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Journal Homepage: - : Introduction
12(10), 1355-1360
RESEARCH ARTICLE
A COMPARATIVE STUDY OF DEXMEDETOMIDINE AND TRAMADOL IN THEPREVENTION OF
INTRAOPERATIVE SHIVERING IN PATIENTS UNDERGOING SURGERY UNDER SPINAL
ANAESTHESIA
Dr. Jyothi Sheelavantar, Dr. Mohammad Yahya, Dr. Pratima B. Patil and Dr. Priyanka Patil
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Manuscript Info Abstract
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Manuscript History Background: Shivering is a common and distressing experience to
Received: 27 August 2024 patients which occurs either during or immediately after the surgery. It
Final Accepted: 29 September 2024 is defined as an involuntary, repetitive activity of skeletal muscles.
Published: October 2024 Spinal anaesthesia impairs the thermoregulatory system by inhibiting
vasoconstriction, and results in redistribution of core heat to the
Key words:-
Dexmedetomidine, Tramadol, Pethidine, periphery from the trunk. Both these effects predispose patients to
Shivering, Spinal Anesthesia hypothermia and shivering. commonly used drugs for treatment of
hypothermia are pethidine, tramadol, dexmedetomidine, clonidine.
Objective: To study the efficacy and side effects of dexmedetomidine
and tramadol in the prevention of intraoperative shivering.
Materials and method: This study is on patients undergoing lower
abdominal surgeries and lower limb general surgeries under spinal
anaesthesia was done in basaweshwara teaching and general hospital,
MR medical college gulbarga. It was a prospective study including 60
consented patients of age group 18 – 65 years belonging to American
society of anesthesiologist’s class I or II and posted for lower abdominal
surgeries and lower limb general surgeries under spinal anesthesia were
randomly allocated to Dexmedetomidine and Tramadol groups.
Results: This study included 60 patients, 30 in each group. There was
statistically significant difference in group D and Group T at 15 min (
p<0.045) and at 30 min (p<0.003). The rescue drug was used more in
tramadol group which included 12 patient's and only 1 in
dexmedetomidine group. p value for this is 0.001 which is highly
significant.
Conclusion: Dexmedetomidine is more effective in the prevention of
shivering when compared to tramadol. Dexmedetomidine has an added
advantage of adequate reliable sedation. Hence, we conclude that
Dexmedetomidine is most effective in the prevention of shivering when
compared to tramadol.
In patients undergoing neuraxial anaesthesia, shivering is a normal thermoregulatory mechanism as evidenced by the
presence of vasoconstriction before shivering . Spinal anaesthesia impairs the thermoregulatory system by inhibiting
vasoconstriction, which plays an important role in temperature regulation. Spinal anaesthesia results in redistribution
of core heat to the periphery from the trunk [below the level of block] 2. Both these effects predispose patients
undergoing spinal anesthesia to hypothermia and shivering.
Many studies on tramadol showed its efficacy in the treatment of shivering. Tramadol produces adverse effects like
nausea, vomiting, dizziness etc., which can create further discomfort to the patient 3. Dexmedetomidine is a
selective α2 adrenergic agonist and has 1600 times greater selectivity for the α2 adrenoceptor compared with the α1
receptor. It produces sedation, anxiolysis, hypnosis, analgesia, sympatholysis and has anti shivering properties .
Objective:-
1. To study the efficacy of dexmedetomidine, tramadol in the prevention of intra operative
shivering.
2. To study the side effects caused by the study drugs like nausea , vomiting, sedation.
Inclusion Criteria:
1. ASA grade I or II
2. Age 18 to 65 years
3. Undergoing Spinal anaesthesia
4. Lower abdominal surgeries and lower limb general surgeries.
Exclusion Criteria
1. Known hypersensitivity or allergy to study drugs.
2. Cardio-pulmonary, renal , hepatic or thyroid impairment.
3. Known history of substance or alcohol abuse
4. An initial core temperature >37.5˚C or <35.5˚C
5. Blood transfusion during surgery
6. Convulsions or psychiatric disorder
7. Pregnancy and lactation
Procedure:-
Patients were shifted to the operation theatre and all monitors were connected The operation room temperature was
maintained at 25 0C.
