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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

|1. |Name of the candidate |Dr. RANGANATHA H K |

| |and address (in block | |

| |letters) |S/O KUBERAPPA H D(RTD TEACHER) |

| | |143, POST OFFICE ROAD. |

| | |MALLADIHALLI (POST) |

| | |HOLALKERE(TQ) |

| | |CHITRADURGA(DIST)-577531 |

|2. |Name of the Institution |J.J.M. MEDICAL COLLEGE, |

| | |DAVANAGERE |

| | |KARNATAKA |

| | |PIN - 577004. |

|3. |Course of the study and subject |POST-GRADUATE (MEDICAL) |

| | |M.D. IN ANAESTHESIOLOGY |

|4. |Date of admission to course |01/06/2012 |

|5. |Title of the topic |“COMPARISON BETWEEN DEXMEDETOMIDINE AND PROPOFOL FOR SHORT-TERM |

| | |SEDATION OF POSTOPERATIVE MECHANICALLY VENTILATED PATIENTS” |

|6. |BRIEF RESUME OF THE INTENDED WORK |

| |6.1 NEED FOR THE STUDY : |

| |One of the key factors in good patients care is appropriate analgesia and sedation to ensure patient comfort. This is of|

| |particular importance in the Intensive care unit(ICU). Intubated mechanically ventilated patients in the surgical ICU |

| |require sedation to tolerate the tracheal tube and the ventilator, to suppress cough and prevent respiratory fighting |

| |during intensive care procedures such as bronchial suction, physiotherapy and catheter placement1. |

| |The sedatives used most often include propofol, midazolam and lorazepam. All 3 of these medications provide adequate |

| |sedation but also can cause oversedation, that can lead to prolonged duration of mechanical ventilation, longer ICU and |

| |Hospital stays, increased incidence of ventilator-associated pneumonia and inability of patients to communicate with |

| |health care providers or family members2. |

| |Now newer drugs are being used for sedation in mechanically ventilated postoperative patients which have benefits over |

| |the conventionally used drugs. |

| |Dexmedetomidine is an alpha 2 adrenoreceptor agonist with a unique mechanism of action, providing sedation and |

| |anxiolysis via receptors within the locus ceruleus. Analgesia via receptors in the spinal cord, and attenuation of the |

| |stress response with no significant respiratory depression. In addition to sedation, dexmedetomidine provides analgesic |

| |effects, lack of respiratory depression, sympatholytic blunting of the stress response, preservation of neutrophil |

| |function(compared with the neutrophil suppressing effect of GABA agonist medications) and may establish more natural |

| |sleep-like state3. |

| |Propofol is selected as the comparator medication owing to its frequent use for short term sedation and is often |

| |identified as the sedative most commonly used in ICU. |

| |The present study is being undertaken in a randomized single blinded manner to evaluate sedative and analgesic |

| |properties, safety profile, cardiovascular responses, ventilation and extubation characteristics with dexmedetomidine |

| |compared to propofol in postoperative mechanically ventilated patients. |

| | |

| | |

| | |

| |6.2 REVIEW OF LITERATURE : |

| |In a randomized clinical study conducted on 60 adult patients who were expected to require a minimum of 6 hours |

| |postoperative short term ventilation and sedation, were allocated randomly, to receive IV infusion of either |

| |dexmedetomidine 0.2-0.5mcg/kg/hr or propofol 0.5-1mg/kg/hr and all patients received short acting fentanyl infusion |

| |0.25-0.5mcg/kg/hr to achieve desired sedation and analgesia. They concluded that dexmedetomidine and propofol are safe |

| |sedative drugs for postoperative mechanically ventilated patients and patients were easily aroused to co-operate for |

| |procedures with less fentanyl analgesia in dexmedetomidine group1. |

| |In a prospective randomized clinical study conducted on 20 patients expected to require a minimum of 8 hours artificial |

| |ventilation after surgery were randomized to receive sedation with either dexmedetomidine or propofol infusion, they |

| |concluded that patients sedated with dexmedetomidine could be easily aroused to cooperate with procedures4. |

| |In a single center, descriptive study of clinical practice at a 20-bed cardiac surgery ICU in a tertiary academic |

| |medical center, adult mechanically ventilated postcardiac surgery patients were received either dexmedetomidine or |

| |propofol for sedation therapy. The study concluded that no differences in the ICU length of stay and duration of |

| |mechanical ventilation in both the groups5. |

| |In a randomized study in Twenty-five centers in United States and Canada with 295 adults undergoing CABG surgery, it was|

| |concluded that Dexmedetomidine provided safe and effective sedation for post-CABG surgical patients and significantly |

