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Year : 2016 Month : June Volume : 5 Issue : 49 Page : 3155-3161

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

  1. Any co-morbid conditions like diabetes mellitus, asthma, hypertension, cardiac disease, haematological diseases, etc.
  2. Any allergy to local anaesthetics.
  3. Patients posted for emergency surgeries.
  4. Patients with body mass index more than 28 kg/m2.
  5. 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

  1. Onset of sensory blockade and motor blockade.
  2. Maximum level of sensory blockade attained and the time taken for the same.
  3. Time for the two segment sensory regression.
  4. Maximum level of motor blockade attained and the time taken for the same.
  5. Total duration of the sensory blockade and motor blockade.
  6. 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

Output Created

21-APR-2016 08:10:08

Comments

 

Input

Data

C:\Users\user\Desktop\med\Dr Prathibha 3grp.sav

Active Dataset

DataSet 1

Filter

<none>

Weight

<none>

Split File

<none>

N of Rows in Working Data File

60

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.

Syntax

CROSSTABS

/TABLES=MLSB Bradycardia Hypotension BY Grp

/FORMAT=AVALUE TABLES

/STATISTICS=PHI

/CELLS=COUNT COLUMN

/COUNT ROUND CELL

Resources

Processor Time

00:00:00.00

Elapsed Time

00:00:00.00

Dimensions Requested

2

Cells Available

174762

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.

REFERENCES

  1. Cousins MJ. Neural blockade in clinical anaesthesia and pain medicine. 4th edn. Philadelphia: Lippincott Williams and Wilkins 2009:p 213.
  2. Corby MP, Bach AB. Transient radicular irritation (TRI) after spinal anaesthesia in day-care surgery. Acta Anaesthesiol Scand 1998;42(4):425-9.
  3. Mahendru V, Tewari A, Katyal S, et al. A comparison of intrathecal dexmedetomidine, clonidine, and fentanyl as adjuvants to hyperbaric bupivacaine for lower limb surgery: a double blind controlled study. J Anaesthesiol Clin Pharmacol 2013;29(4):496-502.
  4. Solanki SL, Bharti N, Batra YK, et al. The analgesic effect of intrathecal dexmedetomidine or clonidine, with bupivacaine, in trauma patients undergoing lower limb surgery: a randomised, double-blind study. Anaesth Intensive Care 2013;41(1):51-6.
  5. Al-Ghanem SM, Massad IM, Al-Mustafa MM, et al. Effect of adding dexmedetomidine versus fentanyl to intrathecal bupivacaine on spinal block characteristics in gynaecological procedure: a double blind controlledstudy. American Journal of Applied Science 2009;6(5):882-7.
  6.  Gupta R, Verma R, Bogra J, et al. A comparative study of intrathecal dexmedetomidine and fentanyl as adjuvants to Bupivacaine. Journal of Anaesthesiol Clinical Pharmacolol 2011;27(3):339-43.
  7. Khan AL, Singh RB, Tripathi RK, et al. A comparative study between intrathecal dexmedetomidine and fentanyl as adjuvant to intrathecal bupivacaine in lower abdominal surgeries: a randomized trial. Anaesthesia: Essays and Researches 2015;9(2):139-48.
  8. Singh R, Shukla A. Randomized, controlled study to compare the effect of intrathecal clonidine and dexmedetomidine on sensory analgesia and motor block of hyperbaric bupivacaine. Indian Journal of Fundamental and Applied Life Sciences 2012;2(4):24-33.
  9. Tarbeeh GA, Mohamed AA. Effect of intrathecal bupivacaine-fentanyl versus bupivacaine dexmedetomidine in diabetic patients. Egyptian Journal of Anaesthesia 2013;29(1):13-8.
  10. Kanazi GE, Aouad MT, Jabbour-Khoury SI, et al. Effect of low-dose dexmedetomidine or clonidine on the characteristics of bupivacaine spinal block. Acta Anaesthesiol Scand 2006;50(2):222-7.

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