A COMPARATIVE CLINICAL STUDY OF INTRATHECAL DEXMEDETOMIDINE 5 mueg AND INTRATHECAL FENTANYL 25 mueg AS AN ADJUVANT WITH 0.5% HYPERBARIC BUPIVACAINE 12.5 mg IN ELECTIVE LOWER LIMB SURGERIES
Thuraganur Kapanigowda Shashikala1, Kakaraddi Sanjeev2, Gowda Ashwathappa Prathibha3, Madhystha Kavya4, Honakeri Naveen5, Velagalaburre Yalappa Srinivas6
1Associate Professor, Department of Anaesthesiology, K. R. Hospital, Mysore Medical College and Research Institute, Mysore.
2Junior Resident, Department of Anaesthesiology, K. R. Hospital, Mysore Medical College and Research Institute, Mysore.
3Junior Resident, Department of Anaesthesiology, K. R. Hospital, Mysore Medical College and Research Institute, Mysore.
4Junior Resident, Department of Anaesthesiology, K. R. Hospital, Mysore Medical College and Research Institute, Mysore.
5Junior Resident, Department of Anaesthesiology, K. R. Hospital, Mysore Medical College and Research Institute, Mysore.
6Professor, Department of Anaesthesiology, K. R. Hospital, Mysore Medical College and Research Institute, Mysore.
CORRESPONDING AUTHOR
Dr. Thuraganur Kapanigowda Shashikala,
Email : drshi72@yahoo.com
ABSTRACT
Corresponding Author:
Dr. Thuraganur Kapanigowda Shashikala,
Associate Professor,
Department of Anaesthesiology,
Stone Building, K R Hospital,
Mysore Medical College and Research Institute,
Mysore.
E-mail: drshi72@yahoo.com
ABSTRACT
BACKGROUND
Various adjuvants are being used with local anaesthetics intrathecally for prolongation of intraoperative and postoperative analgesia. Dexmedetomidine, the highly selective alpha-2 adrenergic agonist is a new neuraxial adjuvant gaining popularity. Fentanyl is commonly used as an opioid adjuvant to local anaesthetic for spinal anaesthesia.
AIM
The purpose of this study was to compare the onset, duration of sensory and motor block, haemodynamic effects, postoperative analgesia and adverse effects of dexmedetomidine and fentanyl used intrathecally with hyperbaric 0.5% bupivacaine for spinal anaesthesia.
METHODOLOGY
The study was conducted in prospective, double-blind manner. It included 90 American Society of Anaesthesiology (ASA) class I and II patients undergoing lower limb surgery under spinal anaesthesia. The patients were randomly allocated into three groups (30 patients each). Group C received 12.5 mg hyperbaric bupivacaine (2.5 mL) with normal saline (0. 5mL), group F received 12.5 mg bupivacaine (2.5 mL) with 25 µg fentanyl (0.5 mL) and group D received 12.5 mg bupivacaine (2.5 mL) plus 5 µg dexmedetomidine (0.5 mL). The onset time to reach peak sensory and motor level, the regression time of sensory and motor block, haemodynamic changes and side effects were studied.
RESULTS
Patients in Group D had significantly longer duration of sensory and motor block than patients in Group C and F. The mean time of two segment sensory block regression was 95.8±21 min in Group C, 130.5±17 in Group D, 131±22 in Group F (P<0.0001). The duration of motor block was 226±24.1, 626.5±48.5, 391.5±30.0 in Group C, D, and F respectively (P <0.0001). The onset time to reach maximum level of sensory block and modified Bromage 3 motor block were not significantly different between the groups. Dexmedetomidine group showed significantly less and delayed requirement of rescue analgesic.
CONCLUSION
Intrathecal dexmedetomidine is associated with prolonged motor and sensory block, haemodynamic stability and reduced demand of rescue analgesics as compared to fentanyl or lone bupivacaine.
KEYWORDS
Dexmedetomidine, Fentanyl, Bupivacaine Heavy, Spinal.
INTRODUCTION
Subarachnoid blockade is the most commonly used regional anaesthetic technique for lower limb surgery. Various adjuvants are being used with local anaesthetics for prolongation of intraoperative and postoperative analgesia.1
Adjuvants such as Morphine, Fentanyl, Clonidine and Dexmedetomidine have been used to supplement intrathecal local anaesthetics providing possible advantages, such as delayed onset of pain and reduced analgesic requirements.2
Dexmedetomidine, a highly selective α2 adrenergic agonist has evolved for use in critical care setting. It is also emerging as a valuable adjunct to regional anaesthesia and analgesia, where gradually evolving studies can build the evidence for its safe use in central neuraxial blocks.
