COMPARISON OF EFFICACY OF DEXMEDETOMIDINE AND TRAMADOL FOR PROPHYLACTIC USE IN POST SPINAL ANAESTHESIA SHIVERING. A PROSPECTIVE RANDOMIZED CONTROLLED STUDY
HTML Full TextCOMPARISON OF EFFICACY OF DEXMEDETOMIDINE AND TRAMADOL FOR PROPHYLACTIC USE IN POST SPINAL ANAESTHESIA SHIVERING. A PROSPECTIVE RANDOMIZED CONTROLLED STUDY
J. Mahor, R. Godwin, M. Setiya, T. Garg * and R. Mehani
Department of Pharmacology, People’s College of Medical Sciences& RC, Bhopal, Madhya Pradesh, India.
ABSTRACT: Background: Shivering is one of the most troublesome and distressing experiences for the patient encountered intraoperatively following spinal anaesthesia. Tramadol is very commonly used in clinical practice for post-spinal shivering but has side effects. The study aimed to compare the efficacy of dexmedetomidine with that of tramadol for prophylactic use in post-spinal anaesthesia shivering. Methods: A prospective, randomised controlled study was conducted on 210patients (American Society of Anaesthesiologists class I and II) of either gender, aged between 18 and 65, scheduled for elective lower abdominal and lower limb surgeriesunder spinal anaesthesia. The patients were randomized into three groups of 70 patients each. Group D received dexmedetomidine (0.5 µg/kg in 100 ml NS), Group T received tramadol (0.5 mg/kg in 100 ml NS) and Group C received 100 ml NS. All the drugs were given as an infusion over 10 min.The incidence and severity of shivering were recorded at 0min, 5min, 10min, 15 min and then every 15min till the end of surgery. The data was analyzed using IBMSPSS20 for windows. Results: The present study showed that dexmedetomidine and tramadol effectively prevent post-anaesthesia shivering, though the incidence was significantly less with dexmedetomidine (p value = 0.001). Conclusion: Dexmedetomidine is effective and comparably better than tramadol for prophylaxis of post-spinal anaesthesia. It also provides sedation without respiratory depression.
Keywords: Dexmedetomidine, Tramadol, Post-spinal anaesthesia, Shivering
INTRODUCTION: Shivering is the involuntary, mechanical, and repetitive activity of skeletal
muscles which occurs due to thermaldys regulation as a compensatory mechanism in patients receiving anaesthesia 1. Shivering is one of the most troublesome and distressing experiences for the patient encountered intraoperatively following spinal anaesthesia 2. Multiple mechanisms are suggested to explain the occurrence of shivering such as inhibition of central thermoregulation or inhibition of the autonomic vasoconstrictive tone in the lower half of the body after spinal anaesthesia leading to redistribution of core temperature to the peripheral tissues and then to the environment leading to hypothermia 3.
It causes several undesirable physiologic consequences, including increased oxygen consumption, increased CO2 production and increased minute ventilation leading to arterial hypoxemia, lactic acidosis and increased intraocular and intracranial pressure 4. In pharmacological methods, many drugs such as opioids, α2agonists, anticholinergics, central nervous system stimulants, and corticosteroids have been shown to be effective for the prevention and treatment of perioperative shivering 1. Tramadol, which is commonly used in the treatment of post anaesthesia shivering, causes nausea and vomiting 5. Dexmedetomidine α2 adrenergic agonist decreases vasoconstriction and the incidences of post anaesthesia shivering 6.
MATERIAL AND METHODS: This study was conducted in the department of Anaesthesiology at NSCB Medical College and Hospital, Jabalpur. It was a prospective, randomized control study.
American Society of Anaesthesiologists (ASA) class I and II patiens of either sex, aged between 18-65 years scheduled for elective lower abdominal and lower limb surgeries under spinal anaesthesia were recruited. Prior ethical permission was taken from the institutional ethics committee along with the review board. Written informed consent was taken from all recruited patients.
For this study, 210 patients were recruited and randomly allocated into three groups. Each group was allotted 70 patients using random allocation software. Group D patients received Dexmedetomidine (0.5mcg/kg in 100ml NS as an infusion over 10 min before subarachnoid block), Group T patients received Tramadol (0.5 mg /kg in 100 ml NS as an infusion over 10 min before subarachnoid block) and Group C patients received 100ml NS as an infusion before the subarachnoid block.
