跳至主要内容
临床试验/CTRI/2026/01/100685
CTRI/2026/01/100685尚未招募3 期

Safety of low dose local anesthetics for Paroxysmal Sympathetic Dysfunction

Amrita Institute of Medical sciences1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年1月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
10
试验地点
1
主要终点
reduced PSH score

研究概览

简要总结

Hypoxic–ischemic encephalopathy (HIE) occurs after global cerebral ischemia and can lead to outcomes ranging from persistent vegetative state to complete recovery. The management of HIE is multidisciplinary and offered to medically stable individuals. Paroxysmal Sympathetic Hyperactivity (PSH), also called Paroxysmal Autonomic Instability with Dystonia (PAID), occurs in 7–33% of HIE cases within the first three months. PSH presents with agitation, sweating, fever, high blood pressure, fast heart rate, rapid breathing, and extensor posturing. Standard drugs used include morphine, bromocriptine, propranolol, clonidine, lorazepam, and dantrolene, yet outcomes often remain poor with prolonged care and minimal functional gains. Neural therapy, which uses low-dose short-acting local anesthetics at autonomic structures, has shown promise in reducing autonomic dysfunction through blocks of the stellate ganglion or vagus nerve. The primary aim of this pilot study was to test the feasibility of such low-dose blocks in PSH, with secondary aims of assessing PSH score changes, DLT score, and treatment-related adverse events. The study was conducted in a tertiary rehabilitation center with ethics approval (ECASM-AIMS-2025-165, CTRI registered), and informed consent was obtained from families. Eligible patients had HIE within three months, were off ventilator and inotropes, had CRS-R scores between 3 and 8, radiological stage 3 injury, unresolved PSH for one week post-ICU, a DLT score of 5+, were on maximum tolerated propranolol, and had no active infection or comorbidities. Patients received six injections weekly for four weeks, with anesthetic blocks of the stellate and vagus nerves under ultrasound guidance, and outcomes were tracked using validated PSH and DLT scoring systems.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • were Hypoxic Ischemic Encephalopathy within the first three months, not on a ventilator or inotropic support, CRS-R 3 to 8, radiological grading stage 38, storming by PSH criteria 9, PSH not resolving a week from coming out of ICU, DLT score of 5+, propranolol at maximum tolerate doses, minimal acute phase reactant elevation and culture negative.

排除标准

  • were requiring celiac ganglion block,sepsis concomitant UTI, upper GI bleed confirmed by occult blood testing, and comorbid Psychiatric Orthopedic, or Neurological conditions.

结局指标

主要结局

reduced PSH score

时间窗: 0,1,2,3,4 weeks

次要结局

  • estimate the change in PSH and DTC and evaluate the toxicities and adverse events associated with delivering multiple doses of low dose local anesthetic.(0,1,2,3,4 weeks)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Ravi Sankaran

Amrita Hospitals

研究点 (1)

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