EL DESARROLLO DEL PENSAMIENTO
3.1 El conocimiento físico
4 Extremities 2 2 Extremities 1 Not Able 0 RESPIRATION:
Able to Breathe Deep and Cough Freely 2 Dyspnoea, Shallow or Limited Breathing 1 Apnoea 0 CIRCULATION:
BP ( 20% of Pre Anaesthetic Level 2 BP( 20-49% of Pre Anaesthetic Level 1 BP( 20-49% of Pre Anaesthetic Level 0 CONSCIOUSNESS:
Fully Awake 2 Arousable on Calling 1 Not Responding 0 OXYGEN SATURATION:
Able to Maintain SaO
2˃ 92% on Room Air 2
Needs Oxygen to Maintain SaO
2˃ 90% 1
Saturation ˂ 90% with Oxygen 0
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APPENDIX D: SUBJECT INFORMATION SHEET
Principal Investigator: DR AARON OLUROTIMI IDOWU.
Telephone No.: 08060118449 E-mail: [email protected]
Institution: Obafemi Awolowo University Teaching Hospitals Complex Ile Ife
Department: ANAESTHESIA
TITLE OF STUDY: A COMPARISON OF TWO DOSES OF SUXAMETHONIUM CHLORIDE IN MODIFIED ELECTROCONVULSIVE THERAPY IN A NIGERIAN TEACHING HOSPITAL.
Co-Investigators (if any): NO CO-INVESTIGATOR
Sponsor (if any): STUDY IS TO BE FUNDED BY THE PRINCIPAL INVESTIGATOR Some general things to know about the study:
Electroconvulsive therapy (ECT) is a procedure in which seizures are caused by a safe dose of carefully regulated electrical current in patients who have been put to sleep. It is prescribed for treatment of drug resistant forms of psychiatric illness. It involves a series of treatments.
The study aims to compare the effects of two doses of suxamethonium, the drug that modifies the induced seizure in two sessions of treatment in a course of ECT. The two doses are within the safe and acceptable range for procedure. To receive each treatment, patients are brought to a specially equipped area in this hospital. Because the treatments involve General
Anaesthesia, the individual is fasted for at least eight hours before each treatment, apart from any medication ordered by the doctor. After being placed on a stretcher in the ECT area, the patient has a medical needle placed in the vein through which fluid and medication will be given. Small quantity of blood will also be withdrawn for laboratory tests. Different devices
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for monitoring are placed on parts of the body, in order to keep track of activities of the heart.
A blood pressure cuff is placed on an arm or leg to measure blood pressure. These monitors are not painful or uncomfortable. When the patient is ready, a medicine is given that quickly puts him or her to sleep. A second drug is given to relax the patient's muscles. Throughout the procedure, the patient receives oxygen through a mask. Breathing is assisted until the patient resumes breathing on his or her own. Because the person is asleep, he or she does not feel pain and is not uncomfortable during the procedure. After the patient is asleep, a small, carefully controlled amount of current is passed between two electrodes that have been placed on the head. When the current is passed through the brain, the intended generalized seizure occurs. Because of the medication received to relax the muscles, the movements in the body that would ordinarily come with this reaction are very much softened. The seizure lasts for about one minute. The amount of current used is adjusted to individual needs, based on the judgment of the physician. Within a few minutes, the medication for sleep wears off and the patient wakes up. He or she is then brought to a recovery room, and is watched over until it is time to leave the ECT area.
PURPOSE: The potential benefit of ECT is that it may lead to improvement in an individual's condition. ECT has been shown to be a treatment that works very well for a number of drug resistant mental illnesses. Anaesthesia with muscle relaxation have reduced physical injuries associated with the procedure.
PROCEDURES: General examination, cardiovascular, respiratory and airway assessment will be carried out. Investigation results will be evaluated. This will be done the night before and just before the commencement of procedure anaesthesia will be induced by propofol (a drug that induces sleep) intravenous 1mg/ kg, followed by suxamethonium chloride
intravenous 0.5mg/kg or 1mg/kg for muscle relaxation before electroconvulsive therapy is
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administered. Supplemental oxygen will be commenced before procedure and maintain until arterial oxygen saturation is satisfactory on room air post procedure.
BENEFITS: Suxamethonium will reduce muscle activities that can cause injury during ECT procedure. The proposed doses are unlikely to interfere with effectiveness of your therapy.
COSTS OF PARTICIPATION: There is no financial cost to you for participating in this study. The study is not expected to prolong the average duration of the routine ECT treatment.
RISKS: Insertion of cannula into the veins for drug administration will cause some pain.
Patient may experience some discomfort due to muscle movements that accompany procedure. Anaesthetic agents to be used may cause reduction in blood pressure and heart rate. These usually are mild and transient. Cessation of breathing is a known effect; this may be prolonged in susceptible individuals. Increased airway secretions, excessive salivation and regurgitation are also known risks.