Patients with a history of hypersensitivity with Dexmedetomidine and Tramadol, drug and alcohol abuse, cardiovascular disorders, psychological disorders, and neurological disorders, thyroid disorders, bleeding diathesis, and patients with core body temperature more than 38°C or <36°C were excluded from the study.
After a thorough pre-anaesthetic check-up and fitness approval, the patients were randomly divided into three groups on the day of surgery. The study drugs were given to the patients 10 min before the subarachnoid block.
A volume of 3ml (15mg) of hyperbaric Bupivacaine 0.5% was injected using a 25 G Quincke spinal needle while the patient was in sitting position. After the subarachnoid block, patients were repositioned supine, and oxygen at a flow rate of 5 l/min was started via Hudson mask.
All parameters were measured immediately after subarachnoid block and then at 5 min, 10 min, 15 min and then every 15 min till the end of surgery. Motor block was assessed using a Modified Bromagescale 7. Assessment of the level of sensory block was evaluated by loss of sensation to pin-prick method.
Shivering was assessed and graded on ascalesimilarto that validated by Tsai and Chu.
- No shivering.
- Piloerection or Peripheral vasoconstriction but no visible shivering, visible muscular activity inonlyone muscle
- Muscular activity in morethanone muscle group but not generalized.
- Gross muscular activity involving the whole body.
The incidence and severity of shivering were recorded at 0 min, 5 min, 10 min, 15 min, and then every 15 min till the end of surgery.
Any side effects like hypotension, bradycardia, nausea and vomiting, and sedation if happened, were recorded and managed accordingly.
Statistical Analysis: The data of the present study was entered in the Microsoft Excel 2011 worksheet and after its proper validation and check for errors, resolving inconsistencies and illogical entries, coding & decoding were compiled and analyzed with the help of IBMSPSS20 for windows.
Flow Chart in the Study:
RESULTS: In our study, the mean age of patients in Group C, Group D and Group T were 33.07, 41.31 and 38.46, respectively Fig. 1.
FIG. 1: DEMOGRAPHIC DATA (AGE IN YEARS)
There was no statistically significant difference between the groups in respect to all pre-op vitals (p-value > 0.05) except respiratory rate (p-value = 0.006) Table 1.
There was no statistically significant difference between the groups in respect to all post-op vitals (p-value > 0.05) except Systolic BP (p-value = 0.003) Table 2. In the present study, there was a significant mean difference in HR and SBP in all the groups between pre-op and post-op vitals Table 3.
The incidence of shivering who had undergone surgery under spinal anesthesia was 22 (31.4%) patients in group C, 5 (7.1%) patients in group D and 10(14.3%) patients in group T (p value= 0.001). The result was statistically significant with the lowest incidence of shivering observed in group D Fig. 2, Table 4.
TABLE 1: DEMOGRAPHIC DATA (PRE-OP VITALS)
Pre-Opvitals | Group | Mean±SD | Pvalue |
HR |
C | 72.41±11.855 | 0.223 |
D | 73.4± 9.287 | ||
T | 75.67±12.669 | ||
SBP |
C | 129.43±10.591 | 0.113 |
D | 131.29± 14.478 | ||
T | 127±10.892 | ||
DBP |
C | 66.43±10.949 | 0.885 |
D | 66.09±8.997 | ||
T | 66.94±6.941 | ||
SPO2 |
C | 96.64±1.642 | 0.102 |
D | 96.4± 1.959 | ||
T | 95.94±2.232 | ||
RR |
C | 15.53±1.932 | 0.006 |
D | 14.56±2.211 | ||
T | 15.49±1.894 |
HR – Heart Rate, SBP – Systolic Blood Pressure, DSP – Diastolic Blood Pressure, RR – Respiratory rate.
TABLE 2: DEMOGRAPHIC DATA (POST-OP VITALS)
Post-Opvitals | Study Group | Mean±SD | P-value |
HR |
C | 69.01±7.711 | 0.097 |
D | 67.91±10.662 | ||
T | 71.59±11.923 | ||
SBP |
C | 119.43±13.021 | 0.003 |
D | 113.19±11.456 | ||
T | 115.31±7.756 | ||
DBP |
C | 67.50±12.298 | 0.293 |
D | 64.61±10.871 | ||
T | 65.30±10.829 | ||
SPO2 |
C | 96.53±1.631 | 0.736 |
D | 96.31±1.593 | ||
T | 96.46±1.717 | ||
RR |
C | 14.71±1.505 | 0.423 |
D | 15.03±2.014 | ||
T | 14.71±1.298 |
HR – Heart Rate, SBP – Systolic Blood Pressure, DSP – Diastolic Blood Pressure, RR – Respiratory rate.
