Dr. V.Philitsen .

MY GUIDE

PROFESSOR Dr. P.S.SHANMUGAM, M.D.,D.A

H.O.D. OF ANESTHESIOLOGY
KILPAUK MEDICAL COLLEGE
CHENNAI
 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).
 STUDY DESIGN

Prospective randomised control study

After Ethical committee approval

Pre operative assesment done for all cases

Informed consent obtained ,

 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
 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

 Drugs Used

-0.5 % Hyperbaric Bupivaccaine

-Preservative free Fentanyl

-Preservative free Clonidine

-0.9 % Normal Saline

 GROUPS

A 15 mg of 0.5% bupivaccaine(H) + 0.5ml of N.S.

B 15 mg of 0.5% bupivaccaine(H) + 25 g of Fentanyl

C 15 mg of 0.5% bupivaccaine(H) + 50 g of clonidine

corrected to a volume of 0.5ml by adding N.S.
 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.
-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
 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.
 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
 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.
 ASSESMENT OF MOTOR BLOCK
BROMAGE SCORE
Grade Criteria Degree of Block

I Free movement of legs and feet Nil (0%)

Just able to flex knees with free

II Partial (33%)
movement of feet

Unable to flex knees, but with free Almost Complete

III
movement of feet (66%)

IV Unable to move legs or feet Complete (100%)

 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

AGE

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

AGE

Sum of Squares df Mean Square Sig.

Between Groups 32.133 2 16.067 .681
Within Groups 1737.067 42 41.359
HEIGHT

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
HEIGHT

Sum of Squares df Mean Square Sig.

Between Groups 6.578 2 3.289 .912
Within Groups 1489.333 42 35.460
WEIGHT

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

WEIGHT

Sum of Squares df Mean Square Sig.

Between Groups 18.978 2 9.489 .837
Within Groups 2230.000 42 53.095
MAXIMUM SENSORY LEVEL BLOCKED

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
MAXIMUM SENSORY LEVEL BLOCKED

Sum of Squares df Mean Square Sig.

Between Groups .578 2 .289 .821
Within Groups 61.333 42 1.460
TIME TO ACHIEVE MAXIMUM SENSORY LEVEL IN MINUTES

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

Sum of Squares df Mean Square Sig.

Between Groups 248.311 2 124.156 .133
Within Groups 2460.133 42 58.575
SENSORY REGRESSION TO L1 MINUTES

95% Confidence Interval for Mean

N Mean Std. Deviation Std. Error Lower Bound Upper Bound

1 15 19.969 5.156 160.14 182.26
171.20
2 15 47.442 12.249 204.73 257.27
231.00
3 15 35.950 9.282 230.76 270.57
250.67

ANOVA
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
Post Hoc Tests
Multiple Comparisons

SENSORY REGRESSION TO L1 MINUTES

LSD

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

3 -79.467* 13.236 .000 -106.18 -52.76

2 1 59.800* 13.236 .000 33.09 86.51

3 -19.667 13.236 .145 -46.38 7.04

3 1 79.467* 13.236 .000 52.76 106.18

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.
ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES

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
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
Post Hoc Tests
Multiple Comparisons

ONSET OF GRADE 4 MOTOR BLOCK IN MINUTES

LSD

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

3 4.267* 1.105 .000 2.04 6.50

2 1 -3.133* 1.105 .007 -5.36 -.90

3 1.133 1.105 .311 -1.10 3.36

3 1 -4.267* 1.105 .000 -6.50 -2.04

2 -1.133 1.105 .311 -3.36 1.10

*. 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.
 REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES

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
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
Post Hoc Tests
Multiple Comparisons

REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTES

LSD

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

3 -84.333* 9.788 .000 -104.09 -64.58

2 1 45.533* 9.788 .000 25.78 65.29

3 -38.800* 9.788 .000 -58.55 -19.05

3 1 84.333* 9.788 .000 64.58 104.09

2 38.800* 9.788 .000 19.05 58.55

 Descriptives

BP AT 15 MIN
N Mean Std. Deviation Std. Error
SYSTOLIC 1 15 102.93 10.872 2.807
2 15 98.00 6.928 1.789
3 15 91.47 8.052 2.079

DIASTOLIC 1 15 58.00 7.635 1.971

2 15 55.60 10.802 2.789
3 15 47.20 6.625 1.710

ANOVA
F Sig.
MINIMUM BP SYSTOLIC Between Groups 6.444 .004
MINIMUM BP DIASTOLIC Between Groups 6.613 .003
 Descriptives

BP AT 30 MIN
N Mean Std. Deviation Std. Error
SYSTOLIC 1 15 113.67 10.795 2.787
2 15 107.20 6.201 1.601
3 15 102.33 5.150 1.330

DIASTOLIC 1 15 67.20 7.183 1.855

2 15 65.00 7.241 1.870
3 15 58.80 4.212 1.088

ANOVA

F Sig.
MEAN BP SYSTOLIC Between Groups 8.014 .001
MEAN BP DIASTOLIC Between Groups 7.011 .002
 Descriptives

BP AT 60 MIN

N Mean Std. Deviation Std. Error

SYSTOLIC 1 15 108.56 10.795 2.787
2 15 100.20 6.201 1.601
3 15 96.33 5.150 1.330

DIASTOLIC 1 15 68.20 7.183 1.855

2 15 65.00 7.241 1.870
3 15 52.40 4.212 1.088

ANOVA
F Sig.
MINIMUM BP SYSTOLIC Between Groups 6.444 .066
MINIMUM BP DIASTOLIC Between Groups 6.613 .002
 Descriptives

HEART RATE
N Mean Std. Deviation Std. Error
1 15 77.07 9.823 2.536
At 15 min.
2 15 73.13 8.123 2.097

3 15 64.47 7.210 1.862

1 15 89.07 9.354 2.415

At 30 min.
2 15 73.87 11.438 2.953

3 15 70.80 8.833 2.281

HEART RATE
N Mean Std. Deviation Std. Error
1 15 85.01 12.823 2.536
At 60 min.
2 15 84.13 9.123 2.097

3 15 71.36 5.210 1.862

ANOVA
HEART RATE SIGNIFICANCE
15 MIN 0.001
30 MIN 0.000
60 MIN 0.004
 RAMSEY SEDATION SCORE

Score GROUP

1 2 3

1 3 0
15

2 11 0

3 1 7

4 0 8

Total Count 15 15 15

P= 0.000 SIGNIFICANT.
 GROUP 1
2
15 3

11

8
7

1
- 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.
-Hemodynamic variables were relatively lower in
clonidine group.

-All the patients in clonidine group were well sedated.

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.

 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