RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, …



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA BANGALORE

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

|1 |Name of the Candidate and Address (in block |DR SHIVAKUMAR . M. |

| |letters) | |

| | |POST GRADUATE STUDENT , |

| | |DEPARTMENT OF ANAESTHESIOLOGY, BMC&RI, BANGALORE- 560002. |

|2 |Name of the Institute |BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, |

| | |BANGALORE. |

|3 |Course and Subject |DOCTOR OF MEDICINE IN |

| | |ANAESTHESIOLOGY. |

|4 |Date of Admission to Course |17-05-2010. |

|5 |Title of the Topic |“STUDY OF SPECTRAL ENTROPY GUIDED PROPOFOL REQUIREMENT DURING INDUCTION OF |

| | |GENERAL ANAESTHESIA”. |

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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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|Entropy of electroencephalogram (EEG) quantifies the degree of chaos, complexity or irregularity of the EEG signal. The EEG activity would show|

|more regularity in anaesthetized, than in awake patients. 1 |

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|Spectral Entropy is a new EEG derived parameter that may be used to model the pharmacokinetic- pharmacodynamic effects of General Anaesthestics.|

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|Datex-Ohmeda (Datex-Ohmeda division, Instrumentarium Corp., Helsinki, Finland) has developed a commercially available depth of anaesthesia |

|monitor, the Entropy Module that is based on the time frequency balanced Spectral Entropy of the EEG. The two output parameters called the State|

|Entropy (SE) & Response Entropy (RE) represent the Entropy scales. 2 |

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|The output values can range between 0-91 for State Entropy and 0-100 for Response Entropy. 2 State Entropy is computed over a frequency range |

|from 0.8-32 Hz & Response Entropy is computed over a frequency range from 0.8-47 Hz. 1 For fully awake responsive subjects, a value of 100 for |

|Response Entropy and 91 for State Entropy is observed respectively and a difference between these parameters is usually < 10. 3 |

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|For a clinically meaningful anaesthesia and low probability of consciousness following an administration of a General Anaesthetic (GA) in a |

|patient, a Response Entropy value of 40-60 is considered as appropriate with Response Entropy - State Entropy difference of less than 10. 3 |

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|In recent years, Propofol is used commonly as an intravenous induction agent during General Anaesthesia as the recovery is smooth and clear. |

|High doses of Propofol can cause some side effects like hypotension, respiratory depression, vasodilatation etc, which may affect the patients |

|who undergo surgeries under GA. Therefore, it is essential to optimize the dose of Propofol during induction. |

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|In view of the above and as Spectral Entropy monitoring is a fast and simple method of analysis of the EEG, 4 it is proposed to study how this |

|new device helps in decreasing the requirement of Propofol during induction of General Anaesthesia. |

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|REVIEW OF LITERATURE: |

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|P. Hans and his colleagues investigated the effect of Nitrous oxide on Response and State Entropy of the EEG during Lumbar surgery under |

|General anaesthesia induced with Propofol and maintained with Sevoflurane. The study concluded that there was a decrease in both Response and |

|State Entropy values, thereby highlighting the fact that Entropy is helpful in monitoring the depth of anaesthesia. 1 |

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|Ian D. H. Mckay and others used the Datex- Ohmeda Entropy Module to demonstrate the Pharmacokinetic- Pharmacodynamic effects of Volatile |

|anaesthetics. 2 |

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|W. Riad, M. Schreiber, A.B. Saeed in their study on 72 patients, demonstrated that the use of EEG Entropy monitoring during induction of General|

|Anaesthesia, reduces Propofol requirement in elderly patients.3 |

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|An editorial published in BJA, quoted the study in which they had demonstrated that the administration of incremental doses of Propofol to the |

|point of loss of responsiveness, causes a concomitant decrease in the Spectral Entropy of the EEG compared with alert, baseline values.4 |

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|Vakkuri and his other colleagues have proved in their study that Entropy monitoring, assisted titration of Propofol, decreased consumption of |

|Propofol and had shorter recovery times in the entropy group.5 |

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|A study conducted on 72 patients M. Gruenewald and others regarding Entropy guidance Vs Standard practice during Propofol Anaesthesia |

|demonstrated that Standard practice group required more Propofol than the Entropy group.6 |

