dr. v.philitsen
DESCRIPTION
COMPARISON OF EFFECTS OF SPINAL ADDITIVES FENTANYL and CLONIDINE WITH HYPERBARIC BUPIVACCAINE . 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. - PowerPoint PPT PresentationTRANSCRIPT
COMPARISON OF EFFECTS OF SPINAL ADDITIVESFENTANYL AND CLONIDINE WITH HYPERBARIC BUPIVACCAINE
Dr. V.Philitsen .
MY GUIDE
PROFESSOR Dr. P.S.SHANMUGAM, M.D.,D.AH.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 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.
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
Assessment of sensory loss to pain was done by using24 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
ASSESMENT OF MOTOR BLOCK
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%)
BROMAGE SCORE
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
STATISTICAL ANALYSIS
DEMOGRAPHICDETAILS
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 .681Within 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
ANOVAHEIGHT
Sum of Squares df Mean Square Sig.
Between Groups 6.578 2 3.289 .912Within 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 .837Within Groups 2230.000 42 53.095
CLINICALPARAMETERS
MAXIMUM SENSORY LEVEL BLOCKED
95% Confidence Interval for Mean
N Mean Std. Deviation Std. Error Lower Bound Upper Bound1 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
ANOVAMAXIMUM SENSORY LEVEL BLOCKED
Sum of Squares df Mean Square Sig.
Between Groups .578 2 .289 .821Within 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 Bound1 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 .133Within 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 Bound1 15
171.2019.969 5.156 160.14 182.26
2 15231.00
47.442 12.249 204.73 257.27
3 15250.67
35.950 9.282 230.76 270.57
ANOVASENSORY REGRESSION TO L1 MINUTES
Sum of Squares df Mean Square Sig.
Between Groups 51388.844 2 25694.422 .000Within Groups 55185.733 42 1313.946
Multiple Comparisons
SENSORY REGRESSION TO L1 MINUTESLSD
(I) GROUP (J) GROUP
95% Confidence Interval
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
Post Hoc Tests
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 Bound1 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 .001Within Groups 384.667 42 9.159
Multiple Comparisons
ONSET OF GRADE 4 MOTOR BLOCK IN MINUTESLSD
(I) GROUP (J) GROUP
95% Confidence Interval
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.
Post Hoc Tests
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 Bound1 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 .000Within Groups 30177.733 42 718.517
Multiple Comparisons
REGRESSION TO GRADE 1 MOTOR BLOCK IN MINUTESLSD
(I) GROUP (J) GROUP
95% Confidence Interval
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
Post Hoc Tests
HEMODYNAMIC VARIABLES
Descriptives
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 .004MINIMUM BP DIASTOLIC Between Groups 6.613 .003
BP AT 15 MIN
Descriptives
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 .001MEAN BP DIASTOLIC Between Groups 7.011 .002
BP AT 30 MIN
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 .066MINIMUM BP DIASTOLIC Between Groups 6.613 .002
Descriptives
HEART RATE N Mean Std. Deviation Std. Error
At 15 min.1 15 77.07 9.823 2.536
2 15 73.13 8.123 2.097
3 15 64.47 7.210 1.862
At 30 min.1 15 89.07 9.354 2.415
2 15 73.87 11.438 2.953
3 15 70.80 8.833 2.281
HEART RATE N Mean Std. Deviation Std. Error
At 60 min.1 15 85.01 12.823 2.536
2 15 84.13 9.123 2.097
3 15 71.36 5.210 1.862
HEART RATE SIGNIFICANCE15 MIN 0.00130 MIN 0.00060 MIN 0.004
ANOVA
RAMSEY SEDATION SCORE
Score GROUP
1 2 3 1
15
3 0
2
11 0
3 1 7
4 0 8
Total Count 15
15 15P= 0.000 SIGNIFICANT.
GROUP 1 2 315
3
11
1
87
RESULTS
- 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.
CONCLUSIONCLONIDINE 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.
THANK YOU.
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