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Role of Neostigmine in Snake Bite

Not Applicable
Conditions
Health Condition 1: T48- Poisoning by, adverse effect of and underdosing of agents primarily acting on smooth and skeletal muscles and the respiratory system
Registration Number
CTRI/2023/01/048800
Lead Sponsor
nil
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

a)Aged 13 years and above

b)Neuroparalytic snakebite patients, with typical symptoms occurring within 24 hours

c)Neuroparalytic symptoms manifesting as: dyspnea, dysphonia, dysarthria, diplopia, dysphagia, ptosis, paralysis

d)Other signs of impending respiratory failure i.e. diminished or absent deep tendon reflexes and head lag

e)Additional features like stridor, ataxia; associated hypertension and tachycardia

f)Willing to sign voluntarily a statement of written informed consent/assent to participate in the study

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Composite End Point of need and duration of ventilatory support after neostigmine administration: Number of patients requiring mechanical ventilation after neostigmine administration including, along with the duration of ventilatory support will be evaluated as a composite endpointTimepoint: time of admission to discharge
Secondary Outcome Measures
NameTimeMethod
A)Duration of hospital stay <br/ ><br>B)Time taken for recovery of PaCO2 retention (PaCO2 45 mm Hg) <br/ ><br>C)Changes in routine blood parameters: complete hemogram, Liver function test/Renal function test, coagulogram, blood gas analysis, blood sugar, serum amylase <br/ ><br>D)Number of subjects experiencing any adverse event(s) <br/ ><br>E)Plasma levels of possible biomarkers: PLA2, Cystatin C, IL-1, 6, 17, TNF-α, NF-�� <br/ ><br>F)Death: incidence of all-cause mortality will be evaluated <br/ ><br>Timepoint: time of admission to discharge
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