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|Kreuer showed in their study that Narcotrend and Bispectral Index(BIS) monitoring are equally effective to facilitate a significant reduction of|

|recovery times and Propofol consumption when used for guidance of Propofol titration.7 |

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|A.L.G. Vanluchene and others in their comparison study with BIS done on three groups of 30 patients each, have shown that though Response |

|Entropy and State Entropy were influenced by Remifentanil during Propofol administration, their ability to detect Loss of Response to verbal |

|commands remained accurate.8 |

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|A study done on 70 patients by A. Vakkuri and others showed that Response Entropy, State Entropy and BIS distinguished excellently between |

|consciousness and unconsciousness states during Propofol, Sevoflurane and Thiopentone anaesthesia.9 |

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|AIMS & OBJECTIVES OF STUDY: |

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|To quantify the dose of Propofol in Entropy and Control group. |

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|To ascertain whether Entropy monitoring decreases the requirement of Propofol during induction of General Anaesthesia. |

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|7. MATERIALS AND METHODS: |

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|7.1 SOURCE OF DATA: |

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|a) Patients posted for elective general surgeries at Victoria Hospital and Bowring & Lady Curzon Hospital attached to Bangalore Medical College &|

|Research Institute, Bangalore. |

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|b) The design of the study is Case- Control study. |

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|c) The minimum sample has been calculated at 5% level of significance and a power of 80% to detect at least 30% difference in the dose of propofol|

|needed between two groups assuming an equal standard deviation in each group. Accordingly, the total sample size is 94 ie, 47 each in Entropy group|

|& Control group. A 10% extra will be included to accommodate inadequate -response, non-response etc.,. Thus, in all 100 subjects would be recruited|

|with equal numbers in case and control groups. |

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|Data collection would be undertaken during the period November 2010 to 30th September 2012. |

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|7.2 METHOD OF COLLECTION OF DATA: |

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|INCLUSION CRITERIA: |

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|Patients with physical status ASA I & II. |

|Patients aged between 18-50 years. |

|Valid informed consent. |

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|EXCLUSION CRITERIA: |

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|Patients with H/o Hepatic and Renal disorders. |

|Patients with H/o Convulsions and neurological deficits. |

|Patients with Neuromuscular disorders. |

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|7.3 METHODOLOGY: |

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|Based on the above criteria, patients posted for elective surgeries are allocated randomly to Entropy group (E) and Control group(C). |

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|All patients are fasted for at least six hours before anaesthesia. IV access is obtained and standard monitoring devices like ECG, Pulse oximetry, |

|NIBP are applied. The Spectral Entropy is |

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|measured with a plug- in Datex- Ohmeda M-Entropy S/5 Module. A composite electrode, the Entropy Sensor, composed of a self- adhering flexible band |

|holding three electrodes is applied to the forehead and temple. |

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|All patients are allowed to breathe 100% Oxygen for 2-3 minutes before induction of anaesthesia. |

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|For the Entropy group (E), Propofol is administered for induction in successive 30mg doses every 2 minutes, until Response Entropy values dropped |

|to 50 and Response Entropy – State Entropy difference is less than 10; this is clinically confirmed with loss of Response to verbal commands and |

|loss of eyelash reflex. |

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|The Control group (C), patients are administered the recommended dose of Propofol at induction in the same manner as the Entropy group. The |

|investigator is not guided by the fall in EEG Entropy reading rather; it is confirmed clinically by loss of response to verbal commands and loss of|

|eye lash reflex . |

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|State Entropy (SE) and Response Entropy (RE) values are recorded at different points- |

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|Baseline value before induction. |

|After induction and before intubation. |

|1 minute after intubation. |

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|After collection of data at 2nd point, Fentanyl 2mcg/Kg with Atracurium 0.5mg/Kg is given followed by endotracheal intubation. During intubation, |

|if there is any increase in the reading of Entropy, an additional dose of Propofol 20-30 mg bolus is administered until no increase in Entropy |

|values are observed, and then intubation is performed. |

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|Total dose of Propofol is recorded and dose of Propofol/Kg BW is also calculated. |

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|Anaesthesia is further maintained by standard anaesthetic practice throughout the surgery. |