Based on the earlier human studies, it is hypothesized that intrathecal 5 µg Dexmedetomidine would produce more postoperative analgesic effects with hyperbaric bupivacaine in spinal anaesthesia with minimal side effects.
Fentanyl is commonly used as an opioid adjuvant to local anaesthetic for spinal anaesthesia in our institution. A study is required to compare the traditionally used Fentanyl with recently introduced Dexmedetomidine as adjuvant to Bupivacaine intrathecal anaesthesia.
MATERIALS AND METHODOLOGY
After approval from Institutional Ethical Committee clearance, informed written consent of 90 patients aged between 30-60 years belonging to ASA class I and class II without any co-morbid conditions posted for elective lower limb surgeries.
This study population was randomly selected based on the closed sealed opaque envelop technique into
- Group-B – 12.5 mg (2.5 mL) of 0.5% hyperbaric bupivacaine with 0.5 mL normal saline.
- Group-D – 12.5 mg (2.5 mL) of 0.5% hyperbaric bupivacaine with 5 µg of Dexmedetomidine in (0.5 mL normal saline).
- Group-F – 12.5 mg (2.5 mL) of 0.5% hyperbaric bupivacaine with 25 µg of Fentanyl in (0.5 mL normal saline).
The Exclusion Criteria Includes
- Any co-morbid conditions like diabetes mellitus, asthma, hypertension, cardiac disease, haematological diseases, etc.
- Any allergy to local anaesthetics.
- Patients posted for emergency surgeries.
- Patients with body mass index more than 28 kg/m2.
- Patients having absolute contraindication for spinal anaesthesia.
All spinal blocks were given by the same anaesthesiologist who also was the observer.
Hence, the patient and the observer were blinded for the study drug.
Patients were kept nil per oral for solids 6 hours and clear fluids 2 hours before surgery.
Patients were pre-medicated on the night before surgery with the tablet Ranitidine 150 mg and tablet Alprazolam 0.5 mg.
Patients were pre-medicated just before surgery after obtaining IV line with injection Ondansetron 4 mg. Patients were preloaded with Ringer lactate 500 mL (10 mL/kg bodyweight) half an hour before anaesthesia. Patients were connected to multi-channel monitor (Starplus Larsen and Toubro Ltd., India) for monitoring Pulse Rate (PR), Arterial Oxygen Saturation (SpO2), Electrocardiograph (ECG), Non-Invasive Blood Pressure (NIBP), Mean Arterial Blood Pressure (MAP). In a sitting position under aseptic precautions, subarachnoid block was performed at L2-L3, L3-L4 interspace through a midline approach using 25-G Quincke’s spinal needle after confirming the clear and free flow of CSF and the study drug was injected into the subarachnoid space. Patients were made to lie down in supine posture, immediately supplementary oxygen was given.
The following Parameters were noted
- Onset of sensory blockade and motor blockade.
- Maximum level of sensory blockade attained and the time taken for the same.
- Time for the two segment sensory regression.
- Maximum level of motor blockade attained and the time taken for the same.
- Total duration of the sensory blockade and motor blockade.
- Total duration of analgesia.
The parameters were recorded every 30 seconds for first two minutes, every minute for next 5 minutes and every 5 minutes for next 15 minutes and every 10 minutes for the next 30 minutes and every 15 minutes till the end of the surgery and thereafter every 30 minutes until sensory blockade is resolved. The motor block was assessed according to modified Bromage scale.
Sedation was assessed by modified Ramsay sedation score at the end of the surgery. In the postoperative period, patients were monitored for the postoperative pain by VAS scale (0-10) initially every hour for 2 hours, then every 2 hours for the next 8 hours, then every 4 hours till 24 hours which was explained to the patients preoperatively. When the VAS was >4 patients were given rescue analgesia with Injection Diclofenac 75 mg intramuscularly.
Onset of Motor Blockade
Defined as the time required for the complete injection of the drug till the patient developed Bromage-1 quality of motor block.
Quality of the motor blockade will be assessed by modified Bromage scale.
- Bromage 0- No motor block.
- Bromage 1- Inability to raise the extended leg, able to move knee and feet.
- Bromage 2- Inability to raise extended leg and move knee, able to move feet.
