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From, Dr. Devaraju.M.R. Post Graduate in Department of Physiology, A. J. Institute of Medical Sciences, Mangalore- 575004 To, The Registrar, Rajiv Gandhi University of Health Sciences, Bangalore (Through proper channel) Sub: Submission of Synopsis of Dissertation Respected Sir, Herewith, I am submitting synopsis of my dissertation work: “A COMPARATIVE STUDY OF ORTHOSTATIC HYPOTENSION AFTER WHOLE BLOOD DONATION WITH VARIOUS PHYSIOLOGIC STRATEGIES TO PREVENT FAINTING RESPONSES” for the registration in Rajiv Gandhi University of Health Sciences, Bangalore. Kindly accept the same and oblige. Thanking you, Yours faithfully, (Dr. Devaraju. M. R) Place: Mangalore Date: 28-10-2011 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE,KARNATAKA. ANNEXURE II SYNOPSIS FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1 NAME OF THE CANDIDATE AND ADDRESS DR. DEVARAJU.M.R. POSTGRADUATE STUDENT DEPT OF PHYSIOLOGY A.J.INSTITUTE OF MEDICAL SCIENCES MANGALORE- 575004 2 NAME OF THE INSTITUTION A.J.INSTITUTE OF MEDICAL SCIENCES MANGALORE- 575004 3 COURSE OF STUDY AND MD COURSE IN PHYSIOLOGY SUBJECT 4 DATE OF ADMISSION 23rd APRIL 2011 TOCOURSE 5 TITLE OF THE TOPIC A COMPARATIVE STUDY OF ORTHOSTATIC HYPOTENSION AFTER WHOLE BLOOD DONATION WITH VARIOUS PHYSIOLOGIC STRATEGIES TO PREVENT FAINTING RESPONSES 6 BRIEF RESUME OF INTENDED WORK 6.1. NEED FOR THE STUDY Donating blood is a generous life-saving gift. It is important to take care of blood donors as health care aspect. Vasovagal reactions occur in 2-5% blood donations.1Syncope occasionally leads to injury. Prevention of vasovagal reaction in blood donations is thereby an important issue. The amount of blood removed during a whole blood donation is 500ml and 40-50ml for testing (540ml).2Is about the same as the amount of blood pooled downward rapidly during stand up from a supine position (300-800ml).3 This causes fainting and orthostatic intolerance. In India amount of whole blood donation is 350ml.4 The physiologic mechanisms are direct effects of removal of 540ml of whole blood, the psychological stress of instrumentation and giving blood (i.e., fear of needles, pain, and the sight of blood), and the orthostatic effects superimposed on a hypovolemic state after the donation.5 Lower body muscle tensing, plasma volume expansion, and water drinking have been applied as physiologic strategies to prevent syncope in patients with orthostatic intolerance,6 but it is not well known how these strategies should be applied or combined before, during, and after whole blood donation.5 Hence this study may become reference base for the protocol . 6.2. REVIEW OF LITERATURE A Study was done on 31 patients presenting with episodes of unexplained syncope. 20 patients were double blind placebo controlled and an open study in 11of giving 120mmol/day of sodium chloride. After 8 weeks of treatment,15(70%) of the 21patients given salt and 3(30%) of the placebo group showed increases in plasma and blood volume and in orthostatic intolerance, and decreases in baroreceptor sensitivity.7 21 patients with recurrent syncope were instructed to perform leg crossing and muscle tensing for at least 30 seconds at the onset of a tilt table-provoked impending faint. Continuously measured blood pressure and heart rate at nadir and during the maneuver were compared. Ten months after the test, the physical counter-maneuver performed in 20 of 21 subjects, showed increase systolic and diastolic blood pressure and heart rate. During the maneuver, prodromal symptoms disappeared in all patients and none lost consciousness.8 Study was done on 88 patients presenting to the syncope unit, leg crossing and skeletal muscle tensing during free standing was advised.54 performed skeletal muscle tensing in the leg crossed position. The principal findings were as follows. 1) Leg crossing produces a rise in cardiac output, blood pressure and pulse pressure in patients prone to vasovagal syncope, total peripheral resistance decreased slightly. 2)Skeletal muscle tensing during leg crossing further increases cardiac output, with additional rise in blood pressure and a drop in total peripheral resistance.9 Water loading significantly reduced reactions relative to no water control group confirmed in a study of nearly 9000 high school donors who ingested either no water or 473ml of water approximately 0 to 30min before whole blood donation.10 6.3. AIMS & OBJECTIVES OF STUDY 1. To measure orthostatic blood pressure before and after whole blood donation. 2. To compare orthostatic hypotension immediately and at 5min, 10min and 15min after whole blood donation. 3. To compare orthostatic hypotension without and with various physiologic strategies to prevent fainting responses during or after whole blood donation. . 