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Spinal anaesthesia was given .Oxygen via face mask at 5L/min was administered to all the subjects. Inj.Ondansetron
4mg IV was given to all the patients. Surgery will commence when the level of sensory block reaches T8. Patients
were monitored for a period of 120 minutes or the end of the surgery whichever was longer.
Patient’s baseline Heart rate, Blood pressure, Temperature and SpO2 was monitored and monitoring of all these
parameters were done for every 5 minutes till 15 minutes and then every 15 minutes till 120 minutes.
Patients who developed shivering during the study period were given Inj.tramadol 0.25mg/kg IV bolus as rescue
drug. Any other adverse effects during the study period was noted.
Statistical Analysis:
Collected data was analysed by using IBM SPSS 20.0 version software. T test and ANOVA test was used as test of
significance. P value <0.05 IS CONSIDERED STATISTICALLY SIGNIFICANT.
Results:-
Most of the patients in the study belonged to age group 41-50 years. Mean age of patients in tramadol group was
39.97 years, in dexmedetomidine group it was 38.70 years
Age group No of pts in Tramadol group No of pts in Dexmedetomidine group
<30yrs 8 5
30-40yrs 6 10
40-50yrs 11 8
50-60yrs 5 7
Total 30 30
Number of male and female patients were 21 and 9 in tramadol group respectively.and in dexmed group 25 and 5
respectively.
The number of patients who belong to ASA I were 23 and ASA I I were 7 in tramadol group and in
dexmedetomidine group ASA I 24 and ASA I I 4 patients.
None of the patient in any of the groups had shivering at 0,5 and 10 minutes. In tramadol group, at 15 minutes, 2
patients had shivering of grade 3, 3patients had shivering of grade 2 and 1 patient had shivering of grade 1. In
dexmed group, there was no shivering.
At 30 minutes, 8 patients in tramadol group had grade 3 shivering and 3 patients had grade 1 shivering, and in
dexmedetomidine group, 1 patient had grade 1 shivering.
At 45 minutes, 2 patients in tramadol group had grade 3 shivering and 1 had grade 1 shivering, 1 patient in
dexmedetomidine group had grade 3 shivering.
At 60 minutes, 1 patient in tramadol group had grade 1 shivering, no patients in dexmed group had shivering.
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At 75 minutes, 1 patient in tramadol group had grade 1 shivering, and no patient in dexmedetomidine group had
shivering.
P value at 15 minutes is 0.045 which is <0.05 and is statistically significant. P value at 30 minutes is 0.003 which is
<0.01 and so, highly significant. P value at other duration are not significant.
At 5 minutes, no patients in tramadol had sedation but in dexmedetomidine group, 20 patients had grade 2 sedation
and 5 had grade 3 sedation scores. At 10 minutes, no patients in tramadol had sedation but in dexmedetomidine
group, 10 patients had grade 2 sedation and 17 patient had grade 3 sedation. At 15 minutes, 5 patients in tramadol
group had grade 2 sedation. In dexmedetomidine group, 8 and 20 patients had grade 2 and 3 sedation respectively.
At 30 minutes, in tramadol group, 12 and 1 patient had grade 2 and 3 sedation respectively, In dexmedetomidine
group, 7 and 22 patients had grade 2 and 3 sedation respectively.
At 45 minutes, in tramadol group, 14 patient had grade 2 sedation.in dexmedetomidine group, 7 and 22 patients had
grade 2 and 3 sedation respectively. At 60 minutes, 15 patients in tramadol group had grade 2 sedation. in
dexmedetomidine group, 10 patient had grade 2 and 18 grade 3 sedation scores.
At 75 minutes, 11 patients in tramadol and in dexmedetomidine group, 19 had grade 2 and 5 had grade 3 sedation.
At 90 minutes, in tramadol group, 7 patients had sedation score of 2and in dexmedetomidine group, 21 patients had
score 2 and 1 had score of 3. At 105 minutes, all patients in tramadol group had sedation score of 1 and 13 patients
in dexmedetomidine group had a score of 2. At 120 minutes, no patient had sedation score greater than one. The P
value was highly significant from 15 minutes till 105 minutes.
The mean heart rate was similar in both groups with mean heart rate around 80 bpm. The P value is > 0.05 and
hence, not significant.
The systolic blood pressure(SBP) and DBP was comparable between in both groups with insignificant P values.