- Bromage 3- Complete motor block of lower limb.
Time taken for the maximum motor blockade is defined as the time taken from the injection of test drug to the maximum motor blockade attained (Bromage 3).
Duration of motor blockade is defined as the time taken from the time of injection of the test drug to till the patient attains complete recovery.
Duration of analgesia is defined as the time taken from the time of injection of the test drug till the patient requests rescue analgesia in post-operative period.
Duration of the sensory blockade is defined as the time taken from the time of injection of test drug till the patients feel the sensation at S1 dermatome.
Post-operative Sedation Scoring was done as per Ramsay Sedation Scale
1= Anxious and agitated.
2= Cooperative and tranquil.
3= Drowsy but responds to commands.
4= Asleep but responds to tactile stimulation.
5= Asleep and no response.
Hypotension
Is defined as reduction in the systolic blood pressure of more than 30% below the baseline or fall in systolic blood pressure less than 90 mmHg and was treated with increased IV fluids and Injection mephentermine 6 mg IV in incremental doses.
Bradycardia
Is defined as heart rate of less than 60 beats per minute and was treated with Injection Atropine 0.6 mg IV.
Desaturation
SpO2<92% in room air.
Hypoventilation
Respiratory rate less than 10.
Adverse Effects
Like nausea, vomiting, shivering, itching, respiratory depression and hypotension were recorded.
THE RESULTS OF THE STUDY WERE STATISTICALLY ANALYSED BETWEEN THE GROUPS
Purposive Sampling was done by Using Formula,
S= z2pq/d2 where z is constant, p is prevalence, q is (1-p) and d is constant.
In this study considering hospital prevalence of 4% and confidence interval of 95%, z will be 1.96 and d will be 0.05 and applying this formula, sample size was 90 patients (30 patients in each group). The results obtained from the above study was analysed for statistical significance (p) using statistical parameters like mean, standard deviation, percentage, etc. The significance level was determined by using descriptive statistics, t-test – paired/independent samples, repeated measure ANOVA and contingency coefficient analysis using SPSS for windows (version 20.0).
Crosstabs (Contingency Table Analysis)
The Crosstabs procedure forms two-way and multi-way tables and provides a variety of tests and measures of association for two-way tables. The structure of the table and whether categories are ordered determine what test or measure to use.
Independent Samples ‘t’ Test
The Independent - Samples “t” test procedure compares means for two groups of cases. Ideally, for this test the subjects should be randomly assigned to two groups, so that any difference in response is due to the treatment (or lack of treatment) and not to other factors.
Chi-Square Test
Chi-square test (χ2 test) is a statistical test of significance for categorical variables. This test is used to test the statistical significance of the association between two categorical variables when the sample sizes are large and independent. When the sample sizes are small, i.e. if the expected frequencies are less than 5, Fisher’s exact test will be used.
Repeated Measures ANOVA
GLM repeated measures analyses groups of related dependent variables that represent different measurements of the same attribute. This dialog box lets you define one or more within-subjects factors for use in GLM repeated measures. Note that the order in which you specify within-subjects factors is important. Each factor constitutes a level within the previous factor. All the statistical calculations were done through SPSS for windows (Version 20.0).
