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临床试验/NCT04434651
NCT04434651已完成不适用

Effect of Sphenopalatine Ganglion Block on Intracranial Pressure and Cerebral Venous Outflow Oxygenation During Craniotomy for Supratentorial Brain Tumors.

Zagazig University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2020年6月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Intracranial Pressure

研究概览

简要总结

This study aims to investigate the effect of Sphenopalatine Ganglion Block on ICP and arterio- jugular venous oxygen difference (AJVDO2) and jugular bulb oxygen saturation (SjVO2). Throughout this study, the efficacy of Sphenopalatine Ganglion Block as scalp block in craniotomy operation will be assessed, and the effect of SPGB on cerebral hemostasis during craniotomy will be evaluated by monitoring of both ICP, AJVDO2 and SjVO2.

详细描述

This study was performed in the Neurosurgical operating room and included 52 patients allocated into two groups: the treatment group (block group) and the control group (non-block group). 26 patients enrolled in block group and 26 patients in non-block group.

Intraoperative ICP monitoring by subdural ICP monitors will be done every 20 minutes in both block and non- block groups until craniotomy has been occurred, then at the time of closure of the dura . Arterio- jugular venous oxygen difference and Jugular venous bulb oxygen saturation changes will be recorded every 20 minutes in block and non- block groups throughout time of the surgery till closure of the dura.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who prepared for a neurosurgical intervention for elective supratentorial tumor removal
  • •ASA 1 and 2
  • •Age above 18 years and below 65 years
  • •Fully conscious patients.

排除标准

  • •Patients with cardiovascular and respiratory diseases
  • •Pregnancy
  • •Patient refusal

研究组 & 干预措施

Block group (A)

Experimental

26 patients who will be subjected to a neurosurgical intervention for removal of supratentorial brain tumor. Supratentorial brain tumors with shift of the mid-line <10 mm evaluated by CT scan [computerized tomography] . SPGB will be performed using 2 % lidocaine before induction of anesthesia.

The anesthesia induced by IV anesthetics and maintained by Isoflurane. ICP, Jugular venous bulb oxygen saturation, and AVDO2 will be assessed every 20 minutes.

干预措施: SPGB (Procedure)

control sham group (B)

Sham Comparator

26 patients who will be subjected to a neurosurgical intervention for removal of supratentorial brain tumor. Supratentorial brain tumors with shift of the mid-line <10 mm evaluated by CT scan [computerized tomography] . SPGB will be performed using normal saline.The anesthesia induced by IV anesthetics and maintained by Isoflurane. ICP, Jugular venous bulb oxygen saturation, and AVDO2 will be assessed every 20 minutes

干预措施: SPGB (Procedure)

结局指标

主要结局

Intracranial Pressure

时间窗: Every 20 minutes until time of initial craniotomy, then again after the dura was sutured.

ICP changes checked by a subdural ICP monitor that positioned after the first burr hole at the opposite side of the tumor immediately after induction of anesthesia. ICP monitoring will be conducted every 20 minutes until time of initial craniotomy and at time of closure of the dura.

次要结局

  • Jugular venous bulb oxygen saturation and cerebral arteriovenous oxygen content difference.(Every 20 minutes throughout the operation period.)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Naglaa Fathy Abdelhaleem Abdelhaleem

Lecturer, Anesthesia and Surgical Intensive Care Department, Faculty of Medicine

Zagazig University

研究点 (1)

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