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Clinical Trials/CTRI/2026/01/100685
CTRI/2026/01/100685Not yet recruitingPhase 3

Safety of low dose local anesthetics for Paroxysmal Sympathetic Dysfunction

Amrita Institute of Medical sciences1 site in 1 country10 target enrollmentStarted: January 20, 2026Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Enrollment
10
Locations
1
Primary Endpoint
reduced PSH score

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

reduced PSH score

Time Frame: 0,1,2,3,4 weeks

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Ravi Sankaran

Amrita Hospitals

Study Sites (1)

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