COMPENSATION: Necessary supportive care, investigations, treatment and referral, where appropriate will be ensured where injury is sustained as a result of participation in the
procedure.
CONFIDENTIALITY: All information gathered in this study will be kept confidential.
When findings of this study are reported to the college, or in scientific journals or meetings, your personal details will not be disclosed. All records and any other study material will be stored in the locked cabinets and accessed by only authorized personnel.
RESPONDENTS’ RIGHTS: Selected subjects have a right to decline participation in the study. Selected subjects who agree to participate in this study have a right to withdraw from
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the study at any stage of the study. Subjects who decline or withdraw from the study shall suffer no disadvantages whatsoever for such action.
CONFLICT OF INTEREST: There is no known conflict of interest.
FOR THE RECORDS: NOT APPLICABLE.
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APPENDIX E: SUBJECT’S AGREEMENT/CONSENT FORM:
I have read the information provided above, or it has been read to me.
I have had the opportunity to ask questions about it and any questions I have asked have been answered to my satisfaction. I consent voluntarily to participate in this study and understand that I have the right to withdraw from the study at any time.
Yes No No
---
Signature / Thumb print of Research Respondent.
Date:
Printed Name of Research Subject’s Legal Guardian.
Signature / thumb print of Person Obtaining Consent.
Date:
Printed Name of Person Obtaining Consent.
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APPENDIX F: OAUTHC ETHICAL COMMITTEE CLEARANCE
77 APPENDIX G: NPMCN APPROVAL
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1. Wagner KJ, Mollenberg O, Rentrop M, Werner C, Kochs EF. Guide to anaesthetic selection for electroconvulsive therapy. CNS drugs. 2005;19:745-58.
2. Taylor S. Electroconvulsive therapy: a review of history, patient selection, technique, and medication management. Southern medical journal. 2007;100:494.
3. Mayo C, Kaye AD, Conrad E, Baluch A, Frost E. Update on anesthesia considerations for electroconvulsive therapy. Middle East journal of anesthesiology. 2010;20:493-8.
4. Lanzenberger R, Baldinger P, Hahn A, Ungersboeck J, Mitterhauser M, Winkler D, et al.
Impact of electroconvulsive therapy on 5-HT1A receptor binding in major depression. Molecular psychiatry. 2013;18:1.
5. Husain SS, Kevan IM, Linnell R, Scott AI. Electroconvulsive therapy in depressive illness that has not responded to drug treatment. Journal of affective disorders. 2004;83:121-6.
6. Mirzakhani H, Welch CA, Eikermann M, Nozari A. Neuromuscular blocking agents for electroconvulsive therapy: a systematic review. Acta anaesthesiologica Scandinavica. 2012;56:3-16.
7. Spindelegger C, Lanzenberger R, Wadsak W, Mien LK, Stein P, Mitterhauser M, et al.
Influence of escitalopram treatment on 5-HT 1A receptor binding in limbic regions in patients with anxiety disorders. Molecular psychiatry. 2009;14:1040-50.
8. Folkerts HW, Michael N, Tolle R, Schonauer K, Mucke S, Schulze-Monking H.
Electroconvulsive therapy vs. paroxetine in treatment-resistant depression -- a randomized study.
Acta psychiatrica Scandinavica. 1997;96:334-42.
9. Hersh JK. Electroconvulsive therapy (ECT) from the patient's perspective. Journal of medical ethics. 2013;39:171-2.
10. Ahmad R, Kenneth T, Mustafa MH. Electroconvulsive therapy: How modern techniques improve patient outcomes. Current Psychiatry. 2012;11:24.
11. Beyer JL, Weiner RD, Glenn MD. Electroconvulsive therapy: a programmed text: American Psychiatric Publishing, Incorporated; 1998.
12. Uppal V, Dourish J, Macfarlane A. Anaesthesia for electroconvulsive therapy. Continuing Education in Anaesthesia, Critical Care & Pain. 2010;10:192-6.
13. Ding Z, White PF. Anesthesia for electroconvulsive therapy. Anesthesia & Analgesia.
2002;94:1351-64.
14. Lee C. Goodbye suxamethonium! Anaesthesia. 2009;64 Suppl 1:73-81.
15. Baraka A. Muscle relaxants for rapid-sequence induction of anesthesia. Middle East journal of anesthesiology. 2004;17:557-68.
16. Folk J, Kellner C, Beale M, Conroy J, Duc T. Anesthesia for electroconvulsive therapy: a review. The journal of ECT. 2000;16:157.
17. Polatin P, Friedman MM, Harris MM, Horwitz WA. Vertebral fractures produced by metrazol-induced convulsions. Journal of the American Medical Association. 1939;112:1684.