T-Te: Control vs Dexmedetomidine
Independent Samples Test |
||||
|
t-Test for Equality of Means |
|||
t |
df |
Sig. (2-Tailed) |
Mean Difference |
|
HR Basal |
1.353 |
58 |
.181 |
4.90000 |
HR_0 |
1.234 |
58 |
.222 |
5.33333 |
HR_2 |
1.021 |
58 |
.311 |
3.56667 |
HR_4 |
.424 |
58 |
.673 |
1.30000 |
HR_6 |
1.173 |
58 |
.246 |
4.16667 |
HR_8 |
1.643 |
58 |
.106 |
5.06667 |
HR_10 |
1.149 |
58 |
.255 |
3.90000 |
HR_15 |
1.337 |
58 |
.186 |
4.23333 |
HR_20 |
2.179 |
58 |
.033 |
5.86667 |
HR_25 |
2.831 |
58 |
.006 |
6.60000 |
HR_30 |
2.346 |
58 |
.022 |
5.86667 |
HR_45 |
3.830 |
58 |
.000 |
11.10000 |
HR_60 |
2.781 |
58 |
.007 |
7.20000 |
HR_75 |
2.871 |
58 |
.006 |
6.60000 |
HR_90 |
2.309 |
58 |
.025 |
5.86667 |
HR_105 |
2.352 |
58 |
.022 |
5.33333 |
HR_120 |
3.087 |
58 |
.003 |
7.46667 |
SBP Basal |
.688 |
58 |
.494 |
2.23333 |
SBP_0 |
1.354 |
58 |
.181 |
4.23333 |
SBP_2 |
-.745 |
58 |
.459 |
-5.16667 |
SBP_4 |
-.473 |
58 |
.638 |
-3.38667 |
SBP_6 |
2.106 |
58 |
.040 |
8.63333 |
SBP_8 |
2.442 |
58 |
.018 |
8.86667 |
SBP_10 |
1.101 |
58 |
.276 |
4.30000 |
SBP_15 |
1.979 |
58 |
.053 |
7.86667 |
SBP_20 |
2.968 |
58 |
.004 |
10.76667 |
SBP_25 |
3.072 |
58 |
.003 |
10.23333 |
SBP_30 |
2.928 |
58 |
.005 |
11.26667 |
SBP_45 |
2.934 |
58 |
.005 |
10.76667 |
SBP_60 |
2.706 |
58 |
.009 |
8.46667 |
SBP_75 |
2.221 |
58 |
.030 |
6.30000 |
SBP_90 |
2.740 |
58 |
.008 |
7.96667 |
SBP_105 |
2.801 |
58 |
.007 |
8.66667 |
SBP_120 |
2.739 |
58 |
.008 |
8.43333 |
DBP Basal |
.113 |
58 |
.911 |
.26667 |
DBP_0 |
1.061 |
58 |
.293 |
2.13333 |
DBP_2 |
2.185 |
58 |
.033 |
4.53333 |
DBP_4 |
1.335 |
58 |
.187 |
2.83333 |
DBP_6 |
1.817 |
58 |
.074 |
5.00000 |
DBP_8 |
2.319 |
58 |
.024 |
6.33333 |
DBP_10 |
.666 |
58 |
.508 |
2.00000 |
DBP_15 |
1.113 |
58 |
.270 |
2.50000 |
DBP_20 |
3.154 |
58 |
.003 |
6.23333 |
DBP_25 |
2.669 |
58 |
.010 |
5.36667 |
DBP_30 |
2.067 |
58 |
.043 |
4.90000 |
DBP_45 |
2.239 |
58 |
.029 |
5.33333 |
DBP_60 |
2.935 |
58 |
.005 |
5.00000 |
DBP_75 |
1.964 |
58 |
.054 |
3.36667 |
DBP_90 |
2.454 |
58 |
.017 |
3.73333 |
DBP_105 |
1.417 |
58 |
.162 |
2.56667 |
DBP_120 |
1.627 |
58 |
.109 |
2.26667 |
MAP Basal |
1.001 |
58 |
.321 |
2.56667 |
MAP_0 |
2.055 |
58 |
.044 |
4.46667 |
MAP_2 |
2.830 |
58 |
.006 |
6.40000 |
MAP_4 |
1.678 |
58 |
.099 |
4.13333 |
MAP_6 |
2.221 |
58 |
.030 |
6.90000 |
MAP_8 |
2.826 |
58 |
.006 |
7.83333 |
MAP_10 |
.969 |
58 |
.337 |
3.16667 |
MAP_15 |
2.018 |
58 |
.048 |
5.83333 |
MAP_20 |
3.110 |
58 |
.003 |
8.10000 |
MAP_25 |
3.360 |
58 |
.001 |
8.53333 |
MAP_30 |
2.887 |
58 |
.005 |
6.86667 |
MAP_45 |
3.018 |
58 |
.004 |
8.86667 |
MAP_60 |
3.054 |
58 |
.003 |
7.03333 |
MAP_75 |
2.472 |
58 |
.016 |
5.16667 |
MAP_90 |
2.934 |
58 |
.005 |
5.93333 |
MAP_105 |
1.717 |
58 |
.091 |
3.86667 |
MAP_120 |
2.848 |
58 |
.006 |
5.20000 |
Table 1 |
T-Test
Independent Samples Test |
||||
|
t-Test for Equality of Means |
|||
t |
df |
Sig. (2-Tailed) |
Mean Difference |
|
Sen_para TOSB |
-1.680 |
58 |
.098 |
-.20000 |
TOMLSB |
-2.483 |
58 |
.016 |
-.53333 |
TTSSB |
-6.922 |
58 |
.000 |
-34.66667 |
TCSR |
-41.797 |
58 |
.000 |
-398.33333 |
TDA |
-40.476 |
58 |
.000 |
-400.50000 |
TRA |
-40.725 |
58 |
.000 |
-416.50000 |
TOMB |
-.918 |
58 |
.362 |
-.13333 |
