Annexure – I



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

| 1. |Name of the candidate | DR. RAGHURAM A T S |

| |and address |S/O THYAGARAJU |

| |(in block letters) |#195 SUBBRAM CHETTY ROAD |

| | |BASAVANGUDI BANGALORE-560004 |

| |Name of the institution |VYDEHI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH HOSPITAL.WHITEFIELD, BANGALORE. |

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|3. |Course of study and subject |M.D. ANAESTHESIA |

|4. |Date of admission to course |5th JUNE, 2013 |

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|5. |Title of the Topic : |

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| |A COMPARITIVE STUDY OF EFFICACY OF DEXMEDETOMIDINE AND PROPOFOL FOR CONSCIOUS SEDATION IN REMOTE LOCATION. |

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|6. |Brief resume of the intended work: |

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| |6.1. Need for the study: |

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| |Anesthesiologists are frequently called to remote locations such as endoscopy rooms to give conscious sedation for patients undergoing endoscopic |

| |procedures. |

| |Commonly used drugs to give conscious sedation are Dexmedetomidine and Propofol. Dexmedetomidine has much higher affinity for alpha 2 adrenergic |

| |receptors. Dexmedetomidine possesses anxiolytic, sedative, sympatholytic and analgesic properties without respiratory depressant effect. The |

| |sympatholytic effect of dexmedetomidine decreases heart rate and mean arterial pressure by reducing noradrenaline release. In addition, dexmedetomidine|

| |has the ability to reduce both the anesthetic and opioid analgesic requirements during procedures . Propofol as sedative hypnotic produces rapid |

| |unconsciouness, and is ideal for such procedures as recovery period is rapid and patients can be discharged soon after the procedure. The disadvantages|

| |of using propofol is its lack of analgesia and hypotension. |

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| |6.2. Review of literature: |

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| |Search across journals, showed the following study reports in regard to this topic over the past few years. Some of the studies have been cited as |

| |follows: |

| |Dere K et al[7] in 2010 did a comparative study of dexmedetomidine versus midazolam for sedation , pain and hemodynamic control during , colonoscopy |

| |under conscious sedation. A total of 60 ASA I-II patients, between 20 and 80 years of age were included in the study. Patients were randomly assigned |

| |to two groups. Midazolam 0.05 mg kg(-1) and fentanyl citrate 1 microg kg(-1) were administered intravenously to cases in Group I (n = 30). An initial |

| |loading dose of 1 microg kg(-1) dexmedetomidine was administered intravenously in 10 min to cases in Group II (n = 30) before the procedure and as a |

| |continuous infusion dose of 0.5 microg kg(-1) h(-1) just before the procedure started. Also 1 microg kg(-1) fentanyl citrate was administered |

| |intravenously immediately before the procedure. Peripheral oxygen saturation (S(pO2)), mean arterial pressure (MAP), heart rate (HR), |

| |Ramsay Sedation Scale (RSS), Numeric Rating Scale (NRS) scores and colonoscopist satisfaction scores of the cases were recorded.The study inferred |

| |dexmedetomidine provides more efficient hemodynamic stability, higher Ramsay sedation scale scores, higher satisfaction scores and lower NRS scores in |

| |colonoscopies. According to our results we believe that dexmedetomidine can be used safely as a sedoanalgesic agent in colonoscopies. |

| |Kenan kaygusuz et al[5] in 2008 did a comparative study of sedation with dexmedetomidine or propofol during shock wave lithotripsy. Forty-six |

| |patients were randomly allocated into two groups to receive either dexmedetomidine or propofol for elective ESWL. Dexmedetomidine was infused at 6 |

| |microg kg(-1) h(-1) for 10 min followed by an infusion rate of 0.2microg kg(-1) h(-1). Propofol was infused at 6 mg kg(-1) h(-1) for 10 min followed|

| |by an infusion of 2.4 mg kg(-1) h(-1) Fentanyl 1 microg/kg IV was given to all patients 10 min before ESWL. Pain intensity was evaluated with a visual|

| |analog scale at 5-minintervals during ESWL (10–35 min). Sedation was determined using the Observer’s Assessment of Alertness/Sedation. The Observer’s |

| |Assessment of Alertness/Sedation scores and hemodynamic and respiratory variables were recorded regularly during ESWL (35 min) and up to 85 min |

| |after.Forty patients were evaluated. Visual analog scale values with dexmedetomidine were significantly lower than those with propofol only at the |

| |25–35 min assessments . During sedation, the respiratory rate with dexmedetomidine was significantly slower but Spo2 was significantly higher than with|

