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Table of Content - Volume 18 Issue 2 - May 2021


Comparison of two doses of Dexmedetomidine (0.25 mcg/kg/hr versus 0.5 mcg/kg/hr) for intravenous sedation in patients undergoing Percutaneous Nephrolithotomy (PCNL) under spinal anaesthesia

 

Shweta Jain

 

Assistant Professor, Department of Anaesthesia, Ananta Institute of Medical Sciences, Rajsamand, INDIA.

Email: docpages11@gmail.com

 

Abstract              Background: The primary aim of present study is to evaluate and to compare the efficacy of two different doses of dexmedetomidine (dex) (0.25 mcg/kg/hr versus 0.5 mcg/kg/hr) in terms of hemodynamic signs and complications in patients undergoing PCNL under spinal anaesthesia. Material And Methods: It was a prospective study carried out at a tertiary healthcare center of southern Rajasthan for the period of 2 years. 120 patients undergoing PCNL under SA for renal or urinary tract calculi were included in the study and were divided into three groups on the basis of drugs used for sedation perioperatively: group A (normal saline), group B (0.25 mcg/kg dex bolus followed by 0.25 mcg/kg/hr maintenance dose) and group C (0.50 mcg/kg dex bolus followed by 0.25 mcg/kg/hr maintenance dose). Hemodynamic parameters were recorded before surgery (T0), immediately after loading dose (T1), 20 minutes after loading dose (T2), immediately after surgery (T3) and 2 hours after surgery (T4). Results: All the three groups were comparable with no statistical difference in terms of age, sex, BMI, operative time, irrigation time, irrigation fluid volume, or infusion fluid volume. The mean arterial pressure (MAP) was significantly reduced at time T1 – T4 when compared to that of T0 in all three groups. Heart rate was comparable in all the three groups at T0 with no significant differences. The SpO2 and body temperature did not differ among the three groups and also did not change significantly in any group at any time point between T0 to T4. Conclusion: The use of Dexmedetomidine was found to be associated with lower incidence of intra operative and post operative fever and hot/cold/itchy feeling to the patients without altering much the hemodynamic parameters of the patients. Patient’s acceptability was better to the procedure when Dexmedetomidine was used for sedation.

Keywords: Percutaneous nephrolithotomy, renal calculi, sedation, spinal, dexmedetomidine.

 

INTRODUCTION

Percutaneous nephrolithotomy (PCNL) was introduced in 1976 and since then it has become the treatment of choice for extracting renal and urinary calculi considering the size of calculi equal to or larger than 2 cm and staghorn calculi1,2,3. PCNL can be performed under general anaesthesia (GA) or regional anaesthesia such as spinal anaesthesia (SA)4. PCNL under GA has advantages like feasibility to control tidal volume and extensibility of anaesthesia time in case of long surgeries and comfort to the patient but SA has some advantages over GA such as low postoperative pain, less bleeding, reduce venous pressure at surgical field, low consumption of analgesic drugs and avoids side effects from multiple medication used in GA 5,6. However, SA has the disadvantage of acute hypotension which can occur due to sympathetic block7,8. PCNL procedure itself has the complications ranges from mild fever and systemic inflammatory response (SIRS) to severe sepsis9,10. Thus it is advisable to explore procedures or drugs which can be used to minimise the risks and side effects related to the procedure. Dexmedetomidine is a selective adrenergic α2 agonist. It has sedative, analgesic and anaesthetic sparing effects. It decreases heart rate, blood pressure and circulating plasma catecholamines in a dose dependent fashion11,12. Furthermore, previous studies have demonstrated that perioperative Dexmedetomidine administration is associated with low SIRS incidence13. The primary aim of present study is to evaluate and to compare the efficacy of two different doses of dexmedetomidine in terms of hemodynamic signs and complications in patients undergoing PCNL under spinal anaesthesia.

