1. Dr. V.Philitsen.

2. MY GUIDE PROFESSOR Dr. P.S.SHANMUGAM, M.D.,D.A H.O.D. OF ANESTHESIOLOGY KILPAUK MEDICAL COLLEGE CHENNAI

3. AIM OF THE STUDY To compare the effects of intrathecal fentanyl with 0.5% Bupivaccaine(H) and clonidine with 0.5% Bupivaccaine(H) with control group of patients who received only 0.5% Bupivaccaine(H).

4. STUDY DESIGN Prospective randomised control study After Ethical committee approval Pre – operative assesment done for all cases Informed consent obtained,

5. INCLUSION CRITERIA ASA PS – 1 & 2 patients Both male and female patients Age within 20 and 40 years Patients who have given consent Elective surgeries

6. EXCLUSION CRITERIA Contraindication for spinal anesthesia ASA PS 3,4 & 5 patients Patients who have not given consent Age more than 40 years and less than 20 years

7. Drugs Used -0.5 % Hyperbaric Bupivaccaine -Preservative free Fentanyl -Preservative free Clonidine -0.9 % Normal Saline

8. GROUPS A – 15 mg of 0.5% bupivaccaine(H) + 0.5ml of N.S. B – 15 mg of 0.5% bupivaccaine(H) + 25 µg of Fentanyl C – 15 mg of 0.5% bupivaccaine(H) + 50 µg of clonidine corrected to a volume of 0.5ml by adding N.S.

9. STUDY METHODOLOGY - 45 Patients were assigned to 3 groups 15 each -No patients were sedated intra operatively. -After recording pre-operative vitals intra - venous line was started and pre-loaded with 500 ml of Ringer lactate fluid 15 minutes before the time of spinal anesthesia.

10. -Table was ensured to be horizontal -Under aseptic precautions SAB was done for all patients in right lateral position and in L3-4 space using a 25 G Quincke - Babcock needle -Patients who had hypotension were managed with Ephedrine and intra venous fluids

11. MONITORS -NIBP (for every 5 min.) -ECG -PULSEOXIMETER -TEMPERATURE Vital parameters were monitored for every 5 min in the first hour and every 10 min thereafter.

12. CLINICAL PARAMETERS Maximum sensory level blocked (Until grade 3) Time to achieve maximum sensory level Regression time to L1 (Until grade 0) Onset of grade 4 motor block Regression time to grade 1 motor block Sedation score

13. ASSESSMENT OF SENSORY BLOCK Assessment of sensory loss to pain was done by using 24 gauge intramuscular needle until the patient had grade 3 Sensory block. 0 -Normal sensation of pin prick + -Pin prick felt as sharp pointed but weaker compared with the same area in other side. ++ - Pin prick felt as touch with blunt object +++ -No perception of pin prick HOLLMAN’S SCALE

14. ASSESMENT OF MOTOR BLOCK GradeCriteriaDegree of Block IFree movement of legs and feetNil (0%) II Just able to flex knees with free movement of feet Partial (33%) III Unable to flex knees, but with free movement of feet Almost Complete (66%) IVUnable to move legs or feetComplete (100%) BROMAGE SCORE

15. ASSESMENT OF SEDATION LEVEL 1 - Anxious or agitated or restless 2 – Cooperative,oriented 3 – Responds only to commands but awake 4 – Asleep and brisk response to commands 5 – Asleep and sluggish response to commands 6 – No response to auditory stimulus RAMSEY SEDATION SCORE

18. AGE 95% Confidence Interval for Mean NMeanStd. DeviationStd. ErrorLower BoundUpper Bound 115 31 7.3761.90527.7835.95 215 30 5.4311.40227.7333.74 315 32 6.3381.63629.2936.31 ANOVA AGE Sum of SquaresdfMean SquareSig. Between Groups32.133216.067.681 Within Groups1737.0674241.359