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|STATISTICAL METHODS: |

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|Statistical evaluation and analysis of the data will be done by unpaired two tailed‘t’ test and ANOVA. |

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|7.4 Does the study require any investigation or intervention to be conducted on patients or other humans or animals? If so, please describe |

|briefly. |

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|a) It does not require any intervention on animals. |

|b) Investigations only on patients with their consent- |

|Routine blood investigations like hemoglobin, bleeding time, clotting time. |

|Blood sugar levels |

|Renal parameters-Blood Urea, Serum Creatinine and electrolytes. |

|Chest radiograph |

|ECG |

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|7.5 Has ethical clearance been obtained from your Institution? |

|Yes. |

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|8. LIST OF REFERENCES: |

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|P. Hans, P. Y. Dewandre, J. F. Brichant, V. Bonhomme, Effects of Nitrous Oxide on Spectral Entropy of the EEG during surgery under balanced |

|anaesthesia with Sufentanil and Sevoflurane, Acta Anaesthesiologica Belgica 2005;56:37-43. |

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|Ian D. H. Mckay, Logan J. Voss. James W. Sleigh, john P. Barnard, Ewa K. Johannsen, Pharmacokinetic-Pharmacodynamic modeling the hypnotic effect of|

|Sevoflurane using the Spectral Entropy of the Electroencephalogram, Anaesthesia and Analgesia 2006;102:91-97. |

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|W.Riad, M.Schreiber, A.B. Saeed , Monitoring with EEG Entropy decreases Propofol requirement and maintains Cardio vascular stability in elderly |

|patients, European Journal of Anaesthesiology 2007; 24:684-688. |

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|Andersson RE, Jackobsson JG, Entropy of EEG during anaesthesia induction: a comparative study with Propofol or Nitrous oxide as sole agent, British|

|Journal of Anaesthesiology 2004;92:167-170. |

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|Vakkuri, Anne, Yli-Hankala, Spectral entropy monitoring is associated with reduced Propofol use & faster emergence in Propofol- N2O-Alfentanil |

|anaesthesia, Anaesthesiology 2005;103(2):274-279. |

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|M. Gruenewald, J. Zhou, N. Schloemerkemper, Entropy guidance Vs Standard practice during Propofol – Remefentanil anaesthesia: a randomized |

|controlled trial, Anaesthesia 2007;62(12):1224-1229. |

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|Kreuer, Sascha, Biedler, Narcotrend monitoring allows faster emergence and a reduction of drug consumption in Propofol – Remefentanil anaesthesia, |

|Anaesthesiology 2003;99(1):34-41. |

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|A.L.G. Vanluchene, M.M.R.F.Struys, B.E.K.Heyse & E.P.Mortier, Spectral entropy measurement of patient responsiveness during Propofol and |

|Remefentanil: A comparison with BIS, British Journal of Anaesthesiology 2004;93(5):645-654. |

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|A. Vakkuri, A. Yli-Hankala, Time frequency balanced Spectral entropy as a measure of anaesthetic drug effect in Central nervous system during |

|Propofol, Sevoflurane & Thiopentone anaesthesia, Acta Anaesthesiologica Scandinavica 2004;48(2):145-153. |

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|9. |

|Signature of Candidate |

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|10. |

|Remarks of Guide |

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|The available clinical information suggests that use of Entropy can avoid use of unnecessary excess dose of Propofol, which may be significant in |

|high risk patients. This study can quantify the amount of Propofol needed to induce Anaesthesia. |

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|11 |

|Name & Designation of (in block letters) |

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|DR S.S.HARSOOR |

|PROFESSOR OF ANAESTHESIOLOGY, VICTORIA HOSPITAL, |

|BMC& RI, BANGALORE. |

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|11.1 Guide |

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|11.2 Signature |

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|11.3 Co-Guide (if any) |

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|11.4 Signature |

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|11.5 Head of the Department |

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|DR T.N.SRIKANTAMURTHY |

|PROFESSOR & HOD |

|DEPARTMENT OF ANAESTHESIOLOGY |

|BMC & RI, BANGALORE. |

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|11.6 Signature |

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|12 |

|12.1 Remarks of the Principal |

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|12.2 Signature |

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