 

MATERIAL AND METHODS

The present study was a prospective study carried out in the department of anaesthesia of a tertiary healthcare center of southern Rajasthan during the period of 2 years from March 2018 to March 2020. 120 patients undergoing PCNL under SA for renal or urinary tract calculi were included in the study.

Sample size and sampling: 120 patients of renal calculi undergoing PCNL under SA

Study type: Prospective, Cohort

Duration of study: 2 years

Inclusion criteria:

  • Patients with American society of anaesthesiologists (ASA) status I or II.
  • Age ranges between 18 years to 65 years
  • Absence of pre-operative clinical infection or positive urine culture

Exclusion criteria

  • Patients with associated cardiac, CNS or other co morbidities.
  • Recent history of any renal or urinary tract surgery.
  • ASA grade ≥ 3
  • Patients who were not fit or ready for SA.
  • Patients who were not willing to participate or unable to give consent.

Intervention: all the patients were given SA in conventional manner. Under aseptic precautions, 25-gauge spinal needle was inserted at level L3-L4 space and after confirming the free flow of CSF (cerebrospinal fluid), 3 ml of 0.5% bupivacaine along with 0.5 ml fentanyl was injected. After successful administration, patients were positioned in prone position. Patients were then divided into three groups based on drugs used intraoperatively.

Group A: Normal saline was used for infusion perioperatively.

Group B: 0.25 mcg/kg Dexmedetomidine (Dex) was given as intravenous bolus followed by 0.25 mcg/kg/hr maintenance dose.

Group C: 0.5 mcg/kg Dexmedetomidine was given as intravenous bolus followed by 0.5 mcg/kg/hr maintenance dose.

Outcome assessment:

The mean arterial pressure (MAP), heart rate, arterial oxygen saturation (SpO2), body temperature, and observer’s assessment of alertness and sedation (OAA/S) scale score were recorded at the following time points: before surgery (T0), immediately after loading dose of Dex or normal saline (T1), 20 minutes after loading dose of Dex or normal saline (T2), immediately after surgery (T3) and 2 hours after surgery (T4)14.Shivering was examined during surgery, 2 hours after surgery, and 24 hours after surgery. Intraoperative adverse reactions were assessed using the Iowa Satisfaction with Anesthesia Scale15.

Ethical clearance: approval from institutional ethical committee was taken before starting the study and well informed consent was also taken from all the patients involved in the study.

Statistical analysis: all statistical analysis was performed using SPSS 19.0 software.

RESULTS

The study was performed during the period of two years from March 2018 to March 2020 and 120 patients undergoing PCNL under SA were included in the study. All the participants were divided into three groups on the basis of drugs used for sedation perioperatively: group A (normal saline), group B (0.25 mcg/kg Dexmedetomidine as bolus followed by 0.25 mcg/kg/hr maintenance dose) and group C (0.50 mcg/kg Dexmedetomidine as bolus followed by 0.25 mcg/kg/hr maintenance dose). All the three groups were comparable with no statistical difference in terms of age, sex, BMI, operative time, irrigation time, irrigation fluid volume, or infusion fluid volume (Table 1).


 

 

 

 

 

Table 1: General information of participants

S.No.

Characteristic

Group A

Group B

Group C

1

Age

52.50±9.11

52.11±8.64

53.69±10.33

2

Sex (M:F)

23:17

19:21

23:17

3

BMI

23.66±3.10

22.98±2.94

22.08±2.62

4

Operative time (minutes)

67±12.66

64±19.76

62±12.49

5

Irrigation time (minutes)

32±5.13

36±7.00

37±7.43

6

Irrigation fluid volume (Litre)

18.76±8.09

17.91±9.88

17.72±11.65

7

Infusion fluid volume (Litre)

