Rajiv Gandhi University of Health sciences,



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

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|01 |Name of candidate and address |DR.SRIHARSHA.J |

| |(in block letters) |No 1139 2ND CROSS |

| | |PADUVANA ROAD |

| | |KUVEMPUNAGAR |

| | |MYSORE 570023 |

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|02 |Name of institution |KEMPEGOWDA INSTITUTE |

| | |OF MEDICAL SCIENCES(KIMS) |

| | |K.R.ROAD, V.V.PURAM, |

| | |BANGALORE 560004. |

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|03 |Course of study and subject |M.D EMERGENCY MEDICINE |

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|04 |Date of admission to course |1/06/13 |

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|05 |Title of the Topic: |

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| |“A Clinical Study of Intravenous Magnesium sulphate in the treatment |

| |of Acute Organophosphate poisoning”. |

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|6.0 |Brief Resume of the intended work |

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|6.1 | |

| |Need for the study: |

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| |Organophosphorus poisoning (OP) is the most common poisoning in India because of its easy availability. Organophosphorus |

| |pesticides are used widely for agriculture, vector control, and domestic purposes. Despite the apparent benefits of these |

| |uses acute organophosphorus pesticide poisoning is an increasing worldwide problem, particularly in rural areas. |

| |Organophosphorus pesticides are the most important cause of severe toxicity and death from acute poisoning worldwide, with |

| |more than 2,00,000 deaths each year in developing countries. Unintentional and intentional OP poisonings continue to be a |

| |significant cause of morbidity and mortality in India 1. |

| | |

| |Basic steps involved in the treatment of poisoning are(1)Prevention of further absorption of the poison( emesis, gastric |

| |lavage, chemical absorption, chemical inactivation, purgation) (2) Enhanced elimination of the poison ( biotransformation, |

| |biliary excretion, urinary excretion, dialysis) and (3)Antagonism and chemical inactivation of the absorbed drug.2 |

| | |

| |Although atropine and oximes (pralidoxime or obidoxime) are traditionally used in the management of such poisoning, their |

| |efficacy remains a major issue of debate; thus, the goal of this prospective clinical trial was to elaborate the value of |

| |magnesium sulfate (MgSO4) in the management and outcome of OP insecticide poisoning.6 |

| | |

| |Conventional treatment with atropine may lead to CNS toxicity, although control of secretions may still be inadequate. |

| |Magnesium sulphate is an inhibitor of acetylcholine release in the central nervous system and at peripheral sympathetic and|

| |parasympathetic synapses. Magnesium sulphate blocks ligand-gated calcium channels, resulting in reduced acetylcholine |

| |release from pre-synaptic terminals, thus improving function at neuromuscular junctions, and reduced CNS over-stimulation |

| |mediated via NMDA receptor activation. The administration of magnesium to animals poisoned with organophosphorus pesticides|

| |improves outcome, possibly owing to a favourable effect on neuromuscular junction block or increased hydrolysis of some |

| |pesticides. 6 |

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| |In view of the above, the present project is proposed with the aim of comparing treatment between atropine and pralidoxime |

| |with/without addition of magnesium sulphate in OP poisoning. |

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|6.2 | |

| |Review of literature: |

| |In a unicenter, randomized, single-blind trial study was conducted on patients who were acutely poisoned with Ops. |

| |Magnesium sulfate was administered at dose of 4 g/day i.v. continued for only the first 24 hours after admission. The |

| |mortality rate and hospitalization days of patients who received MgSO4 treatment were significantly lower than those who |

| |had not received MgSO4 (P < 0.01). It is concluded that administration of MgSO4, in a dose of 4 g/day concurrent to |

| |conventional therapy, in OP acute human poisoning is beneficial by reducing the hospitalization days and rate of mortality3|

| | |

| |A similar small randomised study with 4 gm magnesium in acute OP poisoning has been reported to decrease mortality .This |

| |study was very small; numerous parts of the methodology were incompletely described. Thus we believe further research is |

| |required before this treatment can be universally recommended.4 |

| | |

| |A Phase II trial was run in 4 sequential groups of patients. Six patients died in control group compared to 3 in 4 gm, 2 |

| |in 8 gm and 1 in 12 gm group. There was no mortality in 16 gm group. It was concluded that adverse effects could be |

| |attributed to intermittent bolus injections of magnesium doses (up to 16 grams). Larger controlled studies should be |

| |performed to determine the efficacy of magnesium sulfate in OP poisoning.5 |

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|6.3 |Objectives of the study |