| |propofol. Other clinical variables were similar . They inferred combination of dexmedetomidine with fentanyl can be used safely and effectively for |

| |sedation and analgesia during ESWL. |

| |Y Demiraran et al[6] in 2007 did a comparison of dexmedetomidine and midazolam used for sedation of patients during upper endoscopy. The aim of the |

| |present prospective, randomized study was to investigate and compare the safety and efficacy of dexmedetomidine versus midazolam in providing sedation|

| |for gastroscopy. A total of 50 adult patients (25 patients receiving dexmedetomidine and 25 patients receiving midazolam), 18 to 60 years of age, and |

| |rated I and II on the American Society of Anesthesiologists physical status classification system were included. A brief questionnaire was used to |

| |collect demographic data; patients were asked to rate anxiety, satisfaction with care to date and expected discomfort on a visual analogue scale. The |

| |following parameters were measured continuously and recorded every minute: heart rate, mean arterial pressure, hemoglobin oxygen saturation and |

| |respiratory rate. Dexmedetomidine was found to be similar to midazolam with regard to gagging, patient satisfaction, patient discomfort, anxiety scores|

| |and recovery time; it was superior with regard to endoscopist satisfaction, retching and the total number of patients having any type of side effects. |

| |Dexmedetomidine, being safe and effective, seems to be a good alternative to midazolam for sedation of patients during upper endoscopy. |

| |J. H. Ryu et al[5] in 2012 did a study to compare the safety profiles and efficacies of |

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| |remifentanil and dexmedetomidne for sedation during flexible bronchoscopy. Seventy-two |

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| |patients undergoing elective flexible bronchoscopy were randomly assigned to a propofol- |

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| |remifentanil group ( Group PR n=36 ) and a propofol-dexmedetomidine group ( Group PD |

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| |n=36 ). The primary outcome was the incidence of oxygen desaturation. Haemodynamic |

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| |variables adverse events , need of oral cavity section, cough scores, satisfaction scores of |

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| |patients and bronchoscopists, level of sedation and recovery time were also compared. They |

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| |concluded that dexmedetomidine was associated with fewer incidents of oxygen desaturation |

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| |and a reduced need for oral cavity section than remifentanil during flexible bronchoscopy. |

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| |Anchalee Techanivat et al[3] in 2012 did a comparision of dexmedetomidine versus propofol |

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| |on hypo tension during colonoscopy under sedation. Sedation for colonoscopy with propofol is |

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| |often associated with decreasing in arterial blood pressure. Dexmedetomidine is a sedative drug |

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| |with selective alpha to adrenoreceptor agonist. The direct action of blood vessels causes |

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| |vasoconstriction and possible increase of blood pressure. This study evaluates |

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| |dexmedetomidine on supression of decrease in blood pressure compared with propofol for |

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| |sedation during colonoscopy. Seventy patients with ASA I-III were randomly allocated into two |

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| |groups to receive either dexmedetomidine or propofol for elective colonoscopy under sedation. |

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| |They concluded dexmedetomidine for sedation in colonoscopy reduced hypotension incidence |

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| |than propofol. |

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| |6.3. Objectives of study: |

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| |To compare the efficacy of dexmedetomidine to propofol for providing conscious sedation ,for procedures ,in remote location. |

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|7. |Materials and Methods: |

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| |7.1. Source of data: |

| |This study will be done on 60 patients coming for prolonged endoscopic procedures, lasting for 2-3 hrs, at Vydehi Institute of Medical Sciences & |

| |Research Center , Bangalore. |

| |7.2. Method of collection of data: |

| |1) Study design: |

| |Observational comparative study. |

| |2) Duration of study: |

| |It is a prospective study from January 2014 to August 2015. |

| |3) Sample size: |

| |A total of 60 ASA 1 and 2 patients, admitted to our Hospital posted for |

| |prolonged endoscopic procedures lasting at least 2-3 hrs will be included for the |

| |study. |

| |4)Iclusion criteria: |

| |Patients between age of 20- 60 yrs |

| |Patients in ASA grade 1 and 2 |

| |Patients willing to give informed consent. |

| |5) Exclusion criteria: |

| |ASA grade 3 and 4 |

| |Patients with known allergy to dexmedetomidine and propofol |

| |6) Methodology: |

| |A total of 60 ASA 1 and 2 patients, admitted to our Hospital posted for prolonged endoscopic procedures lasting at least 2-3 hrs will be included for |