0.76±0.21

0.72±0.13

0.69±0.10

The mean arterial pressure (MAP) was significantly reduced at time T1 – T4 when compared to that of T0 (P value< 0.05) in all three groups. However, MAP did not significantly differ among the three groups in respective time scale (p value > 0.05). (Table 2) Heart rate was comparable in all the three groups at T0 with no significant difference. However, there was significant difference in HR at time point T1-T4 when compared to T0 in group B and group C. Also, the HR in group B and group C was significantly lower than group A at time points T1-T4 (p value< 0.05). There were no significant differences in the heart rate among groups B and C at any time point. (Table 2) The SpO2 and body temperature did not differ among the three groups and also did not change significantly in any group at any time point between T0 to T4. (Table 2) The OAA/S scale score was significantly lower in group B and group C at time point T1 to T3 than that of group A (p-value <0.05). (Table 2)

 

Table 2: Intraoperative MAP, HR, arterial oxygen saturation, body temperature and OAA/s scale

 

T0

T1

T2

T3

T4

Mean Arterial Pressure (MAP)

Group A

103.44±13.21

101.38±12.29

98.54±12.64

97.97±12.51

98.92±13.11

Group B

105.21±13.98

97.70±12.75

87.77±11.09

90.43±14.11

92.01±13.19

Group C

106.37±14.01

94.86±11.66

85.88±11.51

89.07±12.69

90.67±12.82

Heart Rate (bpm)

Group A

82.52±9.81

81.65±10.02

79.87±11.00

79.87±11.00

79.87±11.00

Group B

79.45±11.43

62.85±10.87

60.99±10.76

61.21±9.76

60.45±7.77

Group C

84.44±9.66

67.49±11.74

62.09±9.52

61.70±9..92

64.00±9.79

Arterial oxygen saturation (SpO2)

Group A

98.66±1.44

98.00±1.76

98.03±1.00

97.93±1.77

98.54±1.61

Group B

97.93±1.59

97.91±1.50

97.22±1.32

96.99±1.98

98.22±1.31

Group C

97.02±1.51

96.98±1.62

97.08±1.45

96.39±1.41

97.37±1.55

Body Temperature (ºC)

Group A

36.98±0.61

37.00±0.43

36.60±0.41

36.03±0.58

36.71±0.49

Group B

37.02±0.32

36.53±0.45

36.03±0.33

35.58±0.62

36.59±0.61

Group C

37.08±0.41

36.88±0.37

36.70±0.32

36.78±0.80

37.02±0.12

OAA/S scale score

Group A

5.00±0.00

5.00±0.00

5.00±0.00

5.00±0.00

5.00±0.00

Group B

5.00±0.00

4.00±0.77

3.75±0.75

4.90±0.42

5.00±0.00

Group C

5.00±0.00

3.70±0.75

3.10±0.90

4.85±1.01

5.00±0.00

34 among 40 patients in group A suffer shivering during surgery which was significantly higher than that of group B (5 patients) and group C (5 patients). The post operative shivering rate after 2 hours and 24 hours did not differ significantly among three groups. (Table 3)

 

Table 3: Intra operative and post operative shivering in participants

 

Group A (n=40)

Group B(n=40)

Group C(n=40)

Shivering during surgery

34

5

5

Shivering 2 hours after surgery

11

4

5

Shivering 24 hours after surgery

2

0

1

Bradycardia was noted in 3 patients of group A which was significantly lower than that of group C (10 patients) (p-value <0.05) but was comparable with that of group B (5 patients). 22 among 40 patients in group A reported hot/cold/itchy feeling which was significantly higher than that of group B and C. 10 patients in the group A reported about uncomfortable position which was significantly higher than that of group B and C. Rest of the adverse reactions like hypotension and nausea/ vomiting did not differ significantly among the three groups. (Table 4)

 

Table 4: Intra operative adverse reactions noted in participants

Adverse reactions

Group A (n=40)

Group B(n=40)

Group C(n=40)

Sinus bradycardia

3

5

10

Hypotension

8

8

12

Nausea/Vomiting

10

4

6

Feeling hot/cold/itchy

22

6

3

Uncomfortable position

10

3

2

Willing to use the same mode of anaesthesia again

32

37

39

 


