranial pressure (ICP). The mechanisms of increase of ICP during laparoscopy may be due to increase IAP impeding drainage of the lumbar venous plexus, impairment of cerebrospinal fluid (CSF) absorption and cerebral vasodilation due to hypercarbia. Raised ICP may cause significant neurological complications. Various methods are used in measuring ICP, which are invasive and time consuming. The optic nerve sheath is in continuity with the dura mater, surrounded by subarachnoid space which is continuous with intracranial subarachnoid space. So any change in ICP is transmitted to optic nerve sheath. Optic nerve sheath diameter (ONSD) measured by ultrasonography a non-invasive imaging technique, is a safe and accurate method in diagnosing increased ICP. In our study we plan to investigate the effect of standard (13-15mmHg) and low (6-8mmHg) pressure pneumoperitoneum on intracranial pressure (ICP) using ultrasound measurements of optic nerve sheath diameter (ONSD).

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA physical status I and II.
  • Age between 18 –60 years.
  • 3.The patients scheduled for elective laparoscopic surgery under general anesthesia.
  • 4.Informed written consent.

排除标准

  • 1.Patient refusal.
  • 2.ASA group 3 and 4, Emergencies 3.Pregnancy 4.Patients with head injury, space occupying lesions of brain 5.Cases converted to open laparotomy •Patients with any significant systemic illness.

结局指标

主要结局

measurement of optic nerve sheath diameter (ONSD) as a noninvasive alternative to intracranial pressure (ICP)

时间窗: intraoperatively

次要结局

  • hemodynamics(intraoperatively)

研究者

发起方
Esic medical college and hospital
申办方类型
Government medical college

研究点 (1)

Loading locations...

相似试验