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| |To assess the usefulness of MgSo4 in acute OP poisoning in terms of mortality and morbidity |

| |To find out the effect of Standard 4gm dose of MgSo4 over 24hours on mortality and morbidity of organophosphorous |

| |poisoning |

| |To assess merits and demerits of use of MgSo4 with conventional therapy |

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|7.0 |Materials and Methods |

| |All patients with history of organophosphorous poisoning will be included in the study. |

| |All patients will be decontaminated, treated with gastric lavage and standard treatment iv atropine and iv pralidoxime will|

| |be given as per guidelines |

| |Consecutive patients will be administered with 4grams of iv magnesium sulphate infusion in 100ml of NS over 1hr |

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| |Source of data |

| |Data will be collected from all In-patients who fulfill the inclusion and exclusion criteria and are admitted in the ICU |

| |and Emergency wards of Kempegowda institute of medical sciences Hospital with history of OP poisoning. |

| |Inclusion criteria |

| |Patients admitted with history of OP compound poisoning within 24 hours of consumption |

| |Patients/attenders who are willing to give written informed consent. |

| |Exclusion criteria |

| |Patients with Renal dysfunction |

| |Organophosphorous compound mixed with other compounds |

| |Contraindications for MgSo4 therapy |

| |Heart block |

|7.1 | |

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|7.2 |Duration of study: The study will be conducted for a period of 18 months |

| |Sample design : purposive sampling |

| |Sample size:50 |

| |Place of study: KIMS Bangalore |

| |Type of study: Comparative Interventional study |

| |Analysis of outcome measures: chi-square test |

| | |

| |Does the study require any investigation or intervention to be conducted on |

|7.3 |patients or other humans? |

| |Yes, The study involves collection of data and intervention with intravenous magnesium sulphate to the patients admitted to|

| |the hospital due to OP poisoning. |

| | |

| |Has ethical clearance been obtained from your institution in case of 7.3? |

|7.4 |Yes. |

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| | |

| |References: |

|7.5 | |

| |Roberts Darren M, Aaron Cynthia K. Management of acute organophosphorus pesticide poisoning. BMJ 2007; 334:629-634. |

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| |Brunton Laurence L. Principles of toxicology and treatment of poisoning. In: Klaassen Curtis D, editor. Goodman and |

| |gilman’s the pharmacological basis of therapeutics. New York(NY): McGraw-Hill; 2006. 1156-1159. |

| | |

| |Pajoumand A, Shadnia S,Razaie A. Benefit of magnesium sulphate in |

| |the management of acute human poisoning by organophosphorus insecticides. Hum Exp Toxicol. 2004;23:565-9. |

| | |

| |. A.Basher , S. H. Rahman , A. Ghose , S. M. Arif , M. A. Faiz , and A. H.Dawson. a pilot trail in Dhaka medical college|

| |, Bangladesh. Acessesed 2013-11-26 |

| | |

| |A.Basher , S. H. Rahman , A. Ghose , S. M. Arif , M. A. Faiz , and A. H.Dawson . Phase II study of magnesium sulfate in |

| |acute organophosphate pesticide poisoning. Clinical Toxicology 2013: 51, 35–40 |

| | |

| |Peter G Blain , Organophosphorus poisoning (acute) . clinical evidence, Search date April 2010 |

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|8.0 |Signature of the candidate |

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|9.0 |Remarks of the Guide | |

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|10.0 |Guide |Dr Srinivasa Prabhu N C |

| | |Professor and HOD of Emergency Medicine |

| | |KIMS Hospital |

| | |Bangalore-04. |

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| |Signature | |

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|11.0 |Head of the Department |Dr Srinivasa Prabhu N C |

| | |Professor and HOD of Emergency Medicine |

| | |KIMS Hospital |

| | |Bangalore-04. |

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| |Signature | |

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|12.0 |Remarks of the Principal | |

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|13.0 |Principal | |

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| |Signature | |

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