19. HEIGHT 95% Confidence Interval for Mean NMeanStd. DeviationStd. ErrorLower BoundUpper Bound 115 165.60 6.2431.612162.14169.06 215 165.20 6.2131.604161.76168.64 315 164.67 5.3671.386161.69167.64 ANOVA HEIGHT Sum of SquaresdfMean SquareSig. Between Groups6.57823.289.912 Within Groups1489.3334235.460

20. WEIGHT 95% Confidence Interval for Mean NMeanStd. DeviationStd. ErrorLower BoundUpper Bound 1 15 70.53 7.5491.94966.3574.71 2 15 69.07 5.9341.53265.7872.35 3 15 70.33 8.1912.11565.8074.87 ANOVA WEIGHT Sum of SquaresdfMean SquareSig. Between Groups18.97829.489.837 Within Groups2230.0004253.095

22. MAXIMUM SENSORY LEVEL BLOCKED 95% Confidence Interval for Mean NMeanStd. DeviationStd. ErrorLower BoundUpper Bound 115 5 1.424.3684.415.99 215 4.884.2284.445.42 315 5 1.254.3244.315.69 ANOVA MAXIMUM SENSORY LEVEL BLOCKED Sum of SquaresdfMean SquareSig. Between Groups.5782.289.821 Within Groups61.333421.460

23. TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES 95% Confidence Interval for Mean NMeanStd. DeviationStd. ErrorLower BoundUpper Bound 115 28.33 7.9432.05123.9332.73 215 22.80 7.7852.01018.4927.11 315 24.20 7.2131.86220.2128.19 TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES Sum of SquaresdfMean SquareSig. Between Groups248.3112124.156.133 Within Groups2460.1334258.575

24. SENSORY REGRESSION TO L1 MINUTES 95% Confidence Interval for Mean NMeanStd. DeviationStd. ErrorLower BoundUpper Bound 115 171.20 19.9695.156160.14182.26 215 231.00 47.44212.249204.73257.27 315 250.67 35.9509.282230.76270.57 ANOVA SENSORY REGRESSION TO L1 MINUTES Sum of SquaresdfMean SquareSig. Between Groups51388.844225694.422.000 Within Groups55185.733421313.946

25. Multiple Comparisons SENSORY REGRESSION TO L1 MINUTES LSD (I) GROUP(J) GROUP 95% Confidence Interval Mean Difference (I-J)Std. Error Sig. Lower BoundUpper Bound 12 -59.800 * 13.236.000 -86.51-33.09 3 -79.467 * 13.236.000 -106.18-52.76 21 59.800 * 13.236.000 33.0986.51 3 -19.66713.236.145 -46.387.04 31 79.467 * 13.236.000 52.76106.18 2 19.66713.236.145 -7.0446.38 Post Hoc Tests No statistical significance between group 2 and 3 but both groups are significant on comparing to group 1.

26. ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES 95% Confidence Interval for Mean NMeanStd. DeviationStd. ErrorLower BoundUpper Bound 115 10.00 2.619.6768.5511.45 215 6.87 4.1381.0684.589.16 315 5.73 1.870.4834.706.77 ANOVA ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES Sum of SquaresdfMean SquareSig. Between Groups146.533273.267.001 Within Groups384.667429.159

27. Multiple Comparisons ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES LSD (I) GROUP(J) GROUP 95% Confidence Interval Mean Difference (I-J)Std. Error Sig. Lower BoundUpper Bound 12 3.133 * 1.105.007.905.36 3 4.267 * 1.105.000 2.046.50 21 -3.133 * 1.105.007 -5.36-.90 3 1.1331.105.311 -1.103.36 31 -4.267 * 1.105.000 -6.50-2.04 2 -1.1331.105.311 -3.361.10 *. The mean difference is significant at the 0.05 level. Post Hoc Tests No statistical significance between group 2 and 3 but both groups are significant on comparing to group 1.

28. REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES 95% Confidence Interval for Mean NMeanStd. DeviationStd. ErrorLower BoundUpper Bound 115 188.67 20.9995.422177.04200.30 215 234.20 31.4128.111216.80251.60 315 273.00 26.9796.966258.06287.94 ANOVA REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES Sum of SquaresdfMean SquareSig. Between Groups53454.178226727.089.000 Within Groups30177.73342718.517

29. Multiple Comparisons REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES LSD (I) GROUP(J) GROUP 95% Confidence Interval Mean Difference (I-J)Std. Error Sig. Lower BoundUpper Bound 12 -45.533 * 9.788.000 -65.29-25.78 3 -84.333 * 9.788.000 -104.09-64.58 21 45.533 * 9.788.000 25.7865.29 3 -38.800 * 9.788.000 -58.55-19.05 31 84.333 * 9.788.000 64.58104.09 2 38.800 * 9.788.000 19.0558.55 Post Hoc Tests

31. Descriptives NMeanStd. DeviationStd. Error SYSTOLIC115 102.93 10.8722.807 215 98.00 6.9281.789 315 91.47 8.0522.079 DIASTOLIC115 58.00 7.6351.971 215 55.60 10.8022.789 315 47.20 6.6251.710 ANOVA F Sig. MINIMUM BP SYSTOLICBetween Groups6.444.004 MINIMUM BP DIASTOLICBetween Groups6.613.003 BP AT 15 MIN

32. Descriptives NMeanStd. DeviationStd. Error SYSTOLIC115 113.67 10.7952.787 215 107.20 6.2011.601 315 102.33 5.1501.330 DIASTOLIC115 67.20 7.1831.855 215 65.00 7.2411.870 315 58.80 4.2121.088 ANOVA F Sig. MEAN BP SYSTOLICBetween Groups8.014.001 MEAN BP DIASTOLICBetween Groups7.011.002 BP AT 30 MIN

33. Descriptives BP AT 60 MIN NMeanStd. DeviationStd. Error SYSTOLIC115 108.56 10.7952.787 215 100.20 6.2011.601 315 96.33 5.1501.330 DIASTOLIC115 68.20 7.1831.855 215 65.00 7.2411.870 315 52.40 4.2121.088 ANOVA F Sig. MINIMUM BP SYSTOLICBetween Groups6.444.066 MINIMUM BP DIASTOLICBetween Groups6.613.002

34. Descriptives HEART RATE NMeanStd. DeviationStd. Error At 15 min. 115 77.07 9.8232.536 215 73.13 8.1232.097 315 64.47 7.2101.862 At 30 min. 115 89.07 9.3542.415 215 73.87 11.4382.953 315 70.80 8.8332.281

35. HEART RATE NMeanStd. DeviationStd. Error At 60 min. 115 85.01 12.8232.536 215 84.13 9.1232.097 315 71.36 5.2101.862 HEART RATESIGNIFICANCE 15 MIN0.001 30 MIN0.000 60 MIN0.004 ANOVA

36. RAMSEY SEDATION SCORE Score GROUP 1 23 1 15 3 0 2 110 3 17 4 08 TotalCount 15 P= 0.000 SIGNIFICANT.

37. GROUP 1 2 3 15 3 11 1 8 7

39. - Onset of grade 4 motor block was shorter in group 2 and 3 with an average of around 5 to 7 minutes. -Regression to grade 1 motor block is significantly prolonged in group 3 and 2 but group 3 is longer than 2. -Sensory regression to L1 is prolonged in the additive groups but not significantly prolonged while comparing these two groups. -Maximum height of dermatomal block was not significant in all these groups and the time to achieve it was also not significant.

40. -Hemodynamic variables were relatively lower in clonidine group. -All the patients in clonidine group were well sedated.

41. CLONIDINE when used as a spinal additive to hyperbaric bupivaccaine In healthy adults it prolongs the duration of spinal anesthesia but with a hemodynamic variation which can be easily managed while comparing with fentanyl which also prolongs the spinal Anesthesia with not of much variation in the hemodynamic variables. Clonidine has an additional advantage of sedating the patient.

43. REFERENCES Chavda et al Internet Journal of Anesthesia ‘09. Mary Samuel et al IJA ‘07. Stephan Strebe et al Anesth.Analg.’04. Biswas et al IJA ‘02