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临床试验/CTRI/2026/02/104597
CTRI/2026/02/104597尚未招募不适用

Effect of intraoperative mannitol on optic nerve sheath diameter in patients undergoing total laparoscopic hysterectomy : A double blind randomised study

Sir Ganga Ram Hospital, New Delhi1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2026年4月1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
42
试验地点
1
主要终点
ONSD- will be measured at different time interval

研究概览

简要总结

Total laparoscopic hysterectomy is a popular and rapidly growing surgical alternative technique in gynaecological surgeries as they offer significant advantages i.e. minimal invasion, reduced bleeding, reduced postoperative pain which translate into shorter hospital stay. These approaches present unique challenges to the anaesthesiologists in terms of Trendelenburg position along with pneumoperitoneum. These procedures result in increase in intracranial pressure (ICP) due to Trendelenburg positioning and pneumoperitoneum. A raised intra cranial pressure (ICP) can result in decreased cerebral perfusion pressure (CPP), which in turn can cause cerebral ischemia and delayed recovery.

A simple, non-invasive and reproducible bedside technique for assessment of intracranial pressure (ICP) is sonographically measured optic nerve sheath diameter (ONSD). Increase in optic nerve sheath diameter (ONSD) is surrogate for increase in intracranial pressure (ICP). Mannitol, a hyperosmolar agent, is widely used in anaesthesia practice as a diuretic. Mannitol exerts its diuretic effect by decreasing the reabsorption of water and sodium across the renal tubules. Mannitol has been used to counter the increase in intracranial pressure in a variety of clinical situations. It is also being used in laparoscopic surgeries in Trendelenburg position. However no formal study has been done on this. Therefore, further research is needed to substantiate its use in this clinical situation.

  We will enroll a minimum of 42 patients who will be scheduled to undergo total laparoscopic hysterectomy in Trendelenburg position. These patients will be divided in two groups (study and placebo group) and a randomized study will be conducted to study the effect of intraoperative mannitol on optic nerve sheath diameter in patients undergoing total laparoscopic hysterectomy. The primary objective of the study is to measure the effect of

intraoperative mannitol on optic nerve sheath diameter in patients undergoing total laparoscopic hysterectomy between the two study groups. The secondary objectives is to study the cognitive dysfunction between the two study groups. All the patients undergoing total laparoscopic hysterectomy will be screened, and those found eligible will be enrolled. Enrolled patients will be divides in two groups. Group M will receive IV infusion of 20% mannitol (0.5g/kg i.e. 2.5ml/kg) given over a duration of 30 minutes and group N will receive placebo (normal saline) by the same route. The primary objective of the study is to measure the intraoperative effect of mannitol on optic nerve sheath diameter in patients undergoing total laparoscopic hysterectomy between the two study groups. We hypothesize that the use of mannitol will prevent the increase of intracranial pressure during total laparoscopic hysterectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Age 18-65 years.
  • ASA physical status I and II.
  • Patients scheduled for elective total laparoscopic hysterectomy.

排除标准

  • Non consenting Patients
  • Patients with severe Cardiac or pulmonary disease
  • Patients with pre-existing glaucoma/ocular surgery
  • Patients with pre-existing raised intracranial pressure/ cerebellar vascular disease
  • Patients with active intracranial bleed
  • History of allergy to mannitol
  • Combined with any other surgery.

结局指标

主要结局

ONSD- will be measured at different time interval

时间窗: T0 5 minutes after induction | T1 5 minutes after Trendelenburg position | T2 30 minutes after Trendelenburg position | T3 60 minutes after Trendelenburg position | T4 90 minutes after Trendelenburg position | T5 120 minutes after Trendelenburg position | T6 5 minutes after desufflation

次要结局

  • Recovery from anaesthesia:(Extubation time)

研究者

发起方
Sir Ganga Ram Hospital, New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR ASHWIN MARWAHA

Sir Ganga Ram Hospital

研究点 (1)

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