The axillary temperature measured during the study in all the three groups showed comparable values with
insignificant P values.
In this study we used Inj Tramadol 0.25mg/kg IV bolus as Rescue drug. In our study 12 patients (40%) needed
additional rescue anti shivering drug in tramadol group and1 patient in dexmedetomidine group required rescue
drug. The P value for this is 0.001 which is highly significant.
In this study, 2 patients from dexmedetomidine group had a fall in systolic blood pressure to less than 90 mm Hg
during the study period. Patients in other group did not have any hypotension. The P value for this is 0.715 which is
not significant.
In this study, no patient from tramadol group had bradycardia, but, three patients from dexmedetomidine group had
bradycardia. The P value is 0.067 which is not statistically significant.
Discussion:-
Lower abdominal and lower limb surgeries are usually done under spinal anaesthesia. One of the least addressed and
a very distressing complaint in many of the patients is shivering during the surgery and in the immediate
postoperative period. it is crucial to sufficiently sedate the patient following spinal anesthesia administration. The
majority of sedatives cause hypotension, bradycardia, and inconsistent sedation.
Many studies were conducted in patients who underwent general anaesthesia. The number of studies conducted after
spinal anaesthesia are relatively less. Various studies were conducted after the onset of shivering for its treatment.
We planned a study to find out the efficiency of these drugs in the prevention of shivering. Our study was planned in
a prospective and randomized manner to study the efficacy of these three drugs in the prevention of shivering. The
study was double blinded. In our study the sample size was calculated as 60 .
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Of the two medications used in the trial, dexmedetomidine was found to be more effective than the other two in
preventing shivering, as evidenced by the fact that only one patient out of 30 who received dexmedetomidine
experienced shivering. This result is in accordance with the report by Lim fern et al 4 study which also had a similar
outcome. Tramadol group patients had the highest incidence of shivering with 12 patients in that group had
shivering grade >2. When compared with Mittal et al 5 study, which was a 2 drug comparison between
dexmedetomidine and tramadol, showed that both drugs were equally effective but dexmedetomidine had a faster
onset of action. Again, it was an intraoperative study where drugs were given after the onset of shivering.
Drugs used in the study for prevention of shivering can cause sedation to varying degrees. So no other sedatives or
hypnotics or anxiolytics were given during the study. Undoubtedly, dexmedetomidine stood far superior to tramadol.
The onset of sedation was almost 5 minutes and had a sedation score of 3 (Drowsy, arousable to physical stimuli) in
most of the patients. Sedation after the bolus dose lasted for over 90 minutes and patients were comfortable during
the surgery. In tramadol group, only 40% of the patients were sedated and the sedation scale was also 2. The onset
of sedation was also slower and was around 15 minutes. Mittal et al 5 concluded the study as sedation due to
dexmedetomidine provides additional comfort to the patient. The sedation caused by dexmedetomidine causes the
patient to be in a tranquil state but follows oral commands as seen in Elvan et al 6. The sedation score was higher in
dexmedetomidine group starting from 5 minutes as observed in Bozgeyik et al 7 as this has the similar result in our
study too.
Side effects
Side effects Tramadol Dexmed group
Bradycardia 0 3
Hypotension 0 2
Respiratory depression 0 0
Hypotension and bradycardia are known hemodynamic effects of dexmedetomidine but only few patients have those
side effects which is acceptable as concluded by Lim fern et al 8. Hypotension and bradycardia were seen in
dexmedetomidine group but is of lesser incidence as concluded by Usta B et al9 which was the similar observation
in our study also.
There are limitations in our study. Different doses of dexmedetomidine and difference between use as infusions and
bolus doses are to be evaluated for preventing shivering as to which is ideal with minimum haemodynamic adverse
effects, which needs further studies. The dose of tramadol used for the study at 0.5mg/kg proved to be insufficient
and higher doses of tramadol at 1mg/kg may be needed to prevent shivering and further studies on different dosing
of the drug in similar conditions will help in sorting out the same.
Conclusion:-
Dexmedetomidine is more effective in the prevention of shivering when compared to tramadol.
Hence we conclude that Dexmedetomidine at 0.5µg/kg is most effective in the prevention of shivering when
compared to tramadol.
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4. Lim Ferna and Karis Misiranb. Comparison of dexmedetomidine, pethidine and tramadol in the treatment
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