DISCUSSION

The present study was a prospective cohort study conducted at a tertiary care centre of southern Rajasthan during the period of two years from March 2018 to March 2020. Total 120 patients were included in the study with the mean age of 52.76 years and male female ratio of 1.18. All the 120 patients were divided into three groups depends on the type of drug used for the sedation while doing PCNL under spinal anaesthesia: group A (normal saline), group B (0.25 mcg/kg Dexmedetomidine as bolus followed by 0.25 mcg/kg/hr maintenance dose) and group C (0.50 mcg/kg Dexmedetomidine as bolus followed by 0.25 mcg/kg/hr maintenance dose). Similar study was performed by Yi Hu et al. in 2019. They included 60 patients in their study (20 in each group) with the mean age of patients similar to present study. Ratio of Male and female was 0.714 in their study which is in contrary to present study16. In present study, all the three groups were comparable with no statistical difference in terms of age, sex, BMI, operative time, irrigation time, irrigation fluid volume, or infusion fluid volume. Similar findings were reported in previous studies done by Yi Hu et al. in 2019, Fang Tan et al. in 2018 and Yingqing Deng et al. in 201716-18. In the present study, the mean arterial pressure (MAP) was significantly reduced at time T1 – T4 when compared to that of T0 (P value< 0.05) in all three groups. However, MAP did not significantly differ among the three groups in respective time scale (p value > 0.05). The results were similar to that of previous study done by Yi Hu in 2019. They found no significant differences in the MAP among the three groups at all-time points, except at T116. In another study performed by Hiroyshi Kawaii in 2010, they used two doses of Dexmedetomidine 0.2 mcg/kg/hr and 0.4 mcg/kg/hr for sedation in dental procedures. They found that after a brief increase in the MAP of both the groups following the initiation of infusion, the MAP decreased significantly from 10minutes after initiation of DEX infusion through the 60minutes post infusion time period19. In present study, there was significant difference in HR at time point T1-T4 when compared to T0 in group B and group C. Also, the HR in group B and group C was significantly lower than group A at time points T1-T4. The SpO2 and body temperature did not differ among the three groups and also did not change significantly in any group at any time point between T0 to T4. The OAA/S scale score was significantly lower in group B and group C at time point T1 to T3 than that of group A. The results were similar to the previous studies16, 18.Shivering is a common complication of spinal anaesthesia which can be worsened by continuous irrigation with large volumes of cold fluid during PCNL. Though it is a protective mechanism, shivering is usually uncomfortable to the patients and may interfere with surgical procedures and vital sign monitoring. Dexmedetomidine lowers the temperature threshold for shivering in the peripheral vessels and the central nervous system, and thus prevent shivering20. In present study, 34 among 40 patients in normal saline group suffered shivering during surgery which was significantly higher than that of Dexmedetomidine group B (5 patients) and group C (5 patients). Various adverse reactions like hypotension and nausea or vomiting were similar in all the three groups except brady cardia which was significantly higher in group B and comparatively higher in group C than that of group A. On the other hand, hot/cold/itchy feeling was significantly higher in normal saline group than Dexmedetomidine groups. The results were in support of previous studies16-19.

 

CONCLUSION

The findings of present study support the use of Dexmedetomidine for intravenous sedation in PCNL under spinal anaesthesia. The use of Dexmedetomidine was found to be associated with lower incidence of intra operative and post operative fever and hot/cold/itchy feeling to the patients without altering much the hemodynamic parameters of the patients. Patient’s acceptability was better to the procedure when Dexmedetomidine was used for sedation. However, the two doses of Dexmedetomidine (0.25 mcg/kg/hr and 0.5 mcg/kg/hr) did not differ much in providing sedation. Further clinical trials and researches are required in future to evaluate the role of Dexmedetomidine.

 

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