18. Holmberg A, Thesleff S. Succinylkolinjodid som muskelavslappande medel via elektroshock behandling. S Nor Med. 1951;46:1567-70.
19. Semkovska M, Keane D, Babalola O, McLoughlin DM. Unilateral brief-pulse
electroconvulsive therapy and cognition: effects of electrode placement, stimulus dosage and time. Journal of psychiatric research. 2011;45:770-80.
20. Peterchev AV, Rosa MA, Deng Z-D, Prudic J, Lisanby SH. ECT stimulus parameters:
rethinking dosage. The journal of ECT. 2010;26:159.
21. Famewo C, Odejide A. Etomidate: Its use in ECT. Ghana Med J. 1979;18:51-3.
22. Odejide AO, Ohaeri JU, Ikuesan BA. Electroconvulsive Therapy in Nigeria. Convuls Ther.
1987;3:31-9.
23. Ukpong DI, Makanjuola RO, Morakinyo O. A controlled trial of modified electroconvulsive therapy in schizophrenia in a Nigerian teaching hospital. West African journal of medicine.
2002;21:237-40.
79
24. Omosofe FO, Bolaji BO, Kolawole IK, Makanjuola AB. Comparative Effects of Thiopentone and Propofol on seizure duration and recovery following modified electroconvulsive therapy in Nigerians. Research Journal of medical Sciences. 2012;6:7-12.
25. Excellence NIfC, Britain G. Guidance on the use of electroconvulsive therapy: National Institute for Clinical Excellence; 2003.
26. Kellner CH, Knapp RG, Petrides G, Rummans TA, Husain MM, Rasmussen K, et al.
Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE). Archives of general psychiatry. 2006;63:1337.
27. Balke LD, Varma A. A case of long-term maintenance ECT in a 78-year-old with depression and possible Parkinson's disease. CNS spectrums. 2007;12:325.
28. Neuhaus A, Katchanov J, Opgen-Rhein C, Neu P, Jockers-Scherübl M. Electroconvulsive Monotherapy in the Treatment of Acute Confusion Psychosis. Pharmacopsychiatry. 2005;38:330-2.
29. Janicak P, Dowd S, Rado J, Welch M. The (re) emerging role of therapeutic neuromodulation. Curr Psychiatry. 2010;9:66-74.
30. Wahlund B, von Rosen D. ECT of major depressed patients in relation to biological and clinical variables: a brief overview. Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology. 2003;28:S21-6.
31. Nobler MS, Oquendo MA, Kegeles LS. Decreased regional brain metabolism after ECT.
American Journal of Psychiatry. 2001;158:305-8.
32. Saito S. Anesthesia management for electroconvulsive therapy: hemodynamic and respiratory management. Journal of Anesthesia. 2005;19:142-9.
33. Weinger MB, Partridge BL, Hauger R, Mirow A. Prevention of the cardiovascular and neuroendocrine response to electroconvulsive therapy: I. Effectiveness of pretreatment regimens on hemodynamics. Anesthesia & Analgesia. 1991;73:556-62.
34. Huang KC, Lucas LF, Tsueda K, Thomas MH, Lippmann SB. Age-Related Changes in
Cardiovascular Function Associated with Electroconvulsive Therapy. The journal of ECT. 1989;5:17-25.
35. Takagi S, Iwata K, Nakagawa A. Relationship between body mass index and blood pressure elevation during electroconvulsive therapy. Journal of clinical anesthesia. 2012;24:33-7.
36. Weiner RD. The practice of electroconvulsive therapy: recommendations for treatment, training, and privileging (A Task Force Report of the American Psychiatric Association): American Psychiatric Pub; 2008.
37. Sadock BJ. Kaplan and Sadock's synopsis of psychiatry: Behavioural Sciences/Clinical Psychiatry. 10th ed: Lippincott Williams & Wilkins; 2007.
38. Farashbandi H, Emdadi V, Haghshenas H, Khaloo V, Kianpoor M. The Effect of Atropine on Post-ECT Bradycardia in Patients with Major Depressive Disorder. Zahedan Journal of Research in Medical Sciences. 2014;16:6-9.
39. Rasmussen P, Andersson J-E, Koch P, Secher NH, Quistorff B. Glycopyrrolate prevents extreme bradycardia and cerebral deoxygenation during electroconvulsive therapy. The journal of ECT. 2007;23:147-52.
40. Scott AI. The ECT Handbook: The Second Report of the Royal College of Psychiatrists' Special Committee on ECT: RCPsych Publications; 2005.
41. Nishiyama M, Togashi H. [Effects of anesthetic agents on seizure duration and hemodynamics in electroconvulsive therapy]. Masui The Japanese journal of anesthesiology.
2009;58:1266-9.
42. Takada J, Solimene M, Da Luz P, Grupi C, Giorgi D, Rigonatti S, et al. Assessment of the cardiovascular effects of electroconvulsive therapy in individuals older than 50 years. Brazilian journal of medical and biological research. 2005;38:1349-57.