| |reduced the use of analgesics6. |

| |In a prospective, randomized single-blinded trial with postoperative open heart surgery patients in the ICU  , it was |

| |concluded that Dexmedetomidine is comparable to propofol in the provision of sedation, and its effect on hemodynamic and|

| |respiratory parameters7.  |

| | |

| |6.3 OBJECTIVES OF STUDY : |

| |The comparative study of dexmedetomidine and propofol for sedation in postoperative mechanically ventilated patients has|

| |following objectives. |

| |To evaluate |

| |onset of sedation |

| |duration and level of sedation |

| |hemodynamic parameters(HR, BP, SpO2) |

| |number of add on sedatives in post operative patients |

|7. |MATERIALS AND METHODS : |

| |7.1 SOURCE OF DATA : |

| |The study will be conducted on 60 patients aged 18 years or older who are postoperative mechanically ventilated in ICUs |

| |of Bapuji Hospital and Chigateri General Hospital attached to JJM medical college Davanagere. |

| |7.2 METHODS FOR COLLECTION OF DATA : |

| |60 postoperative patients admitted in the ICU will be selected randomly after taking informed written consent from the |

| |relatives. |

| |Patients will be randomly allocated into 2 groups |

| |Group D-Dexmedetomidine Group will receive a Loading dose-2.5mcg/kg |

| |And a maintenance dose-0.5mcg/kg/hr |

| |Group P-Propofol Group will receive a Loading dose-1mg/kg |

| |and a Maintenance dose-0.5mg/kg/hr |

| | |

| | |

| | |

| |Inclusion Criteria |

| |Patients aged 18 years and above |

| |Post operative mechanically ventilated patients who require atleast 6hrs artificial ventilation after major abdominal or|

| |pelvic surgery. |

| | |

| |Exclusion Criteria |

| |Neurological procedures |

| |Known allergy to propofol or dexmedetomidine |

| |Known or suspected pregnancy |

| |Gross obesity ( over 50% above ideal body weight) |

| |Severe hepatic or renal disease |

| |Spinal or epidural anaesthesia |

| |History of corticosteroid therapy within the last 3 months |

| |Uncontrolled diabetes |

| |Procedure: |

| |A prospective, randomised, double blinded study will be undertaken. 60 post operative mechanically ventilated patients |

| |after major abdominal or pelvic surgery who require atleast 6 hr artificial ventilation admitted in the ICU will be |

| |selected randomly after taking written consent from their relatives. Patients will be randomly allocated into 2 groups. |

| |Group D - Dexmedetomidine group will receive a loading dose- 2.5mcg/kg and a Maintenance dose- 0.5mcg/kg/hr |

| |Group P - Propofol group will receive a loading dose- 1mg/kg and a Maintenance dose- 0.5mg/kg/hr |

| |IV line secured and patients will be connected to monitor to record pulse, NIBP, ECG and SpO2. Each patient will receive|

| |study drug after admission to ICU. Anaesthetic technique prior to entry into the ICU will be 5 mg / kg thiopental |

| |sodium, 3-4 mcg/kg fentanyl and vecuronium 0.05 mg/kg. After endotracheal intubation, maintenance of anaesthesia will |

| |be provided by halothane, N2O in O2. Additional vecuronium will be administered as required. At the end of the surgical|

| |procedure, neuromuscular blockade will not be reversed and artificial ventilation will be continued. On arrival to the |

| |ICU, patients will be immediately artificially ventilated with synchronized intermittent artificial ventilation (SIMV) |

| |with pressure support mode. Sedatives used before study enrollment will be discontinued prior to the initiation of the |

| |study drug. |

| |Optional blinded loading doses(upto 2.5mcg/kg dexmedetomidine or 1mg/kg propofol) will be administered at the |

| |investigator’s discretion. The starting maintenance infusion dose of blinded study drug will be 0.5mcg/kg/hr for |

| |dexmedetomidine and 0.5mg/kg/hr for propofol corresponding to the midpoint of the allowable infusion dose range. |

| |Dosing of study dose will be adjusted by managing clinical team based on sedation assessment performed with the Ramsey |

| |Sedation Score (RSS) a minimum of every 1 hour. Analgesia with fentanyl bolus doses(0.5-1mcg/kg) could be administered |

| |as needed every 15 minutes. No other sedatives or analgesics or muscle relaxants will be allowed during the double blind|

| |period. Study drug infusion will be stopped at the time of extubation in both the groups, after a maximum of 24hours or |

| |if the investigator felt it will be in the best interest of the patient. |

| |Assessment: |

| |A daily arousal assessment will be performed throughout the treatment period using RSS as follows: |

