EFFICACY OF INTRAVENOUS ONDANSETRON FOR PREVENTION OF SHIVERING IN SPINAL ANAESTHESIA ADMINISTERED IN ELDERLY PATIENTS.
Objective: To determine the efficacy of intravenous Ondansetron for prevention of shivering in elderly patients undergoing spinal anesthesia.
Study Design: Double blinded randomized controlled trial.
Place and Duration of Study: It was conducted in Anesthesiology department, CMH Rawalpindi; 1st July, 2014 to 31st December, 2014.
Material and Methods: Eighty Patients were selected for this study, and randomly divided in two groups consisting of 40 patients each. Patients were preloaded with pre-warmed Ringer's lactate at dose of 10 ml/kg. Group A was given IV ondansetron 08 mg five min prior to administration of spinal anesthesia, whereas Group B was given Normal Saline. Core and axillary temperatures were monitored preoperatively, at 30, 60 and 90 min for both groups. Both groups were observed for shivering.
Results: There was no statistically significant difference between average age, weight, height, BMI, core and axillary temperatures preoperatively, at 30 min, 60 min and 90 min. Shivering was observed in 07 patients in Group A, and 16 patients in Group B. Difference between groups was statistically significant. (p = 0.026)
Conclusion: Intravenous administration of 08 mg of Intravenous Ondansetron prior to subarachnoid block, is effective in decreasing frequency of shivering.
Keywords: Intravenous Ondansetron, Shivering, Spinal Anesthesia.
Shivering is the one of the most commonly observed complications in anesthesia practice. It has a very high incidence (60 %) in general anaesthesia1, whereas the incidence in regional anaesthesia ranges between 40-60 %2. It can have different adverse effects associated with it, like it can increase metabolic rate, which increases oxygen consumption, leading to hypoxia, increasing the risk of myocardial insult3. This risk is more in elderly patients. In addition, shivering can also result in increased incidence of bleeding, floating clots, infection, increased carbondioxide production and even lactic acidosis. Also, it can interfere with monitoring of the patient (ECG, Pulse oximetry), and is unpleasant for the patient4.
Prevention has always been considered better than cure, and hence different intravenous drugs have been tested to find out a better prophylaxis against Shivering. Researchers have tested drugs like Meperidine, Dexmedetomidine, Tramadol, clonidine, Ketamine etc. However, they have different problems associated with them. For example, Meperidine is associated with nausea, vomiting, sedation, respiratory depression, bradycardia and hemodynamic changes etc5. Sedative effect of low dose ketamine2 can prove detrimental in elderly population. Tramadol is associated with Nausea and vomiting6.
Ondansetron, a 5-HT3 antagonist, is commonly used for prevention and treatment of intraoperative and Postoperative Nausea and vomiting7. It has also been demonstrated to reduce the incidence of Post Dural puncture Headache in patients undergoing LSCS in spinal anaesthesia8.
Incidence of Hypertension, Ischemic Heart disease and other comorbidities is higher in elderly patients. And shivering can expose them to further risk. Rationale of Our study is to find out the efficacy of ondansetron for reduction of shivering in elderly population.
Table-1: Comparison of age, height, weight and BMI between two Groups.
###Group A###Group B###p-value
Age (years)###63.78 +- 8.45###62.83 +- 8.95###0.627
Height (cm)###167.95 +- 4.48###168.82 +- 5.001###0.412
Weight (kg)###72.85 +- 5.74###74.18 +- 6.90###0.353
BMI###25.20 +- 1.81###25.45 +- 1.88###0.547
Table-2: Comparison of core and axillary temperatures between two groups
###Group A###Group B###p-value
###Preoperative###36.81 +- 0.18###36.85 +- 0.15###0.285
Core###30 min###36.52 +- 0.13###36.47 +- 0.13###0.107
temperature###60 min###36.16 +- 0.14###36.11 +- 0.15###0.162
###90 min###36.11 +- 0.14###36.09 +- 0.13###0.800
###Preoperative###36.20 +- 0.23###36.24 +- 0.21###0.426
Axillary###30 min###36.04 +- 0.20###36.07 +- 0.18###0.554
temperature###60 min###35.98 +- 0.17###35.99 +- 0.14###0.717
###90 min###35.96 +- 0.17###35.91 +- 0.17###0.363
Table-3: Comparison of frequency of shivering between two groups.
MATERIAL AND METHODS
This study was carried out in Main operation Theatre, CMH Rawalpindi from 1st July, 2014 to 31st December, 2014 after taking approval from Hospital Ethical Review Committee. Those patients were included in the study who were considered otherwise fit for spinal anaesthesia, male, age over 50 years, BMI between 20-30. Exclusion criteria included patients with any complains or history of running fever, Raynaud's syndrome, Thyroid disease, dysautonomia, Parkinson's disease or requirement of blood transfusion and surgery more than 90 minutes.