| |the study. |

| |Patients will be randomly assigned to two groups. |

| |Group I (n = 30).  Dexmedetomidine will be administered as intravenous bolus 15 min before the procedure and continuous infusion will be started just |

| |before the procedure is started and continued till end. |

| |Group II (n = 30) Propofol will be administered as intravenous infusion before the procedure is started and continued till end. |

| |Peripheral oxygen saturation (S(pO2)), Mean arterial pressure(MAP), Heart rate (HR), Ramsay Sedation Scale (RSS) score of the cases will be recorded |

| |and assessed immediately after the procedure and repeated 4 hrs later. |

| |7) Statistics: |

| |Student’s t and χ2 tests will be used in comparision of quntitative and qulalitative values of two groups in the study. |

| |7.3. Does the study require any investigation or interventions to be conducted on patients or other humans or animals? If so, please describe briefly. |

| |No |

| |7.4. Has ethical clearance been obtained from your institution in case of 7.3? |

| |Yes- in accordance with the ethical committee. |

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|8. |List of references: |

| |Dere K, Sucullu I, Budak ET, Yeyen S, Filiz AI, Ozkan S, Dagli G. A comparison of dexmedetomidine versus midazolam for sedation, pain and hemodynamic |

| |control, during colonoscopy under conscious sedation. European Journal Anesthesiology. 2010 Jul;27(7):648-52. |

| |Kenan Kaygusuz, MD Gokhan Gokce, MD Sinan Gursoy, MD Semih Ayan, |

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| |MD Caner Mimaroglu, MD Yener Gultekin, MD. A comparision of sedation |

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| |with dexmedetomidine or propofol during shockwave lithotripsy: A randomized |

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| |controlled trial. Anesthesia Analgesia 2008;106:114 –9. |

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| |Yavuz Demiraran MD, Esin Korkut MD, Ali Tamer MD, Ilknur Yorulmaz MD, |

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| |Buket Kocaman MD, Gulbin Sezen MD, Yusuf Akcan MD. The comparison of |

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| |dexmedetomidine and midazolam used for sedation of patients during upper |

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| |endoscopy: A prospective, randomized study. Candian Journal |

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| |Gastroenterology 2007;21(1):25-29. |

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| |J. H. Ryu, S. W. Lee, J. H. Lee, E. H. Lee, S. H.Do and C. S. Kim. Randomized |

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| |double blind study of remifentanil and dexmedetomidine for flexible |

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| |bronchoscopy.British Journal of Anaesthesia 108 (3): 503–11 (2012). |

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| |Anchalee Techanivate, Tewarux Verawattaganon, Chuleeporn Saiyuenyong and |

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| |Pornpatra Areeruk. A comparison of dexmedetomidine versus propofol on |

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| |hypotension during colonoscopy under sedation. Journal Anaesthesia and |

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| |Clinical research 2012 ; 3:11. |

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| |Tae Dong Kweon. Sedation under JCI standard. Korean Journal of |

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| |Anaesthesiology 2011; 61(3): 190-194. |

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| |Chainaki IG, Manolaraki MM, Paspatis GA. Deep sedation for endoscopic |

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| |retrograde cholangiopancreatography. World Journal of Gastrointestinal |

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| |Endoscopy 2011; 3(2): 34-39. |

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|9. |Signature of Candidate | |

| 10. | |

| |Remarks of the Guide: |

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| |Conscious sedation in remote location require patients to be quiet and amenable to endoscopic |

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| |procedures , which may occasionally be painful. |

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| |Propofol does not provide necessary analgesia. Dexmedetomidine possesses anxiolytic, sedative, |

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| |sympatholytic and analgesic properties and early recovery on stopping infusion. This study is recommended |

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| |to assess the advantages and disadvantages of Dexmedetomidine and propofol for giving conscious |

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| |sedation. |

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|11. |

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|Name & Designation of : |

|(in block letters) |

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|11.1 Guide: |

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|DR SADANAND GOPAL. MD |

|PROFESSOR AND HEAD OF THE DEPARTMENT ANAESTHESIA |

|VYDEHI INSTITUE OF MEDICAL SCIENCES AND |

|RESEARCH CENTER,WHITEFIELD BANGALORE |

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|11.2 Signature |

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|11.5 Head of Department |

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|DR SADANAND GOPAL. MD |

|PROFESSOR AND HEAD OF THE DEPARTMENT |

|ANAESTHESIA |

|VYDEHI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTER,WHITEFIELD BANGLORE |

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|11.6 Signature |

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|12. |

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|12.1 Remarks of the Chairman/Principal |

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|12.2 Signature |

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