ADDIS ABABA UNIVERSITY COLLEGE OF HEALTH SCIENCES, SCHOOL OF GRADUATE STUDIES DEPARTMENT OF ANESTHESIA Efficacy of Meperidine versus Tramadol as a treatment agent on post spinal anaesthesia shivering, hemodynamic stability and therapeutic side effects in parturients at Mateme Gandhi Memorial Hospital, Addis Ababa, Ethiopia, from 1Dec-2016 to 28-Feb-2017: A Prospective Cohort Study By: Ashenafi Seifu (BSc, MSc student) Advisor: Adugna Aregawi (BSc, MSc) Signature _ Research thesis prepared for partial fulfillment of the requirements for the masters of sciences degree in Advanced Clinical Anesthesia June, 2017 Addis Ababa, Ethiopia I CERTIFICATION The undersigned certify that the research entitled Efficacy of Meperidine versus Tramadol as a treatment agent on post spinal anaesthesia shivering, hemodynamic stability and therapeutic side effects in parturients at Mateme Gandhi Memorial Hospital, Addis Ababa, Ethiopia, from 1-Dec2016 to 28-Feb-2017: A Prospective Cohort Study is my original work and any literature and/or data cited in this article were listed in the reference section and any assist done during this period has been given an acknowledgement Author Name Signature Date Approval of the Board of Examiners Advisor Name Signature Date Internal Examiner Name _ Signature Date External Examiner Name Signature Date II ABBREVIATIONS AND ACRONYMS ASA- American Society of Anesthesiology BMI-Body Mass Index C/S- Cescerean Section EAA- Ethiopian Association of Anesthetists ECG-Electro Cardio Graph FMOH- Federal Ministry of Health HR-Heart Rate IQR- Inter Quartile Range IRB- Institutional Review Board ICP-Intra Cranial Pressure IOP-Intra Ocular Pressure I.V-Intravenous OR-Operating Room REC-Research Ethical Committee MAP-Mean Arterial Pressure PACU-Post Anesthesia Care Unit PSAS-Post Spinal Anesthesia Shivering SA- Spinal Anesthesia SD- Standard Deviation SPSS-Statistical Package for social sciences SPO2 -Arterial oxygen saturation V/S-Vital Signs III List of tables Table I: Socio-demographic and operative values related with anesthesia and surgery of the study participants in Mateme Gandhi Memorial Hospital from 1, Dec,2016 to 28, feb,2017 Table II.1: Independent samples t-test Analysis of the mean arterial pressure (MAP) between tramadol and meperidine in Mateme Gandhi Memorial Hospital from 1-Dec-2016 to 28-Feb-2017 Table II.2: Independent samples t-test Analysis of the heart rate (HR) between tramadol and meperidine in Mateme Gandhi Memorial Hospital from 1-Dec-2016 to 28-Feb-2017 Table II.3: Independent samples t-test Analysis of the arterial saturation (Spo2) between tramadol and meperidine in Mateme Gandhi Memorial Hospital from 1-Dec-2016 to 28-Feb-2017 Table II.4: Independent samples t-test Analysis of the body temperature between tramadol and meperidine in Mateme Gandhi Memorial Hospital from 1-Dec-2016 to 28-Feb-2017 Table III: Independent samples t-test Analysis of the duration of time from treatment to cessation of PSAS and therapeutic side effects between tramadol and meperidine in Mateme Gandhi Memorial Hospital, Addis Ababa Ethiopia, from 1-Dec-2016 to 28-Feb-2017 List of figures Figure1: The conceptual framework Figure 2: Enrollment of study participants Figure 3: Comparison of observed PSAS grade distribution between tramadol and meperidine IV Contents ABBREVIATIONS AND ACRONYMS III List of tables IV List of figures IV ACKNOWLEDGEMENT VII ABSTRACT VIII Background: VIII Objective: VIII Methods and Materials: VIII Results: VIII Conclusion: VIII CHAPTER ONE: INTRODUCTION 1.1 Background 1.2 Statement of the problem 1.3 Justification of the study CHAPTER TWO: LITERATURE REVIEW 2.1 Review of literature 2.2 Conceptual framework CHAPTER THREE: OBJECTIVES 3.1 General Objective 3.2 Specific objectives: CHAPTER FOUR: METHODS AND MATERIALS 4.1 Study Design