TDMB |
-22.509 |
58 |
.000 |
-276.00000 |
Table 2 |
Notes |
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Output Created |
21-APR-2016 08:10:08 |
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Comments |
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Input |
Data |
C:\Users\user\Desktop\med\Dr Prathibha 3grp.sav |
Active Dataset |
DataSet 1 |
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Filter |
<none> |
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Weight |
<none> |
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Split File |
<none> |
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N of Rows in Working Data File |
60 |
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Missing Value Handling |
Definition of Missing |
User-defined missing values are treated as missing. |
Cases Used |
Statistics for each table are based on all the cases with valid data in the specified range(s) for all variables in each table. |
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Syntax |
CROSSTABS /TABLES=MLSB Bradycardia Hypotension BY Grp /FORMAT=AVALUE TABLES /STATISTICS=PHI /CELLS=COUNT COLUMN /COUNT ROUND CELL |
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Resources |
Processor Time |
00:00:00.00 |
Elapsed Time |
00:00:00.00 |
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Dimensions Requested |
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Cells Available |
174762 |
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Table 3 |
Maximum Level Sensory Block * Group
Crosstab |
|||||
|
Grp |
Total |
|||
Cont |
Dexem |
||||
MLSB |
T6 |
Count |
9 |
8 |
17 |
% within Grp |
30.0% |
26.7% |
28.3% |
||
T8 |
Count |
7 |
11 |
18 |
|
% within Grp |
23.3% |
36.7% |
30.0% |
||
T10 |
Count |
12 |
11 |
23 |
|
% within Grp |
40.0% |
36.7% |
38.3% |
||
T12 |
Count |
2 |
0 |
2 |
|
% within Grp |
6.7% |
0.0% |
3.3% |
||
Total |
Count |
30 |
30 |
60 |
|
% within Grp |
100.0% |
100.0% |
100.0% |
||
Table 4 |
Bradycardia Group
Crosstab |
|||||
|
Grp |
Total |
|||
Cont |
Dexem |
||||
Bradycardia |
Prs |
Count |
2 |
1 |
3 |
% within Grp |
6.7% |
3.3% |
5.0% |
||
Abs |
Count |
28 |
29 |
57 |
|
% within Grp |
93.3% |
96.7% |
95.0% |
||
Total |
Count |
30 |
30 |
60 |
|
% within Grp |
100.0% |
100.0% |
100.0% |
||
Table 5 |
Hypotension Group
Crosstab |
|||||
|
Grp |
Total |
|||
Cont |
Dexem |
||||
Hypotension |
Prs |
Count |
6 |
9 |
15 |
% within Grp |
20.0% |
30.0% |
25.0% |
||
Abs |
Count |
24 |
21 |
45 |
|
% within Grp |
80.0% |
70.0% |
75.0% |
||
Total |
Count |
30 |
30 |
60 |
|
% within Grp |
100.0% |
100.0% |
100.0% |
||
Table 6 |
T-Test: Control vs Fentanyl
t- Test for Equality of Means |
||||
t |
df |
Sig. (2-Tailed) |
Mean Difference |
|
HR Basal |
-1.083 |
58 |
.283 |
-5.66667 |
HR_0 |
-.577 |
58 |
.566 |
-3.16667 |
HR_2 |
-.979 |
58 |
.332 |
-5.10000 |
HR_4 |
-.919 |
58 |
.362 |
-4.13333 |
HR_6 |
-1.029 |
58 |
.308 |
-5.00000 |
HR_8 |
-.965 |
58 |
.338 |
-4.60000 |
HR_10 |
-.746 |
58 |
.459 |
-3.83333 |
HR_15 |
-1.022 |
58 |
.311 |
-4.93333 |
HR_20 |
-.538 |
58 |
.592 |
-2.36667 |
HR_25 |
.176 |
58 |
.861 |
.73333 |
HR_30 |
.589 |
58 |
.558 |
2.36667 |
HR_45 |
1.299 |
58 |
.199 |
5.40000 |
HR_60 |
.287 |
58 |
.775 |