TABLE 3: MEAN DIFFERENCE BETWEEN PRE-OP VITALS AND POST-OP VITALS
GROUP | Paired Differences (Mean±SD) | T | p | |
C | HR | 3.400±11.886 | 2.393 | .0190* |
SBP | 9.725±14.640 | 5.518 | .0000* | |
DBP | -1.071± 14.760 | -.607 | .5460 | |
SPO2 | .114 ±2.657 | .360 | .7200 | |
D | RR | .814 ±2.561 | 2.660 | .0100* |
HR | 5.486±11.229 | 4.062 | 0.0000* | |
SBP | 18.100±14.619 | 10.359 | 0.0000* | |
DBP | 1.471±12.779 | .963 | 0.3390 | |
SPO2 | 0.086±2.125 | 0.338 | 0.7370 | |
T |
RR | -0.471± 3.771 | -1.046 | 0.2990 |
HR | 4.086±10.155 | 3.366 | 0.0010* | |
SBP | 11.686±12.705 | 7.696 | 0.0000* | |
DBP | 1.643±13.209 | 1.041 | 0.3020 | |
SPO2 | -0.514± 2.848 | -1.511 | 0.1350 | |
C | RR | 0.771±1.811 | 3.564 | 0.0010* |
FIG. 2: OVERALL INCIDENCE OF SHIVERING
TABLE 4: OVERALL INCIDENCE OF SHIVERING
Shivering | GROUP | Total (%) | Chi squared χ 2 | |||
C(%) | D(%) | T(%) | ||||
Non | 48(68.6) | 65(92.9) | 60(85.7) | 173(82.4) | χ2= | |
Shivering | 22(31.4) | 15.02 | ||||
5(7.1) | 10(14.3) | 37(17.6) | P= | |||
Shivering | ||||||
0.001 | ||||||
70 | 70 | 70 | 210 | |||
Total | ||||||
(100.0) | (100.0) | (100.0) | (100.0) |
The use of Dexmedetomidine was associated with hypotension in 22 (31.4%) patients, bradycardia in 25 (55.7%) patients, and sedation in 19 (7.1%) patients who were less compared to those seen in Tramadol group Fig. 3. There was no significant difference between the groups for shivering Grade Table 5.
FIG. 3: SIDE EFFECTS
TABLE 5: SHIVERING GRADE AT DIFFERENT INTERVALS (NUMBER OF PATIENTS EXPRESSED AS PER GRADE 0/1/2/3)
Intervals | Group C | Group D | Group T |
0 | 37/33/0/0 | 68/2/0/0 | 57/13/0/0 |
5 | 8/56/6/0 | 68/2/0/0 | 52/18/0/0 |
10 | 6/50/14/0 | 67/3/0/0 | 49/21/0/0 |
15 | 3/25/42/0 | 60/1/0/0 | 42/27/1/0 |
25 | 2/17/46/5 | 67/3/0/0 | 42/27/1/0 |
40 | 2/20/37/11 | 66/4/0/0 | 44/26/0/0 |
60 | 2/31/22/15 | 70/0/0/0 | 62/8/0/0 |
90 | 5/34/31/0 | 70/0/0/0 | 54/16/0/0 |
120 | 14/39/17/0 | 69/1/0/0 | 55/14/1/0 |
150 | 20/38/12/0 | 70/0/0/0 | 70/0/0/0 |
Compared to group T, the sedation score was higher in group D without respiratory depression, and early cessation of shivering was also observed in group D. This shows Dexmedetomidine to be better than tramadol for prevention of shivering in post spinalanaesthesia.
DISCUSSION: The current study showed that both Dexmedetomidine 0.5 µg/kg and Tramadol 0.5mg/kg decreased the incidence and intensity of shivering in patients exposed to elective operations under spinal anaesthesia when compared to the control group, but these drugs could not prevent the significant decrease in the core temperature after the subarachnoid block. This anti-shivering effect was not associated with increased side effects 8.
