Role of Neostigmine in Snake Bite
- 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
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
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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