1.16667 |
HR_75 |
.916 |
58 |
.363 |
3.10000 |
HR_90 |
.285 |
58 |
.776 |
1.00000 |
HR_105 |
.292 |
58 |
.771 |
1.06667 |
HR_120 |
.037 |
58 |
.970 |
.13333 |
SBP Basal |
-2.758 |
58 |
.008 |
-9.90000 |
SBP_0 |
-2.677 |
58 |
.010 |
-8.43333 |
SBP_2 |
-2.082 |
58 |
.042 |
-14.36667 |
SBP_4 |
-1.706 |
58 |
.093 |
-12.28667 |
SBP_6 |
-.898 |
58 |
.373 |
-3.50000 |
SBP_8 |
-.218 |
58 |
.828 |
-.76667 |
SBP_10 |
-.253 |
58 |
.801 |
-1.03333 |
SBP_15 |
.129 |
58 |
.898 |
.50000 |
SBP_20 |
1.006 |
58 |
.319 |
3.53333 |
SBP_25 |
.651 |
58 |
.517 |
2.33333 |
SBP_30 |
.073 |
58 |
.942 |
.26667 |
SBP_45 |
.303 |
58 |
.763 |
1.10000 |
SBP_60 |
.341 |
58 |
.734 |
1.10000 |
SBP_75 |
-.086 |
58 |
.932 |
-.26667 |
SBP_90 |
.078 |
58 |
.938 |
.23333 |
SBP_105 |
.042 |
58 |
.967 |
.13333 |
SBP_120 |
.331 |
58 |
.742 |
1.13333 |
DBP Basal |
-2.430 |
58 |
.018 |
-6.40000 |
DBP_0 |
.199 |
58 |
.843 |
.80000 |
DBP_2 |
-.962 |
58 |
.340 |
-2.56667 |
DBP_4 |
-.745 |
58 |
.459 |
-1.76667 |
DBP_6 |
-1.726 |
58 |
.090 |
-5.23333 |
DBP_8 |
-.628 |
58 |
.533 |
-1.76667 |
DBP_10 |
-2.078 |
58 |
.042 |
-6.33333 |
DBP_15 |
-1.284 |
58 |
.204 |
-3.33333 |
DBP_20 |
-.280 |
58 |
.781 |
-.66667 |
DBP_25 |
-.382 |
58 |
.704 |
-.96667 |
DBP_30 |
-.652 |
58 |
.517 |
-1.86667 |
DBP_45 |
-1.019 |
58 |
.312 |
-2.60000 |
DBP_60 |
-1.646 |
58 |
.105 |
-3.83333 |
DBP_75 |
-1.774 |
58 |
.081 |
-4.20000 |
DBP_90 |
-1.134 |
58 |
.261 |
-2.30000 |
DBP_105 |
-.464 |
58 |
.644 |
-.90000 |
DBP_120 |
-.506 |
58 |
.615 |
-.83333 |
MAP Basal |
-2.672 |
58 |
.010 |
-7.83333 |
MAP_0 |
-1.673 |
58 |
.100 |
-3.90000 |
MAP_2 |
-.873 |
58 |
.386 |
-2.23333 |
MAP_4 |
-.805 |
58 |
.424 |
-2.13333 |
MAP_6 |
-1.392 |
58 |
.169 |
-4.40000 |
MAP_8 |
-.412 |
58 |
.682 |
-1.13333 |
MAP_10 |
-1.475 |
58 |
.146 |
-4.90000 |
MAP_15 |
-.532 |
58 |
.597 |
-1.60000 |
MAP_20 |
.146 |
58 |
.884 |
.40000 |
MAP_25 |
.242 |
58 |
.810 |
.70000 |
MAP_30 |
-.403 |
58 |
.688 |
-1.10000 |
MAP_45 |
-.022 |
58 |
.982 |
-.06667 |
MAP_60 |
-1.000 |
58 |
.321 |
-2.73333 |
MAP_75 |
1.233 |
58 |
.223 |
5.70000 |
MAP_90 |
-.771 |
58 |
.444 |
-1.80000 |
MAP_105 |
-.057 |
58 |
.954 |
-.13333 |
MAP_120 |
.170 |
58 |
.865 |
.36667 |
Table 7 |
RESULTS
|
Group C (n=30) |
Group D (n=30) |
Group F (n=30) |
p value |
Age(Years) |
37.6±12.7 |
35.7±11.8 |
35.7±11.8 |
0.73 |
Weight(Kg) |
61.8±7.8 |
62.1±6.9 |
62.1±6.9 |
0.99 |
Height(cms) |
164.5±7.2 |
165±8.8 |
165±8.8 |
0.96 |
SEX (M:F) |
21:9 |
19:11 |
19:11 |
0.821 |
Table 8: Demographic Data, Values are the Mean±Standard deviation M=Male, F=Female, C=Control, D=Dexmedetomidine, F=Fentanyl |
Variable (min) |
Group C |
Group D |
Group F |
P value |
Time of onset of sensory block |
2.03±0.413 |
2.23±0.504 |
2.10±0.607 |
0.314 |
Time of onset of motor block |
2.2±0.504 |
2.3±0.614 |
2.2±0.406 |
0.419 |
Time to reach maximum level of sensory block (T6) |
4.3±0.844 |
4.8±0.819 |
5.4±1.357 |
0.000 |
Time of rescue analgesia |
235.5±25.675 |
652±49.785 |
394±28.987 |
0.000 |
Time for sensory regression by two segments |
95.8±21.33 |
130.5±17.238 |
131.5±22.748 |
0.000 |
Duration of sensory block |
226±24.154 |
626.5±48.515 |
391.5±30.854 |
0.000 |
Duration of motor block |
158±20.744 |
434±63.874 |
292±24.835 |