and Period 4.2 Study Area 4.3 Source and study Population 4.3.1 Source population 4.3.2 Study population 4.3.3 Study units 4.4 Eligibility Criteria 4.4.1 Inclusion criteria 4.4.2 Exclusion criteria 4.5 Variables 4.5.1 Dependent variable: V 4.5.2 Independent variables: 4.6 Operational definition 4.7 Sample size and sampling technique 10 4.7.1 Sample size 10 4.7.2 Sampling technique 10 4.8 Implementation of observation and measurement variable 11 4.9 Data collection technique and instrument 13 4.10 Data quality assurance 13 4.11 Data processing and analysis 13 4.12 Ethical consideration 14 4.13 Presentation and dissemination of Results 14 CHAPTER FIVE: RESULTS 15 5.1 Socio-demographic and operative values 15 Table I: Socio-demographic and operative values between Meperidine and Tramadol groups.…….15 5.2 Hemodynamic changes 17 Table II: Hemodynamic changes between meperidine and tramadol at different times………….…17 5.3 Reoccurrence of PSAS, duration to stop PSAS and therapeutic side effects 19 Table III: Efficacy in minutes, reoccurrences and treatment side effects between groups………….20 CHAPTER SIX: DISCUSSION 21 6.1 Discussion 21 6.2 Strength of the study 22 6.3 Limitations of the study 22 CHAPTER SEVEN: CONCLUSION AND RECOMMENDATIONS 23 7.1 Conclusion 23 7.2 Recommendations 23 REFERENCES 24 9.ANNEXES 28 Annex I Consent and questionnaire 28 Annex II.1-: Dummy table 33 Annex II.2-: Information sheet 34 VI ACKNOWLEDGEMENT I would like to thank the ultimate God for all his blessings It’s also my pleasure to acknowledge my advisor Mr Adugna Aregawi (MSc in ACA) for his immense guide up to this thesis through his scientific view I would also extend my appreciation to department of Anesthesia, Addis Ababa University for providing me with all the necessary supports My gratitude also goes to my brother Shimelis Wondimu (PHD fellow at Addis Ababa University), His wife Sr Felekech Demissew, my family and my friends, who are not explicitly named, for their incredible comments and follow up in conducting this research VII ABSTRACT Background: Spinal anesthesia is most commonly preferred anesthesia types in the clinical practice Post Spinal Anesthesia Shivering (PSAS) is one of the frequent side effects of spinal anesthesia and results in ill patient outcome It occurs during both general and spinal anesthesia, but it is more cumbersome during spinal anesthesia From many approaches tried to overcome this problem; non-pharmacological one is supper effective in prevention of PSAS But it is very costly and not applicable in all settings The pharmacological approach is more commonly used and is accessible in almost all settings Objective: The objective of the study was to compare the therapeutic effect of meperidine and Tramadol in control of PSAS during elective cescerean section in parturient who gave birth under spinal anesthesia, in the quest for a drug with more efficacy and less side effects Methods and Materials: In this prospective cohort study 74 parturients of ASA I and II who underwent elective cescerean delivery under spinal anesthesia and developed PSAS at Gandhi Memorial Hospital from Dec 1, 2016-Feb 28, 2017 were included Parturients were treated with either Meperidine 0.5 mg/kg (n=37) Tramadol 0.5mg/kg (n=37) depending on inclusion criteria Time from treatment to cessation of PSAS in minutes, Hemodynamic variables before spinal anesthesia (baseline), after spinal anaesthesia, at 5,10 and 30 minutes after PSAS was treated were taken Reoccurrence of PSAS and therapeutic side effects were recorded Data were entered into Epi info version and exported to SPSS version 20 for analysis Differences of Categorical data were analyzed with the Chi-Square test Numerical data between groups were evaluated using independent samples t-test or Mann-Whitney U test A p value of