43. Kenning T, Mago R, Huege S, Certa K, Pelchat R. Electroconvulsive therapy: A review of its current status. Jefferson Journal of Psychiatry. 2012;19:1.
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44. Bansal S, Surve R, Sriganesh K, Tirthalli J, Subbakrishna D, Umamaheswara Rao G. Influnce of acute haemodynamic changes on the oxygen saturation during electro-convulsive therapy J Neuroanaesthesiol Crit Care. 2014;1:46-9.
45. Avramov MN, Husain MM, White PF. The comparative effects of methohexital, propofol, and etomidate for electroconvulsive therapy. Anesthesia & Analgesia. 1995;81:596-602.
46. Zaidi NA, Khan FA. Comparison of thiopentone sodium and propofol for electro convulsive therapy (ECT). JPMA The Journal of the Pakistan Medical Association. 2000;50:60-3.
47. Yentis SM, Hirsch NP, Smith GB. Propofol. Anaesthesia and Intensive Care A-Z An
Encyclopaedia of Principles and Practice. Third ed. Philadelphia: Elsevier Butterworth Heinemann;
2004. p. 431.
48. Sasada M, Smith S. Propofol. Drugs in Anaesthesia and Intensive Care. Second ed.
Newyork: Oxford University Press; 1998. p. 314-6.
49. Gupta A, Stierer T, Zuckerman R, Sakima N, Parker SD, Fleisher LA. Comparison of recovery profile after ambulatory anesthesia with propofol, isoflurane, sevoflurane and desflurane: a systematic review. Anesthesia & Analgesia. 2004;98:632-41.
50. Lim SK, Lim WL, Elegbe EO. Comparison of propofol and methohexitone as an induction agent in anaesthesia for electroconvulsive therapy. West African journal of medicine. 1996;15:186-9.
51. Geretsegger C, Nickel M, Judendorfer B, Rochowanski E, Novak E, Aichhorn W. Propofol and methohexital as anesthetic agents for electroconvulsive therapy: a randomized, double-blind comparison of electroconvulsive therapy seizure quality, therapeutic efficacy, and cognitive performance. The journal of ECT. 2007;23:239-43.
52. Saito S, Kadoi Y, Nara T, Sudo M, Obata H, Morita T, et al. The comparative effects of propofol versus thiopental on middle cerebral artery blood flow velocity during electroconvulsive therapy. Anesthesia & Analgesia. 2000;91:1531-6.
53. Korttila K, Nuotto EJ, Lichtor JL, Östman PL, Apfelbaum J, Rupani G. Clinical recovery and psychomotor function after brief anesthesia with propofol or thiopental. Anesthesiology.
1992;76:676-81.
54. Calarge CA, Crowe RR, Gergis SD, Arndt S, From RP. The Comparative Effects of
Sevoflurane and Methohexital for Electroconvulsive Therapy. The journal of ECT. 2003;19:221-5.
55. Morgan AA. Apnoea following suxamethonium: the genetic study of four generations of a family. Journal of medical genetics. 1982;19:22-5.
56. Fredman B, Smith I, d'Etienne J, White PF. Use of muscle relaxants for electroconvulsive therapy: how much is enough? Anesthesia and analgesia. 1994;78:195-6.
57. Murali N, Saravanan ES, Ramesh VJ, Gangadhar BN, Jananakiramiah N, Kumar SS, et al. An intrasubject comparison of two doses of succinylcholine in modified electroconvulsive therapy.
Anesthesia and analgesia. 1999;89:1301-4.
58. Pitts Jr FN, Woodruff Jr RA, Craig AG, Rich CL. The drug modification of ECT: II.
Succinylcholine dosage. Archives of general psychiatry. 1968;19:595.
59. Konarzewski WH, Milosavljevic D, Robinson M, Banham W, Beales F. Suxamethonium dosage in electroconvulsive therapy. Anaesthesia. 1988;43:474-6.
60. Freeman C. The ECT handbook: the second report of the Royal College of Psychiatrists' Special Committee on ECT: Royal College of Psychiatrists; 1995.
61. Bali IM. The effect of modified electroconvulsive therapy on plasama potassium concentration. British journal of anaesthesia. 1975;47:398-401.
62. Valentin N, Skovsted P, Danielsen B. Plasma potassium following suxamethonium and electroconvulsive therapy. Acta anaesthesiologica Scandinavica. 1973;17:197-202.
63. McCleane G, Howe J. Electroconvulsive therapy and serum potassium. The Ulster medical journal. 1989;58:172.
64. Cheam EW, Critchley LA, Chui P, Yap JC, Ha VW. Low dose mivacurium is less effective than succinylcholine in electroconvulsive therapy. Canadian Journal of Anesthesia. 1999;46:49-51.