7 MATERIALS AND METHODS 7.1. SOURCE OF DATA 1. Type of study: comparative study. 2. Site of study : A J Institute of Medical Science, Mangalore 3. Source of data: Healthy volunteers in blood bank and blood donation camps, Mangalore. 4. Sample size:120 5. Sampling technique: Random sampling technique. 6. Inclusion criteria: Normal healthy voluntary blood donors, 18-40yrs of age group, both males and females. 7. Exclusion criteria: History of Hypertension, Diabetic mellitus, Orthostatic hypotension, Irregular menstruation, Drug intake causing orthostatic hypotension. 7.2. METHOD OF COLLECTION OF DATA Hundred and twenty healthy volunteers of blood donation camp and blood bank will be selected for study. Subjects with history of hypertension, diabetic mellitus, pregnancy, blood loss, orthostatic hypotension, menstrual irregularities will be excluded. Written informed consent with relevant data (name, age, sex) will be taken. Pulse and orthostatic blood pressure will be measured 30 min before blood donation, immediately and at 5min, 10min and 15min after blood donation. Subjects will be divided into four groups (30 each say A, B, C and D). Group A: Controls. Physiologic strategies will not be applied to prevent fainting responses. Group B: Salt and water will be advised. Salt 1.2gm will be measured and dissolved in 500ml bottled water. It will be given 30min before blood donation. Group C: Lower body muscle tension will be advised. (leg crossing, leg and abdominal muscle tensing, buttock clenching). Lower body muscle tension will be advised for duration of 5 to 10 seconds and a frequency of 3 times per minute during first part of phlebotomy (first one third duration of blood donation, first 3min). It will be advised again when the bag is nearly full, the tubing is clamped and needle is removed. Group D: Both physiologic strategies of B and C will be applied. Procedure of orthostatic blood pressure measurement. Radial pulse is counted for one minute. Blood pressure will be recorded using spygmomanometer in supine position after at least 5min of complete bed rest and then after standing within 3min. subjects with fall in blood pressure hypotension. Statistical Analysis: By using one way ANOVA. >20/10 mm of Hg will be considered as orthostatic 7.3 Does the study require any investigation or interventions to be conducted on patients or other human or animals? If so, please describe briefly. Yes, Blood pressure measurements. 7.4 Has the ethical clearance obtained from your institution? YES 8 LIST OF REFERENCES 1) Sulochana PV, Mettinamma R, Mathai J, Sathyabhama S. Suspected acute myocardial infarction- An unusual reaction in a blood donor. Transfusion bulletin 2004;12(2):08. 2) Tomasulo P, Bravo M, Kamel H. Time course of vasovagal syncope with whole blood donation.ISBTSciser 2010;5:52-8. 3) Smith AA, Halliwill JR, Low PA, Wieling W. Pathophysiological basis of orthostatic hypotension in autonomic failure. JPhysiol 1999;519(Pt 1):1-10. 4) Blood donation[updated on16 Aug 2011]. Available from http://en.wikipedia.org/wiki/Blood_donation[Acessed on 7sep 2011]. 5) Wieling W, France CR, van Dijk N, Kamel H, Thijis RD, Tomasulo P. Physiologic strategies to prevent fainting responses during or after whole blood donation. Transfusion [Internet].2011Jun3[Cited 2011 Sep13];Available from:http://www.ncib.nlm.nih.gov/pubmed/21645008. 6) Wieling W, Colman N, Krediet CT, Freeman R. Non pharmacological treatment of reflex syncope. ClinAuton Res 2004;14Suppl 1:62-70. 7) El-Sayed H, Hainsworth R. Salt supplementation increases plasma volume and orthostatic tolerance in patients with unexplained syncope. Heart 1996;75:134-40. 8) Krediet CT, van Dijk N, Linzer M, van Lieshout JJ, Wieling W. Management of vasovagal syncope: controlling or aborting faints by leg crossing and muscle tensing. Circulation 2002;106:1684-9. 9) Van Dijk N, de Bruin IG, Gisolf J, Bruin-Bon HA, Linzer M, van Lieshout JJ, Wieling W. Hemodynamic effects of leg crossing and skeletal muscle tensing during free standing in patients with vasovagal syncope. J ApplPhysiol 2005;98:584-90. 10) Newman B, Tommolino E, Andreozzi C,Joychan S, Pocedic J, Heringhausen J. The effect of a 473-ml (16-oz) water drink on vasovagal donor reaction rates in high-school students. Transfusion 2007;47:1524-33. 9 SIGNATURE OF CANDIDATE 10 REMARKS OF THE GUIDE RECOMMENDED AND FORWARDED. 11 NAME AND DESIGNATION OF 11.1.GUIDE DR. SHIRAHATTI DAS KRISHNA PROFESSOR& HEAD DEPARTMENT OF PHYSIOLOGY A.J.INSTITUTE OF MEDICAL SCIENCES KUNTIKANA, MANGALORE - 575004 11.2. SIGNATURE 11.3. CO-GUIDE 11.4. SIGNATURE 11.5. HEAD OF THE OF THE DEPARTMENT 11.6. SIGNATURE DR. SHIRAHATTI DAS KRISHNA. 12 12.1.REMARKS OF THE CHAIRMAN AND PRINCIPAL 12.2.SIGNATURE OF THE PRINCIPAL