1
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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