0.000 |
Table 9: Characteristics of Spinal Block |
Data shown are shown in mean±standard deviation.
Adverse Effect |
Group-C |
Group-D |
Group-F |
|
|||
No. of Pts |
Percentage |
No. of Pts |
Percentage |
No. of Pts |
Percentage |
P value |
|
Bradycardia |
2 |
6.7% |
1 |
3.3% |
0 |
0.0% |
0.355 |
Hypotension |
6 |
20.0% |
9 |
30.0% |
1 |
3.3% |
0.024 |
Vomiting |
0 |
0% |
0 |
0% |
0 |
0.0% |
0.006 |
Pruritus |
0 |
0% |
0 |
0% |
0 |
0% |
0.006 |
Hypoventilation |
0 |
0% |
0 |
0% |
0 |
0% |
0.006 |
Desaturation |
0 |
0% |
0 |
0% |
0 |
0% |
0.006 |
Table 10: Adverse Effects |
NS- Not Statistically Significant
In our study there was no statistically significant difference in the adverse effects except hypotension throughout the procedure when group D and group F were compared with group C and there was no statistically significant difference when group D was compared with group F. There were 6 patients in group C, 9 patients in group D and 1 patient in group F developed hypotension which was managed with injection mephentermine 6 mg intravenously in incremental dosage.
DISCUSSION
Hypothesis Done Before the Study
We hypothesised that Dexmedetomidine when added as an adjuvant to 0.5% hyperbaric Bupivacaine intrathecally would produce a prolonged duration of sensory blockade, motor blockade and duration of analgesia when compared to Fentanyl added as an adjuvant.
Demographic Data
In our study there was no significant difference among the three groups, i.e. Control group, Dexmedetomidine group and Fentanyl group regarding the age, height and weight of the patients.
We also did not find any statistically significant difference regarding the mean duration of surgery.
In our study, the mean time taken for the onset of sensory block was 2.03±0.413, 2.23± 0.504, 2.10±0.607 min in group C, group D and group F respectively. There was no statistically significant difference in onset time of sensory blockade among the groups (p >0.314).
Our study compared with the study conducted by Mahendru V et al3, who have also found statistically there was no significant difference in the mean onset of sensory block group BS (Bupivacaine+saline) 7.8±1.8, group BF (Bupivacaine+Fentanyl) 8.6±1.5, group BC (Bupivacaine+Clonidine) 8.3±2.8, group BD (Bupivacaine+Dexmedetomidine) 8.3±2.4 with p<0.113.
Our study also compared with SL Solanki et al4, Al-Ghanem SM et al5, Gupta R et al6 and Khan AL et al7, wherein the authors of these studies have not found any significant difference in the onset of sensory block in both Dexmedetomidine group and Fentanyl group.
In our study, subarachnoid block was given in sitting posture and then patients were positioned in supine posture soon after the completion of the subarachnoid injection.
In our study, mean time taken for maximum level of sensory blockade was 4.3±0.844, 4.8±0.819, 5.4±1.357 min in group C, group D, group F respectively (p<0.000). There was statistically significant difference among the groups. Our study compared with Singh et al8, they have found statistically significant difference among the group C and group B. In their study, the concentration of the drug used was 0.75% Bupivacaine instead of 0.5% Bupivacaine unlike our study.
