COMPARISON OF EFFECTS OF SPINAL ADDITIVES FENTANYL and CLONIDINE WITH HYPERBARIC BUPIVACCAINE

1
COMPARISON OF EFFECTS OF SPINAL
ADDITIVESFENTANYL and CLONIDINE WITH
HYPERBARIC BUPIVACCAINE
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 -T
EMPERATURE
Vital parameters were monitored for every 5
min in the first hour and every 10 min
thereafter.
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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
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ASSESSMENT OF SENSORY BLOCK
HOLLMANS SCALE
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
Assessment of sensory loss to pain was
done by using 24 gauge intramuscular needle
until the patient had grade 3 Sensory
block.
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ASSESMENT OF MOTOR BLOCK
BROMAGE SCORE
Grade Criteria Degree of Block
I Free movement of legs and feet Nil (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)
IV Unable to move legs or feet Complete (100)
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ASSESMENT OF SEDATION LEVEL
RAMSEY SEDATION SCORE
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
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STATISTICAL ANALYSIS
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DEMOGRAPHIC DETAILS
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AGE AGE AGE AGE AGE AGE AGE
95 Confidence Interval for Mean 95 Confidence Interval for Mean
N Mean Std. Deviation Std. Error Lower Bound Upper Bound
1 15 31 7.376 1.905 27.78 35.95
2 15 30 5.431 1.402 27.73 33.74
3 15 32 6.338 1.636 29.29 36.31

ANOVA ANOVA ANOVA ANOVA ANOVA
AGE AGE AGE AGE AGE
Sum of Squares df Mean Square Sig.
Between Groups 32.133 2 16.067 .681
Within Groups 1737.067 42 41.359

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HEIGHT HEIGHT HEIGHT HEIGHT HEIGHT HEIGHT HEIGHT
95 Confidence Interval for Mean 95 Confidence Interval for Mean
N Mean Std. Deviation Std. Error Lower Bound Upper Bound
1 15 165.60 6.243 1.612 162.14 169.06
2 15 165.20 6.213 1.604 161.76 168.64
3 15 164.67 5.367 1.386 161.69 167.64

ANOVA ANOVA ANOVA ANOVA ANOVA
HEIGHT HEIGHT HEIGHT HEIGHT HEIGHT
Sum of Squares df Mean Square Sig.
Between Groups 6.578 2 3.289 .912
Within Groups 1489.333 42 35.460

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WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT
95 Confidence Interval for Mean 95 Confidence Interval for Mean
N Mean Std. Deviation Std. Error Lower Bound Upper Bound
1 15 70.53 7.549 1.949 66.35 74.71
2 15 69.07 5.934 1.532 65.78 72.35
3 15 70.33 8.191 2.115 65.80 74.87

ANOVA ANOVA ANOVA ANOVA ANOVA
WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT
Sum of Squares df Mean Square Sig.
Between Groups 18.978 2 9.489 .837
Within Groups 2230.000 42 53.095

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CLINICAL PARAMETERS
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MAXIMUM SENSORY LEVEL BLOCKED MAXIMUM SENSORY LEVEL BLOCKED MAXIMUM SENSORY LEVEL BLOCKED MAXIMUM SENSORY LEVEL BLOCKED MAXIMUM SENSORY LEVEL BLOCKED MAXIMUM SENSORY LEVEL BLOCKED MAXIMUM SENSORY LEVEL BLOCKED
95 Confidence Interval for Mean 95 Confidence Interval for Mean
N Mean Std. Deviation Std. Error Lower Bound Upper Bound
1 15 5 1.424 .368 4.41 5.99
2 15 4 .884 .228 4.44 5.42
3 15 5 1.254 .324 4.31 5.69

ANOVA ANOVA ANOVA ANOVA ANOVA
MAXIMUM SENSORY LEVEL BLOCKED MAXIMUM SENSORY LEVEL BLOCKED MAXIMUM SENSORY LEVEL BLOCKED MAXIMUM SENSORY LEVEL BLOCKED MAXIMUM SENSORY LEVEL BLOCKED
Sum of Squares df Mean Square Sig.
Between Groups .578 2 .289 .821
Within Groups 61.333 42 1.460

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TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES
95 Confidence Interval for Mean 95 Confidence Interval for Mean
N Mean Std. Deviation Std. Error Lower Bound Upper Bound
1 15 28.33 7.943 2.051 23.93 32.73
2 15 22.80 7.785 2.010 18.49 27.11
3 15 24.20 7.213 1.862 20.21 28.19

TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES
Sum of Squares df Mean Square Sig.
Between Groups 248.311 2 124.156 .133
Within Groups 2460.133 42 58.575

