跳至主要内容
临床试验/CTRI/2017/10/010068
CTRI/2017/10/010068进行中(未招募)不适用

To compare the increase in optic nerve sheath diameter during propofol versus sevoflurane-maintained anaesthesia in robotic-assisted laparoscopic pelvicsurgery

Max Superspeciality Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年10月28日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
1
主要终点
The change from baseline of the sonographically measured ONSD during propofol versus sevoflurane maintained anesthesia in patients undergoing robotic-assisted laparoscopic pelvic surgery.

研究概览

简要总结

1.  BACKGROUND OF TRIAL

Robotic-assisted laparoscopic pelvic surgery requires a much steeper Trendelenburg position and a higher pressure of CO2 pneumoperitoneum than in other conventional or laparoscopic surgeries. Retroperitoneal dissection also increases the absorption of CO2 . This causes several physiological changes like raised airway, abdominal, intraocular and intracranial pressures (ICP). Raised ICP can severely compromise the cerebral perfusion pressure leading to ischemia of the brain parenchyma. Ultrasonography of ONSD shows a good level of diagnostic accuracy for detecting intracranial hypertension. Hence ONSD can be used as a surrogate for direct measurement of ICP.

Both propofol and volatile anesthetics are commonly used for maintenance of anesthesia in patients undergoing robotic surgery in steep trendelenburg position. However, it has been shown in neurosurgical patients that mean ICP values are lower and cerebral perfusion pressures values higher with propofol-maintained anesthesia .

PURPOSE OF TRIAL

In our study, we aim to compare the increase in optic nerve sheath diameter from the baseline during propofol versus sevoflurane-maintained anesthesia in robotic-assisted laparoscopic pelvic surgery.

The purpose of the study is to find out whether propofol or sevoflurane based anaesthesia maintains the intracranial pressure more optimally in robotic assisted pelvic surgeries.

AIMS AND OBJECTIVES

Primary Objective:

To compare the change from baseline of the sonographically measured ONSD during propofol versus sevoflurane maintained anesthesia in patients undergoing robotic-assisted laparoscopic pelvic surgery.

Secondary Objectives:

1)    To find out any intragroup correlation in the propofol group between the total  dose of propofol used and the change in ONSD from the baseline.

2)    To find out the correlation between the change in ONSD from the baseline and the duration of surgery.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
40.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Scheduled for robotic.
  • assisted pelvic surgery.

排除标准

  • Patient refusal, history of raised intracranial or intraocular pressure.

结局指标

主要结局

The change from baseline of the sonographically measured ONSD during propofol versus sevoflurane maintained anesthesia in patients undergoing robotic-assisted laparoscopic pelvic surgery.

时间窗: Preoperative, 10 minutes postinduction of anaesthesia, post docking (30min, 1 hour, 2 hours, 3 hours, 4 hours and 5 hours), 30 min after undocking and 30 min after extubation.

次要结局

  • 1)To find out any intragroup correlation in the propofol group between the total dose of propofol used and the change in ONSD from the baseline.(2)To find out the correlation between the change in ONSD from the baseline and the duration of surgery.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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