In addition, Dexmedetomidine was superior in increasing the level of sedation which is sufficient to prevent anxiety with fewer side effects. Since the elimination half-life of Dexmedetomidine was short (2 hours) and had a single dose application, long-term postoperative follow-up was not found to be necessary.
In a study conducted by Gertler et al. 9 in Intravenous regional anaesthesia cases where Dexmedetomidine 1μg/kg was used in premedication to prevent post-anesthetic shivering at a loading dose of 1μg/kg, respiratory depression was not reported. The results of the study are comparable to the results of the study done by Bozgeyik et al 10 where the authors have concluded that pre-emptive Tramadoland Dexmedetomidine are effective in preventing shivering after spinal anaesthesia. Dexmedetomidine also provided sedation, sufficient to prevent anxiety without any adverse effect 11, 12. Usta et al. reported effective prevention of shivering and adequate sedation with the use of Dexmedetomidine infusion in patients during spinal anaesthesia 13. Usta et al. 13 found that Dexmedetomidine decreases the incidence of shivering from 57% in the control group to 10%; the side effects were found to be higher in the case of Tramadol as compared to Dexmedetomidine.
In this study, the incidence of nausea was highly significant in the Tramadol group compared to the Dexmedetomidine group (P < 0.001). Similarly, the incidence of vomiting was significantly higher in the Tramadol group compared to the Dexmedetomidine group (P = 0.041). These results are similar to those found in a study by Li S et al.14
Postoperative nausea and vomiting (PONV) is a very unpleasant experience for the patient 15. Postoperative vomiting/retching can lead to severe but rare medical complicatins, such as aspiration of gastric contents, suture dehiscence, oesophageal rupture, subcutaneous emphysema, or pneumothorax 16. PONV may delay discharge from PACU and can be the leading cause of unexpected hospital admission after ambulatory anaesthesia 17.
The limitation of our study was that the core body temperature could not be measured. For measurement of core body temperature, the probe needs to be put in the mid-esophagus, near the tympanic membrane, or in the urinary bladder. While a probe in the mid-esophagus or near the tympanic membrane is uncomfortable and unacceptable for patients who have been given SA, a probe in the urinary bladder would be an undue source of infection for the patient. Axillary temperature was recorded at regular intervals perioperatively until the end of the study.
CONCLUSION: Dexmedetomidine can be a good anti-shivering agent as it is effective and comparably better than Tramadol in preventing post-spinal anaesthesia shivering. It also provides sedation without respiratory depression and favours surgical conditions. However, it also has some side effects, like hypotension and bradycardia. Further research is required to search for an ideal drug for the prevention of post anaesthesia shivering.
ACKNOWLEDGMENT: The authors thank all the contributors for supporting this study. The authors also thank all the participating patients.
CONFLICT OF INTEREST: NIL
REFERENCES:
- Luggya, TS, Kabuye, RN, Mijumbi C, Tindimwebwa JB and Kintu A: Prevalence, associated factors and treatment of post spinal shivering in a Sub-Saharan tertiary hospital: a prospective observational study. BMC Anesthesiol 2016; 16(100). https://doi.org/10.1186/s12871-016-0268-0
- Lopez MB: Postanaesthetic shivering - from pathophysiology to prevention. Rom J Anaesth Intensive Care 2018; 25(1): 73-81. doi: 10.21454/rjaic.7518.251.xum. PMID: 29756066; PMCID: PMC5931188.
- Lamontagne C, Lesage S, Villeneuve E, Lidzborski E, Derstenfeld A and Crochetiere C: Intravenous dexmedetomidine for the treatment of shivering during Cesarean delivery under neuraxial anesthesia: a randomized-controlled trial. Can J Anaesth July 2019; 66(7): 762-771. doi:10.1007/s12630-019-01354-3
- Botros JM, Mahmoud AMS, Ragab SG, Ahmed MAA, Roushdy HMS and Yassin HM: Comparative study between Dexmedetomidine and Ondansteron for prevention of post spinal shivering. A randomized controlled trial. BMC Anesthesiol 2018; 18(1): 179. doi: 10.1186/s12871-018-0640-3. PMID: 30501612; PMCID: PMC6267838.
