Rajiv Gandhi University of Health Sciences



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

| |NAME OF THE CANDIDATE |DR.DINAKAR K.R, |

| |AND ADDRESS |POST GRADUATE STUDENT, |

| | |J.J.M. MEDICAL COLLEGE, |

| | |DAVANGERE-577004 |

| | |KARNATAKA. |

| |NAME OF THE INSTITUTION |J.J.M.MEDICAL COLLEGE, |

| | |DAVANGERE-577004. |

| |COURSE OF STUDY & SUBJECT |MEDICAL |

| | |M.D.PHARMACOLOGY. |

| |DATE OF ADMISSION TO COURSE |18th MAY 2012 |

| |TITLE OF TOPIC |COMPARATIVE STUDY OF VARIATIONS IN BLOOD PRESSURE AND HEART RATE |

| | |AMONG NORMOTENSIVE PATIENTS AND HYPERTENSIVE PATIENTS RECEIVING |

| | |ANGIOTENSIN RECEPTOR BLOCKERS DURING SURGERY UNDER SPINAL ANESTHESIA.|

| |BRIEF RESUME OF THE INTENDED WORK: |

| |Need for the study: |

| |Spinal anesthesia has been a boon for surgery for a long time now. Post-surgical complications pertaining to the use of anesthetics has |

| |considerably reduced as the systemic absorption of the drug is predictable and its effects manageable. So spinal anesthesia is almost |

| |always preferred whenever the surgical field is the lower abdomen, perineum or the lower limbs. |

| |The most common complication of spinal anesthesia during surgery is hypotension. Though it is seen in almost all the patients, there |

| |appears to be a relatively higher incidence in hypertensive patients sometimes causing hemodynamic compromise[1]. So the need for |

| |pressor agents and other interventions is more common in these patients. Though these effects are reduced to a certain extent by the |

| |anti-hypertensive medications, their varying effects on the cardiovascular system can cause some unwanted effects during the procedure |

| |[2]. If the anesthetist can predict these effects then the necessary precautions taken, might reduce the post-anesthetic morbidity and |

| |mortality. |

| |A dilemma always existed as to which anti-hypertensive agent has to be stopped before the surgery and which can be continued |

| |peri-operatively. Patients with well-controlled hypertension should normally continue their medication up to, and including, the day of |

| |surgery [2]. There are conflicting reports on the need to continue Angiotensin Convertase Inhibitor on the day of surgery [3,4]. Studies|

| |have also been done to determine the effects of Calcium Channel blockers and Beta Blockers in patients undergoing general |

| |anesthesia[5,6] and spinal anesthesia[7].So this is an effort to study the various effects of Angiotensin receptor blockers during |

| |surgery under spinal anesthesia on blood pressure and heart rate. |

| |Review of literature: |

| |Bernd Hartmann and colleagues studied the incidence and risk factors for hypotension after spinal anesthesia in 2002. In their |

| |multivariate analysis, independent factors for relevant hypotension after spinal anesthesia consisted of 3 patient related variables; |

| |chronic alcohol consumption, history of hypertension, body mass index, height of sensory block and urgency of surgery. They concluded |

| |that with increase in each risk factor the incidence of hypotension increased 3-4 fold[1]. |

| |J.M.Saddler, in his article Update in Anesthesia, mentions that an elective surgery has to be postponed if the patient’s blood pressure|

| |is not under control and also mentions that patients with well controlled hypertension should continue to take the medication even on |

| |the day of surgery[2]. |

| |Cozanitis, in 2004, reported a case where a patient who was on Enalapril underwent Hip replacement surgeries of both limbs but with an |

| |interval of 3 years between the two surgeries. He observed that when the patient took the medication on the day of surgery, there was |

| |profound hypotension following spinal anesthesia and concluded that Angiotensin Convertase Inhibitors must be withdrawn before |

| |surgery[3]. |

| |C. Hohn and colleagues studied the effect of Angiotensin Convertase Inhibitors on blood pressure changes in the early phase of spinal |

| |anesthesia and concluded that long term treatment with Angiotensin Convertase Inhibitors does not further exaggerate drop in the blood |