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SENSORY REGRESSION TO L1 MINUTES SENSORY REGRESSION TO L1 MINUTES SENSORY REGRESSION TO L1 MINUTES SENSORY REGRESSION TO L1 MINUTES SENSORY REGRESSION TO L1 MINUTES SENSORY REGRESSION TO L1 MINUTES SENSORY REGRESSION TO L1 MINUTES
95 Confidence Interval for Mean 95 Confidence Interval for Mean
N Mean Std. Deviation Std. Error Lower Bound Upper Bound
1 15 171.20 19.969 5.156 160.14 182.26
2 15 231.00 47.442 12.249 204.73 257.27
3 15 250.67 35.950 9.282 230.76 270.57

ANOVA ANOVA ANOVA ANOVA ANOVA
SENSORY REGRESSION TO L1 MINUTES SENSORY REGRESSION TO L1 MINUTES SENSORY REGRESSION TO L1 MINUTES SENSORY REGRESSION TO L1 MINUTES SENSORY REGRESSION TO L1 MINUTES
Sum of Squares df Mean Square Sig.
Between Groups 51388.844 2 25694.422 .000
Within Groups 55185.733 42 1313.946

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Post Hoc Tests
Multiple Comparisons Multiple Comparisons Multiple Comparisons Multiple Comparisons Multiple Comparisons Multiple Comparisons Multiple Comparisons
SENSORY REGRESSION TO L1 MINUTES LSD SENSORY REGRESSION TO L1 MINUTES LSD SENSORY REGRESSION TO L1 MINUTES LSD SENSORY REGRESSION TO L1 MINUTES LSD SENSORY REGRESSION TO L1 MINUTES LSD SENSORY REGRESSION TO L1 MINUTES LSD SENSORY REGRESSION TO L1 MINUTES LSD
(I) GROUP (J) GROUP 95 Confidence Interval 95 Confidence Interval
(I) GROUP (J) GROUP Mean Difference (I-J) Std. Error Sig. Lower Bound Upper Bound
1 2 -59.800 13.236 .000 -86.51 -33.09
1 3 -79.467 13.236 .000 -106.18 -52.76
2 1 59.800 13.236 .000 33.09 86.51
2 3 -19.667 13.236 .145 -46.38 7.04
3 1 79.467 13.236 .000 52.76 106.18
3 2 19.667 13.236 .145 -7.04 46.38
No statistical significance between group 2
and 3 but both groups are significant on
comparing to group 1.
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ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES
95 Confidence Interval for Mean 95 Confidence Interval for Mean
N Mean Std. Deviation Std. Error Lower Bound Upper Bound
1 15 10.00 2.619 .676 8.55 11.45
2 15 6.87 4.138 1.068 4.58 9.16
3 15 5.73 1.870 .483 4.70 6.77

ANOVA ANOVA ANOVA ANOVA ANOVA
ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES
Sum of Squares df Mean Square Sig.
Between Groups 146.533 2 73.267 .001
Within Groups 384.667 42 9.159

27
Post Hoc Tests
Multiple Comparisons Multiple Comparisons Multiple Comparisons Multiple Comparisons Multiple Comparisons Multiple Comparisons Multiple Comparisons
ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES LSD ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES LSD ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES LSD ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES LSD ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES LSD ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES LSD ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES LSD
(I) GROUP (J) GROUP 95 Confidence Interval 95 Confidence Interval
(I) GROUP (J) GROUP Mean Difference (I-J) Std. Error Sig. Lower Bound Upper Bound
1 2 3.133 1.105 .007 .90 5.36
1 3 4.267 1.105 .000 2.04 6.50
2 1 -3.133 1.105 .007 -5.36 -.90
2 3 1.133 1.105 .311 -1.10 3.36
3 1 -4.267 1.105 .000 -6.50 -2.04
3 2 -1.133 1.105 .311 -3.36 1.10
. The mean difference is significant at the 0.05 level. . The mean difference is significant at the 0.05 level. . The mean difference is significant at the 0.05 level. . The mean difference is significant at the 0.05 level. . The mean difference is significant at the 0.05 level. . The mean difference is significant at the 0.05 level. . The mean difference is significant at the 0.05 level.
No statistical significance between group 2
and 3 but both groups are significant on
comparing to group 1.
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REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES
95 Confidence Interval for Mean 95 Confidence Interval for Mean
N Mean Std. Deviation Std. Error Lower Bound Upper Bound
1 15 188.67 20.999 5.422 177.04 200.30
2 15 234.20 31.412 8.111 216.80 251.60
3 15 273.00 26.979 6.966 258.06 287.94

ANOVA ANOVA ANOVA ANOVA ANOVA
REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES
Sum of Squares df Mean Square Sig.
Between Groups 53454.178 2 26727.089 .000
Within Groups 30177.733 42 718.517