In our study, maximum level of sensory blockade was not significant statistically. Our results were comparable with Mahendru V et al3, Al-Ghanem SM et al5, Gupta R et al6, Tarbeeh GA et al.9 They have also not found statistically significant difference between dexmedetomidine and fentanyl group. In our study, mean time taken for the sensory regression by two segments 95.8±21.3, 130±17.238, 131±22.748 min in group C, group D, group F respectively. p<0.000. Statistically, there was significant increase in mean time taken for two segment sensory regression in group D in group F as compared to group C.
Statistically, there was significant increase in time taken for sensory regression in group F when compared to group D. Our study compared with the study conducted by Gupta R et al6, the mean time taken for the sensory regression by two segments in group D 120±22.2 mins, group F 76±20.2 mins. The reason probably is the maximum level of sensory blockade in their study with Fentanyl group was T6 when compared to our study (T4). Our study also compared with Kanazi et al10, Khan AL et al7, Singh et al8, studies who also found significant difference in Dexmedetomidine group and fentanyl group than control group.
In our study the mean duration of rescue analgesia 235±25.675, 652±49.785, 394±28.987 in group C, group D, group F respectively. Statistically significant difference between group D compared to group F and group C and statistically significant in group F compared to group C. Our study is compared with Solanki SL et al4 study; in that they found group D 824±244, group C 678±178, group B 406±119 mins, which was statistically significant in group D and group C when compared to B. We also compared with Mahendru V et al3 study; in their study they also noticed statistically significant duration of rescue analgesia in group D when compared to group F and C. We also compared our study with Gupta R et al6; they also found significant increase in analgesia in dexmedetomidine group.
In our study time taken for onset of motor blockade 2.2±0.50 4 min, 2.3±0.614, 2.2±0.406 in group C, group D, group F respectively; p >0.419 which was not statistically significant.
In our study, the duration of motor blockade was 158±20.744, 434±63.874, 292±24.835 mins in group C, group D, group F respectively; p <0.000. Statistically, there was significant increase in mean duration of motor blockade in Group-D and Group-F as compared to Group-C. Statistically, there was significant increase in mean duration of motor blockade in Group-D as compared to Group-F. Our study compares with the study conducted by Tarbeeh GA et al9, who also found statistically significant difference in mean time taken for duration of motor blockade between Dexmedetomidine group and Fentanyl group compared with Bupivacaine group.
In our study, mean duration of motor blockade was prolonged in Group-D and statistically significant compared with Group-F. Our study compares with studies conducted by Al-Ghanem SM et al5, Gupta R et al6, Mahendru V et al3 and Tarbeeh GA et al9, who also have found statistically significant difference when Dexmedetomidine group was compared with Fentanyl group.
In our study, the mean duration of motor blockade was prolonged in Fentanyl group compared with Bupivacaine group. Our study compares with the study conducted by Mahendru V et al3, who also found statistically significant difference (Bupivacaine group - 161±19 min and Fentanyl group - 196±26 min).
In our study, mean sedation score was assessed using Ramsay sedation scale. There was no statistical significant difference among the groups (p=0.155).
Our study compares with the studies conducted by Mahendru V et al3, who also found no statistical significant difference among three groups.
In our study, there was no statistically significant difference in the haemodynamic parameters like heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure throughout the surgery when Group-D and Group-F was compared with Group-C and also there is no statistical significant difference when Group-D compared with Group-F.
In our study, there was no statistically significant difference in the adverse effects throughout the procedure when Group-D and Group-F compared with group-C and also there was no statistical significant difference when Group-D was compared with Group-F.
CONCLUSION
From the present study, we conclude that both Fentanyl and Dexmedetomidine will delay the onset of sensory and motor block, prolong the time of regression by two segments, prolong the duration of sensory block, motor block and duration of analgesia compared to bupivacaine alone.
However, Dexmedetomidine as an adjuvant produces more prolonged duration of sensory block and motor block and duration of analgesia compared to Fentanyl as an adjuvant.
Both Fentanyl and Dexmedetomidine as adjuvants do not produce significant haemodynamic changes with minimal effects on ventilation and oxygenation. They produce lesser incidence of pruritus and postoperative nausea and vomiting. Hence, it is concluded that Dexmedetomidine is better than Fentanyl as an adjuvant to 0.5% hyperbaric bupivacaine for spinal anaesthesia.
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