Health Condition 1: T48- Poisoning by, adverse effect of and underdosing of agents primarily acting on smooth and skeletal muscles and the respiratory system
Conditions
Interventions
Intervention1: neostigmine: Group 1: Standard of care + IV Neostigmine (1.5 mg) stat and repeat dose of neostigmine 0.5 mg every 30 minutes for up to 5 doses, as required
Control Intervention1: Neosti
Sponsors
nil
Eligibility
Inclusion criteria
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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| A) Duration of hospital stay B) Time taken for recovery of PaCO2 retention (PaCO2 45 mm Hg) C) Changes in routine blood parameters: complete hemogram, Liver function test/Renal function test, coagulogram, blood gas analysis, blood sugar, serum amylase D) Number of subjects experiencing any adverse event(s) E) Plasma levels of possible biomarkers: PLA2, Cystatin C, IL-1, 6, 17, TNF-α, NF-ï?«ï?¢ F) Death: incidence of all-cause mortality will be evaluated Timepoint: time of admission to discharge | — |
Countries
India
Contacts
Public ContactShreya Gupta
PGIMER
Outcome results
None listed