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Post Hoc Tests
Multiple Comparisons Multiple Comparisons Multiple Comparisons Multiple Comparisons Multiple Comparisons Multiple Comparisons Multiple Comparisons
REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES LSD REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES LSD REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES LSD REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES LSD REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES LSD REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES LSD REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES LSD
(I) GROUP (J) GROUP 95 Confidence Interval 95 Confidence Interval
(I) GROUP (J) GROUP Mean Difference (I-J) Std. Error Sig. Lower Bound Upper Bound
1 2 -45.533 9.788 .000 -65.29 -25.78
1 3 -84.333 9.788 .000 -104.09 -64.58
2 1 45.533 9.788 .000 25.78 65.29
2 3 -38.800 9.788 .000 -58.55 -19.05
3 1 84.333 9.788 .000 64.58 104.09
3 2 38.800 9.788 .000 19.05 58.55
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HEMODYNAMIC VARIABLES
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Descriptives Descriptives Descriptives Descriptives Descriptives Descriptives

N Mean Std. Deviation Std. Error
SYSTOLIC 1 15 102.93 10.872 2.807
SYSTOLIC 2 15 98.00 6.928 1.789
SYSTOLIC 3 15 91.47 8.052 2.079
SYSTOLIC
DIASTOLIC 1 15 58.00 7.635 1.971
DIASTOLIC 2 15 55.60 10.802 2.789
DIASTOLIC 3 15 47.20 6.625 1.710
DIASTOLIC
BP AT 15 MIN
ANOVA ANOVA ANOVA ANOVA
F Sig.
MINIMUM BP SYSTOLIC Between Groups 6.444 .004
MINIMUM BP DIASTOLIC Between Groups 6.613 .003
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Descriptives Descriptives Descriptives Descriptives Descriptives Descriptives

N Mean Std. Deviation Std. Error
SYSTOLIC 1 15 113.67 10.795 2.787
SYSTOLIC 2 15 107.20 6.201 1.601
SYSTOLIC 3 15 102.33 5.150 1.330
SYSTOLIC
DIASTOLIC 1 15 67.20 7.183 1.855
DIASTOLIC 2 15 65.00 7.241 1.870
DIASTOLIC 3 15 58.80 4.212 1.088
DIASTOLIC
BP AT 30 MIN
ANOVA ANOVA ANOVA ANOVA
F Sig.
MEAN BP SYSTOLIC Between Groups 8.014 .001
MEAN BP DIASTOLIC Between Groups 7.011 .002
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Descriptives Descriptives Descriptives Descriptives Descriptives Descriptives
BP AT 60 MIN
N Mean Std. Deviation Std. Error
SYSTOLIC 1 15 108.56 10.795 2.787
SYSTOLIC 2 15 100.20 6.201 1.601
SYSTOLIC 3 15 96.33 5.150 1.330
SYSTOLIC
DIASTOLIC 1 15 68.20 7.183 1.855
DIASTOLIC 2 15 65.00 7.241 1.870
DIASTOLIC 3 15 52.40 4.212 1.088
DIASTOLIC
ANOVA ANOVA ANOVA ANOVA
F Sig.
MINIMUM BP SYSTOLIC Between Groups 6.444 .066
MINIMUM BP DIASTOLIC Between Groups 6.613 .002
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Descriptives Descriptives Descriptives Descriptives Descriptives Descriptives

HEART RATE N Mean Std. Deviation Std. Error
At 15 min. 1 15 77.07 9.823 2.536
At 15 min. 2 15 73.13 8.123 2.097
At 15 min. 3 15 64.47 7.210 1.862
At 15 min.
At 30 min. 1 15 89.07 9.354 2.415
At 30 min. 2 15 73.87 11.438 2.953
At 30 min. 3 15 70.80 8.833 2.281
At 30 min.
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HEART RATE N Mean Std. Deviation Std. Error
At 60 min. 1 15 85.01 12.823 2.536
At 60 min. 2 15 84.13 9.123 2.097
At 60 min. 3 15 71.36 5.210 1.862
At 60 min.
ANOVA
HEART RATE SIGNIFICANCE
15 MIN 0.001
30 MIN 0.000
60 MIN 0.004
36
RAMSEY SEDATION SCORE RAMSEY SEDATION SCORE RAMSEY SEDATION SCORE RAMSEY SEDATION SCORE RAMSEY SEDATION SCORE RAMSEY SEDATION SCORE
Score GROUP GROUP
1 2 3
1 15 3 0
1
2 11 0
2
3 1 7
3
4 0 8
4
Total Count 15 15 15
Total
P 0.000 SIGNIFICANT.
37
GROUP 1 2 3
15
11
8
7
3
1
38
RESULTS
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
CONCLUSION
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.
42
THANK YOU.
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