| |Score |

| |Response |

| | |

| |1 |

| |Anxious Or Restless or Both |

| | |

| |2 |

| |Coperative, Oriented and Tranquil |

| | |

| |3 |

| |Responds to Commands |

| | |

| |4 |

| |Brisk Response to Stimulus |

| | |

| |5 |

| |Sluggish Response to Stimulus |

| | |

| |6 |

| |No Response to Stimulus |

| | |

| | |

| |Safety will be assessed by monitoring laboratory test results, vital signs, ECG findings, physical examination findings,|

| |withdrawal related events and adverse events. |

| |Quantitative data will be analysed by student ‘t’ test and qualitative data will be analysed by chi square test. |

| |7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? |

| |If so, please describe briefly. |

| |Yes, on Patients. |

| |Investigations: |

| |Urine : |

| |albumin, sugar, microscopy |

| |Blood: |

| |Haemoglobin %, Total Count , Differential count. |

| |Random Blood Sugar (RBS), Blood Urea, Serum creatinine |

| |ECG |

| |HIV and HBsAg |

| |Chest X Ray |

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

| |Yes, |

| |Approval from the ethical committee of J.J.M Medical College, Davangere has been taken. Side effects of the drugs will |

| |be clearly explained to the patients in the local language and consent will be taken. |

| | |

|8. |LIST OF REFERENCES: |

| |Samia Elbaradie, Faten H El Mahalawy and Amira H Solyman. Dept of Anesthesia, ICU and Pain Relief and Clinical Pathology, |

| |National cancer Institute, Cairo University, Dexmedetomidine vs Propofol for short term sedation of postoperative mechanically|

| |ventilated patients. Journal of Egyptian Nat Cancer Inst., Vol 16, No.3, September:153-158,2004. |

| |Jenni Short. Use of Dexmedetomidine for Primary Sedation in a General Intensive Care Unit. Doi:10.1001/ccn2009920.. |

| |Richard R. Riker, Yahya Shehabi, Paula M. Bokesch. Dexmedetomidine vs Midazolam for sedation of Critically ill Patients: A |

| |Randomised Trial. JAMA 2009; 301(5): 489-499 (doi:10.1001/jama.2009.56) |

| |R.M.Venn and R.M.Grounds. Comparison between dexmedetomidine and propofol for sedation in the intensive care unit: patient and|

| |clinician perceptions, British Journal of Anaesthesia87(5): 684-90(2001). |

| |Anger K E, Szumita P m, Barolette S A, Labreche MJ, Fanikos J. Evaluation of dexmeditomidine vs propofol based sedation |

| |therapy in mechanically ventilated cardiac surgery patients at a tertiary academic medical centre. Critical Pathways in |

| |cardiology, 2010 Dec;9(4):221-6. |

| |Herr D L, Sum-Ping S T, England M. ICU Sedation after coronary artery bypass graft surgery Dexmedetomidine based versus |

| |Propofol based sedation regimens. J Cardiothorac Vasc Anesth 2003 Oct,17(5):576-84. |

| |Azrina Md Ralib ,  Saedah Ali , Mohd Nikman Ahmad , Ziyadi Mohd Ghazali, Nik Abdullah Nik Mohamad . A Comparative Study of |

| |Dexmedetomidine and Propofol for Sedation in The Cardiothoracic Intensive Care Unit. Int. Med J Vol. 6 No 2 December 2007. |

|9. |SIGNATURE OF THE CANDIDATE | |

|10. |REMARKS OF THE GUIDE |A newer drug like dexmedetomidine is a highly selective alpha 2 |

| | |agonist having properties of sedation, analgesia, anxiolysis and |

| | |antiemesis. Study of these properties would be more proper in aspects|

| | |of sedation and analgesia in ICU setup. |

|11. |NAME & DESIGNATION |DR. RAVI R MD.DA. |

| |11.1 GUIDE |Professor, |

| | |Department Of Anaesthesiology, |

| | |J.J.M Medical College, |

| | |Davanagere- 577004 |

| |11.2 SIGNATURE | |

| | | |

| |11.3 CO-GUIDE (If any) |- |

| | | |

| | | |

| |11.4 SIGNATURE |- |

| |11.5 HEAD OF THE DEPARTMENT |DR. MANJUNATH JAJOOR., M.D., D.A. |

| | |Professor and Head, |

| |11.6 SIGNATURE |Department Of Anaesthesiology, |

| | |J.J.M Medical College, |

| | |Davanagere- 577004 |

|12 |REMARKS OF THE CHAIRMAN & PRINCIPAL | |

| | | |

| | | |

| |12.1 SIGNATURE | |

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