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临床试验/CTRI/2019/05/019338
CTRI/2019/05/019338已完成3 期

Awake Mini-Craniotomy for Edematous Brain Lesions

Dr Jitin Bajaj1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年5月28日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
To evaluate the safety and efficacy of awake minicraniotomy in edematous brain lesions

研究概览

简要总结

Purpose: Introduction: Awake craniotomy has been proven to be safe and effective in several conditions including low grade gliomas, epilepsy surgeries and some vascular conditions.1–3 It provides several advantages over craniotomy in general anesthesia. Firstly, it provides the ability to use intraoperative monitoring of eloquent regions including speech, motor, and visual areas. Secondly, pulmonary complications due to intubation, ventilation etc., that can occur with general anesthesia can be avoided. Thirdly, positional complications like ulcers, spinal torsions etc. can also be prevented.

The use of newer drugs like Dexmedetomidine is an alpha-2 adrenergic agonist, have properties of sedative and analgesic effect, reduced delirium and agitation, sympatholysis, cardiovascular stabilizing effect, without respiratory depression and has proved to be safe and effective in perioperative and ICU situations.4

Awake craniotomy has been generally used in non-edematous conditions, possibly due to apprehension of intraoperative brain bulge. If done in edematous conditions, large craniotomies have been advised.5 We have reported minicraniotomy and endoscopic assisted excision of edematous lesions in the past.6 In this article we report the combined use of techniques of awake and minicraniotomy for dealing with edematous brain lesions.

References:

  1.         Gamble AJ, Schaffer SG, Nardi DJ, Chalif DJ, Katz J, Dehdashti AR. Awake Craniotomy in Arteriovenous Malformation Surgery: The Usefulness of Cortical and Subcortical Mapping of Language Function in Selected Patients. World Neurosurg. 2015;84(5):1394-1401. doi:10.1016/j.wneu.2015.06.059

  2.         Sitnikov AR, Grigoryan YA, Mishnyakova LP. Awake craniotomy without sedation in treatment of patients with lesional epilepsy. Surg Neurol Int. 2018;9:177. doi:10.4103/sni.sni_24_18

  3.         Taylor MD, Bernstein M. Awake craniotomy with brain mapping as the routine surgical approach to treating patients with supratentorial intraaxial tumors: a prospective trial of 200 cases. J Neurosurg. 1999;90(1):35-41. doi:10.3171/jns.1999.90.1.0035

  4.         Kaur M, Singh PM. Current role of dexmedetomidine in clinical anesthesia and intensive care. Anesth Essays Res. 2011;5(2):128-133. doi:10.4103/0259-1162.94750

  5.         Khu KJ, Ng WH. Intraoperative swelling leading to neurological deterioration: an argument for large craniotomy in awake surgery for glioma resection. J Clin Neurosci Off J Neurosurg Soc Australas. 2009;16(7):886-888. doi:10.1016/j.jocn.2008.10.002

  6.         Ratre S, Yadav YR, Parihar VS, Kher Y. Microendoscopic Removal of Deep-Seated Brain Tumors Using Tubular Retraction System. J Neurol Surg Part Cent Eur Neurosurg. 2016;77(04):312-320. doi:10.1055/s-0036-1580595

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Adult cooperative patients with Supratentorial edematous brain lesions.

排除标准

  • 1.Pediatric patients 2.Patient refusal 3.Patients with continuous cough, COPD, cardiac anomalies.

结局指标

主要结局

To evaluate the safety and efficacy of awake minicraniotomy in edematous brain lesions

时间窗: Baseline, 1 month, 6 months

次要结局

  • To evaluate the patient comfort during the surgery using pain scores(Same postoperative day)

研究者

发起方
Dr Jitin Bajaj
申办方类型
Other [self]

研究点 (1)

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