| |pressure [4]. |

| |Coriat P et al did a study to determine if the Angiotensin Convertase Inhibitor therapy until the morning of the surgery under general |

| |anesthesia had any effect on blood pressure during the surgery. They concluded that patients chronically treated with Angiotensin |

| |Convertase Inhibitors and continuing the drug on the day of surgery may increase the probability of hypotension at induction[8][11]. |

| |Thomas Comfere et al concluded from their study that it is better to discontinue the Angiotensin Convertase Inhibitor/Angiotensin |

| |Receptor Blockers at least ten hours before the surgery as it increases the incidence of hypotension[9][10]. |

| |Objectives of study: |

| |To study the variations of blood pressure and heart rate during spinal anesthesia in patients on anti-hypertensive medications that act |

| |by blocking angiotensin receptors and to compare the results with the data obtained with normotensive patients undergoing surgery. |

| |METHODOLOGY: |

| |7.1. Source of data: This clinical study will be conducted in patients undergoing elective surgeries under spinal anesthesia at Bapuji |

| |and Chigateri Government Hospital, Davangere. Hypertensive patients in these institutes receive the anti-hypertensive medication on the |

| |day of surgery. |

| | |

| |7.2. Subjects : |

| |A. Inclusion criteria: |

| |Patients undergoing elective surgeries under Spinal anesthesia who: |

| |Are above thirty and below sixty five years. |

| |Are diagnosed cases of essential hypertension and are started on Angiotensin receptor antagonists at least 1 week prior to surgery. |

| |The patients who have taken the drug on the day of surgery. |

| |B. Exclusion criteria: |

| |1. Patients on concomitant medications which are likely to affect blood pressure and heart rate during the surgery. |

| |2. Patients with other co-existing diseases like coronary artery disease or other cardiac diseases, severe hypovolemia, sepsis. |

| |3. Pregnancy. |

| | |

| |7.3. Study Design : Observational Study. |

| |7.4. Duration of study : 20 months. |

| |7.5. Procedure: |

| |A total of 60 patients will be included in this study. They will be divided into 2 groups of 30 patients each [n=30]. The first group is|

| |the normotensive individuals undergoing elective surgeries under spinal anesthesia. The second group is the hypertensive individuals |

| |taking the drug under study for at least one week prior to the elective surgery under spinal anesthesia. |

| |The patients eligible for the study will be assessed with the following parameters during the entire period of the surgery after they |

| |are anesthetized at spinal level: |

| |a) The fluctuations in the blood pressure (a drop of 20% systolic blood pressure(SAP) will be considered as hypotension necessitating |

| |rescue medication). |

| |b) The variations in the heart rate ( 25% baseline heart rate will be considered |

| |tachycardia), pulse pressure and mean blood pressure. |

| |c) The requirement of any pressor agents or any other means to hemodynamically stabilize the patient. |

| | |

| |Statistical Analysis: |

| |The recordings of the subjects will be compared against the recordings of the normotensive individuals using suitable statistical |

| |analysis. |

| |1. Intra group comparison will be done by the paired‘t’ test. |

| |2. Intergroup comparison will be done by unpaired‘t’ test. |

| | |

| |7.6. Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, describe|

| |briefly? |

| |NO. This is an observational study. No interventions will be made during the surgical procedure. |

| | |

| |7.7. Has ethical clearance been obtained from your institution in case of 7.6? |

| |YES |

| |EXPECTED OUTCOME AND ITS USEFULNESS: |

| |The study, on completion, is expected to provide information on the variations in heart rate and blood pressure in hypertensive patients|

| |on Angiotensin Receptor Blockers during surgery under spinal anesthesia. Data obtained will suggest the anesthetist to anticipate |

| |possible adverse effects and take measures to avert them. |

| |LIST OF REFERENCES: |

| |1) Bernd Hartmann, Alex Junger, Joachim Klasen, Matthias Benson, Andreas Jost, Anne Banzhaf et al. The incidence and risk factors for |

| |hypotension after spinal anesthesia induction: an analysis with automated data collection. Anesth Analg 2002; 94:1521-9. |

| |2) JM Saddler, Royal Devon and Exeter Hospital, UK: Anesthesia and hypertension- Update in Anesthesia, Issue 2(1992) Article 3. |

