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 |
| | | |
|02 |Name of institution |KEMPEGOWDA INSTITUTE |
| | |OF MEDICAL SCIENCES(KIMS) |
| | |K.R.ROAD, V.V.PURAM, |
| | |BANGALORE 560004. |
| | | |
|03 |Course of study and subject |M.D EMERGENCY MEDICINE |
| | | |
|04 |Date of admission to course |1/06/13 |
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| | |
|05 |Title of the Topic: |
| | |
| |“A Clinical Study of Intravenous Magnesium sulphate in the treatment |
| |of Acute Organophosphate poisoning”. |
| | |
|6.0 |Brief Resume of the intended work |
| | |
|6.1 | |
| |Need for the study: |
| | |
| | |
| |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 |
| | |
| |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. |
| | |
| | |
| | |
|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 |
| | |
|6.3 |Objectives of the study |
| | |
| | |
| |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 |
| | |
|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 |
| | |
| | |
| | |
| | |
| |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 | |
| | |
|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. |
| | |
| | |
| |References: |
|7.5 | |
| |Roberts Darren M, Aaron Cynthia K. Management of acute organophosphorus pesticide poisoning. BMJ 2007; 334:629-634. |
| | |
| |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 |
| | |
|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. |
| | | |
| |Signature | |
| | | |
| | | |
|11.0 |Head of the Department |Dr Srinivasa Prabhu N C |
| | |Professor and HOD of Emergency Medicine |
| | |KIMS Hospital |
| | |Bangalore-04. |
| | | |
| | | |
| |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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