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临床试验/CTRI/2024/09/074363
CTRI/2024/09/074363
尚未招募
不适用

Comparison of supine vs trendelenburg position on optic nerve sheath diameter in laparoscopic surgery

Dayanand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月6日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Dayanand Medical College and Hospital
入组人数
40
试验地点
1
主要终点
The primary outcome is to measure the change in optic nerve sheath diameter on changing position from supine to trendelenburg position in elective laparoscopic surgeries as a surrogate marker for increased intracranial pressure.

概览

简要总结

Laparoscopic surgeries are widely used nowadays as an alternative over open surgeries for various procedures due to its minimal invasiveness, reduced hemorrhage risk, lower post operative pain and early discharge. However, in abdominal and laparoscopic surgeries, Trendelenburg position is often used for better surgical field exposure but postoperatively there are common incidences of delirium, cognitive dysfunction, conjunctival edema which can be attributed to increased intracranial pressure (ICP). This can result in acute rise in ICP which decreases cerebral perfusion pressure and can be deleterious increasing chances of morbidity and mortality. Thus, monitoring ICP during laparoscopic surgery might prevent such complications and enhance recovery.Thus, Optic nerve sheath diameter (ONSD) measurement with ultrasound has emerged as a simple, non-invasive and reliable surrogate of invasive ICP measurement. A prospective, randomized observational study will be conducted on a total of 40 adult patients planned for laparoscopic surgeries in trendelenburg position under general anaesthesia. The technique for general anaesthesia will be standardized in all patients. The ultrasonographic optic nerve sheath diameter measurements will be taken after 5 mins of induction in supine position and then in trendelenburg position after achieving adequate pneumoperitoneum and later after 5 mins of turning back to supine position post-surgery. Our aim of the study will be to quantitatively measure the ICP changes in supine and trendelenburg position using optic nerve sheath diameter changes in patients undergoing laparoscopic surgery and to assess effect of changing position from supine to trendelenburg position changes optic nerve sheath diameter. The primary outcome will be to measure the change in onsd on changing position from supine to trendelenburg position in elective laparoscopic surgeries as a surrogate marker for increased intracranial pressure. The secondary outcome will be the impact of duration of trendelenburg position in surgery on onsd patients undergoing elective laparoscopic surgeries and the impact of angle of trendelenburg position in surgery on onsd on changing position from supine to trendelenburg position undergoing elective laparoscopic surgeries.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Day(s) 至 65.00 Day(s)(—)
性别
All

入选标准

  • Adult either sex patients aged between 18 to 65 yrs of ASA grade 1to 4 planned for elective laparoscopic surgeries in trendelenburg position.

排除标准

  • Patient refusal
  • History of pre-existing ophthalmic diseases (e.g. cataract, glaucoma, retinal detachment) and ophthalmic surgeries.
  • History of neurologic disease i.e. brain injury, epilepsy, parkinsonism, intracranial lesion, stroke.
  • Change of surgical plan from laparoscopic to open surgery.

结局指标

主要结局

The primary outcome is to measure the change in optic nerve sheath diameter on changing position from supine to trendelenburg position in elective laparoscopic surgeries as a surrogate marker for increased intracranial pressure.

时间窗: The patients will be observed firstly in supine position at 5 mins after induction of general anaesthesia and secondly, in trendelenburg position after achieving pneumoperitoneum and third, 5 mins after turning back to supine post-surgery after desufflation of pneumoperitoneum.

次要结局

  • The impact of duration of trendelenburg position in surgery on optic nerve sheath diameter patients undergoing elective laparoscopic surgeries.(The patients will be observed firstly, in supine position at 5 mins after induction of general anaesthesia & secondly, in trendelenburg position after achieving pneumoperitoneum & third, 5 mins after turning back to supine postsurgery after desufflation.)
  • The impact of angle of trendelenburg position in surgery on optic nerve sheath diameter patients undergoing elective laparoscopic surgeries.(The patients will be observed firstly, in supine position at 5 mins after induction of general anaesthesia & secondly, in trendelenburg position after achieving pneumoperitoneum & third, 5 mins after turning back to supine postsurgery after desufflation.)

研究者

发起方
Dayanand Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Mirley Rupinder Singh

Dayanand Medical College and Hospital

研究点 (1)

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