| |3) Cozanitis DA. The importance of inhibiting Angiotensin Convertase Inhibitor treatment before spinal anesthesia-a controlled case |

| |report. Anesthesiol Reanim.2004;29(1):16-8 |

| |4) C. Hohne, L. Meier, W. Boemke, G. Kaczmarczyk. Angiotensin Convertase Inhibitor Inhibitors do not exaggerate the blood pressure |

| |decrease in the early phase of spinal anesthesia. Acta Anesthesiologica Scandinavica. 2003;47(7):891-6 |

| |5) JW Sear, C. Jewkes, JC Tellez, P Foex. Does the choice of antihypertensive therapy influence hemodynamic responses to induction, |

| |laryngoscopy and intubation. British Journal of Anesthesia.1994; 73:303-8. |

| |6) Samad K, Khan. F, Azam I. Hemodynamic effects of anesthetic induction in patients treated on beta and calcium channel blockers. |

| |Middle East J Anesthesiol.2008; 19(5):1111-28. |

| |7) Padmanabha Kaimar, Narendranath Sanji, Madhusudhana Upadya, K Riaz Mohammed. A comparison of hypotension and bradycardia following |

| |spinal anesthesia in patients on calcium channel blockers and β-blockers.2012;44(2):193-196. |

| |8) Coriat P, Richer C, Douraki T, Gomez C, Hendricks K, Guidicelli JF, et al. Influence of chronic Angiotensin inhibition on anesthetic |

| |induction. Anesthesiology. 1994 Aug;81(2):299-307. |

| |9) Thomas Comfere, MD, Juraj Sprung, MD, PhD, Matthew M. Kumar, MD, |

| |Myongsu Draper, BSN, Diana P. Wilson, BSN, Brent A. Williams, MS, |

| |David R. Danielson, MD, Lavonne Liedl, RRT, and David O. Warner, MD. Angiotensin system inhibitors in a general surgical population. |

| |Anesth Analg 2005;100: 636 –44. |

| |10) Brabant SM, Bertrand M, Eyraud D, Darmon PL, Coriat P. The hemodynamic effects of anesthetic induction in vascular surgical patients|

| |chronically treated with angiotensin II receptor antagonists. Anesth Analg. 1999 Dec; 89(6):1388-92. |

| |11) Ronald D. Miller, Lars I. Erikkson, Lee. A. Fleisher, Jeanine. P. Weiner-Kronish, William. L. Young. Miller’s Anesthesia. 7th |

| |Edition: Philadelphia (PA); Churchill Livingstone Elsevier. 2010. p. 1094-1095. |

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|10. |Signature of the Candidate | |

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|11. |Remarks of the Guide |Data obtained will help the anesthetist to avert possible hypotension due to |

| | |Angiotensin receptor blockers during surgery under spinal anesthesia. |

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|12. |Name & Designation of the | |

| |(in block letters) | |

| |12.1 Guide | |

| | |DR. NARENDRANATH.S. |

| | |ASSOCIATE PROFESSOR, |

| | |DEPARTMENT OF PHARMACOLOGY, |

| | |J.J.M. MEDICAL COLLEGE, |

| | |DAVANGERE-577004 |

| |12.2 Signature | |

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| |12.3 Co-Guide | |

| | |DR. RAVISHANKAR.R.B, |

| | |PROFESSOR, |

| | |DEPARTMENT OF ANESTHESIA, |

| |12.4 Signature |J.J.M.MEDICAL COLLEGE, |

| | |DAVANGERE-577004 |

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| |12.5 Head of the Department | |

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| | |DR. SOMASHEKHAR .H.S |

| | |PROFESSOR AND HEAD, |

| |12.6 Signature |DEPARTMENT OF PHARMACOLOGY, |

| | |J.J.M.MEDICAL COLLEGE, |

| | |DAVANGERE-577004 |

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|13. |13.1 Remarks of the Chairman & |DR. MANJUNATH ALUR, |

| |Principal |PRINCIPAL, |

| | |J.J.M. MEDICAL COLLEGE, |

| | |DAVANGERE-577004. |

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| |13.2 Signature | |

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