Patients were selected using convenience sampling. After taking consent from the patients, they were divided into Two Groups (A and B) of 40 each using computer generated table of Random numbers. Operation Theatre temperature was kept at 21-22 degC, and When patients arrived at operation theatre, they were cannulated with 18 G cannula, and were infused with pre-warmed (37degC) Ringer's lactated at dose of 10 ml/kg over 15 minutes. Group A was given 08 mg IV ondansetron 05 minutes prior to administration of spinal anesthesia. Patients of Group B were given normal saline for sake of blinding. Vital signs were recorded. Axillary temperature and core temperature were monitored 03 min prior to spinal anaesthesia. 02 ml of 0.75% Bupivacaine was administered via 25 G spinal needle at L3-4 level for spinal anaesthesia.
Pin prick and inability to lift leg, were used to ensure sensory and motor blockage. Heart rate, ECG and SpO2 were continuously monitored, whereas blood pressure was monitored every 03 minutes for first 15 min, followed by every 05 min for rest of procedure. Hypotension was treated by ringer's lactate infusion, and IV injection Phenylephrine. Axillary and core temperatures were monitored at 30 min, 60 min and 90 minutes. Shivering was observed in this period of time, and was defined as fasciculation in pectoralis major for more than 10 seconds. These patients were labeled as "Shivering Present". IV Pethidine at dose of 0.3 mg/kg was used for treatment of shivering.
SPSS version 20 was used for analysis of data. Age, weight, height, BMI and core and axillary temperatures were compared using independent samples T-test. Frequency of shivering was compared using chi square test. P value < 0.05 was taken as significant.
A total of 80 patients were selected, divided in two groups of 40 each. There was no statistically significant difference between average age, weight, height and BMI between the two groups (table-1). Similarly, there was no statistically significant difference between Core and axillary temperatures between the two groups, preoperatively, at 30 min, 60 min and 90 min (table-2). Shivering was present in 07 patients (17.5%) in Group A, and in 16 patients (40%) in Group B. This difference between the two groups is statistically significant (p = 0.026) (table-3).
Shivering is a very common finding in patients undergoing Spinal Anaesthesia . It has different effects on body, especially putting stress on the myocardium3 by increasing oxygen demand, and thus leading to hypoxia. The exact mechanism is not fully known in spinal anaesthesia, however, it is suggested that vasodilation in legs leads to more heat loss, and so core temperature is distributed to legs. Shivering and vasoconstriction cannot take place below the level of blockade, and is restricted to upper body parts9.
Different drugs have been tested for use as prophylactic measure. Pethidine has been tested for its efficacy in prevention of shivering4, however, its side effects like sedation, respiratory depression, bradycardia and hemodynamic changes5 can prove troublesome in elderly patients. Dexmedetomidine has been tested by some researchers9,10, and was found effective. However, it is not commonly available in our market. Tramadol6 and ketamine have been used too, and ketamine was found more effective in prevention of shivering11. However, Sedative effects of ketamine2 can prove troublesome in elderly population.
Ondansetron is a 5-HT3 Antagonist, and is primarily used for Prevention and treatment of Nausea and vomiting7. It also decreases the incidence of Post dural puncture headache8. It has also been demonstrated that it decreases the incidence of hypotension in spinal anesthesia12. These effects make it a very useful adjunct in patients undergoing spinal anesthesia.
We decided to look into efficacy of ondansetron for prevention of shivering in elderly patients. Its mechanism is not fully clear, however, it is suggested that serotonergic pathways play some part in regulation of shivering13.
There are other studies on this subject too, however, these mainly differ in fact that they were not performed in elderly population. This is one of the basic differences since we thought that shivering predisposes elderly patients to stress on myocardium.
Kelsaka et al14 took 75 patients, and distributed them in three groups of 25 patients each. He compared ondansetron, meperidine and placebo. They found that Meperidine and ondansetron had similar efficacy in prevention.
Safavi et al5 also compared intrathecal Meperidine with intravenous ondansetron for prophylaxis against shivering in orthopedic cases. They also concluded that both were comparable in reducing frequency of shivering. However, they differ from our study in that; the average age of their patients was <40.
Marashi et al15 compared two different doses (06 mg and 12 mg) of Ondansetron for the sake of prevention. And they concluded that there was no difference between efficacies of two doses. This is one of the differences from our study as we had used 08 mg for the sake of prophylaxis. Also, they did not exclude younger patients.
Apart from spinal anesthesia, ondansetron also reduced frequency of shivering in general anesthesia. Powel and Buggy13 demonstrated this in their study, in which they gave 08 mg of ondansetron just before induction of anesthesia, and it decreased frequency of shivering. Also, Ali Reza Mahoori et al16 demonstrated that 08 mg of intravenous ondansetron can effectively treat shivering associated with general anesthesia. They had compared it with 0.4 mg/kg of meperidine and 04 mg ondansetron. They concluded that 08 mg ondansetron and 0.4mg/kg of meperidine had same effect.
In our study, we decided to include patients above 50 years of age, and use ondansetron at dose of 08 mg. It was concluded that it decreased the frequency of shivering significantly. However, we did not compare ondansetron with other drugs which are used for prophylaxis against shivering like low dose ketamine, meperidine, tramadol.
We suggest that more attention should be paid to research in elderly population. And comparison should be made between these drugs.
CONFLICT OF INTEREST
The authors of this study reported no conflict of interest.
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|Publication:||Pakistan Armed Forces Medical Journal|
|Article Type:||Clinical report|
|Date:||Feb 29, 2016|
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