- Nakagawa T, Hashimoto M, Hashimoto Y, Shirozu K and Hoka S: The effects of tramadol on postoperative shivering after sevoflurane and remifentanil anesthesia. BMC Anesthesiol 2017; 17(1): 1. doi: 10.1186/s12871-016-0295-x. PMID: 28125971; PMCID: PMC5267365.
- Murmu R, Das A and Roychoudhury S: Comparison of prophylactic dexmedetomidine and ketamine for the control of shivering under spinal anaesthesia. Int J Adv Med 2021; 8: 685-90.
- Craig, D and Carli F: Bromage motor blockade score – a score that has lasted more than a lifetime. Can J Anesth/J Can Anesth 2018; 65: 837–838.
- Cao C, Meng LV, Wei C, Yan J, Wang Y and Gu C: Comparison of dexmedetomidine and meperidine for the prevention of shivering following coronary artery bypass graft: study protocol of a randomised controlled trial. BMJ Open 2022; 12: 053865.
- Gertler R, Brown HC, Mitchell DH and Silvius EN: Dexmedetomidine: a novel sedative-analgesic agent. Proc (BaylUniv Med Cent) 2001; 14(1): 13-21. doi: 10.1080/08998280.2001.11927725. PMID: 16369581; PMCID: PMC1291306.
- Bozgeyik S, Mizrak A, Kılıç E, Yendi F and Ugur BK: The effects of preemptive tramadol and dexmedetomidine on shivering during arthroscopy. Saudi J Anaesth 2014; 8(2): 238-43. doi: 10.4103/1658-354X.130729. PMID: 24843340; PMCID: PMC4024684.
- Liu S, Zhao R, Yang RL, Zhao HL, Ji C and Duan ML: Are dexmedetomidine and olanzapine suitable to control delirium in critically ill elderly patients. A retrospective cohort study. Biomedicine & Pharmacotherapy 2021; 139: 111617. https://doi.org/10.1016/j.biopha.2021.111617
- Shehabi Y, Howe BD, Bellomo R, Arabi YM, Bailey M and Bass FE:Early Sedation with Dexmedetomidine in Critically Ill Patients. N Engl J Med 2019; 380: 2506-17. DOI: 10.1056/NEJMoa1904710
- Usta B, Gozdemir M, Demircioglu RI, Muslu B, Sert H and Yaldiz A: Dexmedetomidine for the prevention of shivering during spinal anesthesia. Clinics 2011; 66(7): 1187-91. doi: 10.1590/s1807-59322011000700011. PMID: 21876972; PMCID: PMC3148462.
- Li S, Liu T, Xia J, Jia J and Li W: Effect of dexmedetomidine on prevention of postoperative nausea and vomiting in pediatric strabismus surgery: a randomized controlled study. BMC Ophthalmol 2020; 20: 86. https://doi.org/10.1186/s12886-020-01359-3
- Shaikh SI, Nagarekha D, Hegade G, Marutheesh M: Postoperative nausea and vomiting: A simple yet complex problem. Anesth Essays Res 2016; 10(3): 388-396.
- Turner AR and Turner SD: Boerhaave Syndrome. [Updated 2021 Dec 15]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan.https://www.ncbi.nlm.nih.gov/books/NBK430808/
- Xie C, Zhang C, Sun H and Lu Y: Effects of Dexmedetomidine on Postoperative Nausea and Vomiting in Adult Patients Undergoing Ambulatory Thyroidectomy: A Randomized Clinical Trial. Front Med 2021; 8: 781689. https://doi.org/10.3389/fmed.2021.781689.
How to cite this article:
Mahor J, Godwin R, Setiya M, Garg T and Mehani R: Comparison of efficacy of dexmedetomidine and tramadol for prophylactic use in post spinal anaesthesia shivering a prospective randomized controlled study. Int J Pharm Sci & Res 2023; 14(3): 1452-58. doi: 10.13040/IJPSR.0975-8232.14(3).1452-58.
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IJPSR
J. Mahor, R. Godwin, M. Setiya, T. Garg * and R. Mehani
Department of Pharmacology, People’s College of Medical Sciences& RC, Bhopal, Madhya Pradesh, India.
tanu43210@gmail.com
22 July 2022
26 August 2022
19 September 2022
10.13040/IJPSR.0975-8232.14(3).1452-58
01 March 2023