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View of Intravenous Magnesium Sulfate in Comparison to Tramadol in Prevention of Post Spinal Shivering in Geriatric Patients Undergoing Transurethral Resection of Prostate

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Intravenous Magnesium Sulfate in Comparison to Tramadol in Prevention of Post Spinal Shivering in GeriatricPatients Undergoing Transurethral

Resection of Prostate

JamaahHusaynQareen(1),Ashraf Said Sayed(2), Hala Ibrahim Zanfaly(2), Fatma Mahmoud Ahmed(2)

(1)Department of Anesthesia andSurgical Intensive Care, Faculty of Medicine,Sirte University,Libya

(2)Department of Anesthesia andSurgical Intensive Care, Faculty of Medicine,Zagazig University, Egypt.

Corresponding Author: JamaahHusaynQareen E-mail : [email protected] Abstract

Background: Postanesthetic shivering is a frequent complication of anesthesia, perhaps even aggravating pain especially during (TURP) surgery. The aim of the present study was to compare the efficacy of 15mg/kg of I.V MgSo4 and 0.5mg/kg of tramadol to placebo normal saline on incidence and severity of postspinal shivering in geriatric patients undergoing (TURP) surgery, when used as prophylaxis. Patients and methods:This is a comparative prospectivestudy was included 39 geriatric male patients who scheduled for performing an elective (TURP) surgery under the SAB at Zagazig University Hospitals. Patients were divided equally into 3 groups: Group C: were received isotonic saline after spinal anesthesia, Group Mg: were received I.V MgSO4 in isotonic saline.Group T: were received I.V tramadol inisotonic saline after spinal anesthesia. All patients were enrolled for examination before and after surgery.Results:There was no significant difference among the studied groups as regard HR, MAP and Spo2 between the three studied groups.Regarding changes in temperature between the studied groups, C group showed a significant lower Temperature time followed by Mg group then T group at different times. There was a significant higher rate of Shivering in C group then Mg group and the lowest T group, and onset of shivering was significantly faster in control then Mg group and longer significantly in Group T. Conclusion:Prophylactic administration of I.V tramadol in a dose of 0.5mg/kg immediately after SAB could be significantly reduces the incidence and severity of postspinal shivering more than I.V MgSo4 in adose of 15mg/kg in geriatric patients undergoing (TURP) surgery.

Keywords: Tramadol , MgSO4, Post Spinal Shivering, TURP INTRODUCTION:

Spinal anesthesia is known to significantly impair thermoregulation and predispose patients to hypothermia(1).General and epidural anesthesia alter the function of the autonomic nervous system, which plays a significant role in thermoregulation and interferes primarily with peripheral vasoconstriction below the level of the sympathetic blockade (2).

Shivering associated with spinal and epidural anesthesia is common, occurring in up to 56.7% of patients(3).

Shivering may interferes with monitoring of the electrocardiogram, blood pressure, and oxygen saturation. Furthermore, shivering increases oxygen consumption, lactic acidosis, carbon dioxide production, and metabolic rate by up to 400%. Thus, it may causes a problems in patients with low cardiac and pulmonary reserves(4).Shivering is an important problem for urologists, especially during transurethral resection of the prostate (TURP) surgery. Shivering may interferes with the surgeon's ability to visualize a resectable prostate tissue. Injury to the

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urethra, bladder, and rectum may occur during the procedure. As a result, shivering not only prolongs the operation time, it may also causes severe complications (5).

Geriatric patients have a higher incidence of morbidity and mortality during surgery than young age, also geriatric patients who undergoing (TURP) surgery have a cardiac risk because of medical problems. Hypothermia can complicates (TURP) surgery. Geriatric patients are predisposing to the risk of hypothermia which induces shivering after spinal anesthesia(6).

Magnesium sulfate (MgSo4) has anti-shivering effects. But it may enhances the rate of cooling because of its vasodilatory properties. Furthermore, it has a potential neuroprotective effects, and experimental data suggest that the neuroprotective effect of hypothermia may be increased with the addition of MgSO4 (7,8).

Tramadol is a centrally acting weak μ-opioid receptor analgesic. Administration of tramadol is a universally available cost-effective drug with the minimal side-effects. It is a cyclohexanol derivative which has μ agonist activity as well as acts as an inhibitor of serotonin and norepinephrine uptake. It is metabolized in the liver, it is mainly consumed as an analgesic (9)

Intravenous tramadol has been used for treatment of shivering. The use of oral tramadol 50 mg is effective as a prophylactic agent to reduce the incidence, severity and duration of perioperative shivering in patients undergoing(TURP) surgery under subarachnoid blockade (SAB) (10). The analgesic potency of tramadol is found to be a ten times lesser than morphine but is preferred being safe than the later. Tramadol is considered safe, as it does not cause respiratory depression and addiction when compared to other opioid analgesics (11). So far, there is no study to compare the effect of intravenous (I.V) MgSO4with I.V tramadol on postspinal anesthesia shivering.

The aim of the present study compare between I.V MgSo4 and Tramadol on incidence and severity of shivering in geriatric patients undergoing (TURP) surgery. To assess sensory, motor block and the highest level of sensory block in geriatric patients undergoing (TURP) surgery.

PATIENTS and METHODS:

A comparative prospectivestudy was included 39 geriatric male patients who scheduled for performing an elective (TURP) surgery under the SAB at Zagazig University Hospitals.

The work has been carried out in accordance World Medical Association (Declaration of Helsinki) for studies involving humans before prospective collection of patient’s data and after informed consent was obtained from patients.

Inclusion criteria:

Male geriatric patients aged between 65 to 70 years old with BMI less than 35 kg/m2 who scheduled to undergo elective TURP surgery under SAB will be enrolled into the study.

Patients of American society of anesthesiologists (ASA) physical status II and III.

Exclusion criteria:

Patients who had any history suggestive of allergy to the study medications.Thyroid dysfunction.Severe diabetic or autonomic neuropathy.Infection of the urinary tract. History of administration of vasodilators or vasoconstrictors as those drugs could interfere with the body thermoregulation. Preoperative fever (temperature ≥ 38°C).Contraindications to spinal anesthesia.Parkinson's disease.Raynaud's syndrome.

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Operative design and management:

Patients were divided equally into 3 groups: Group C;(n = 13) were received I.V 100 mL of isotonic saline slowly after spinal anesthesia as control group, Group Mg: (n = 13) were received I.V Mg SO4 15mg/kg in 100 mL isotonic saline slowly after spinal anesthesia.Group T: (n=13) were received I.V tramadol 0.5 mg/kg in 100mL isotonic saline slowly after spinal anesthesia(Fig. 1).

All patients were enrolled for examination before and after surgery. All patients were covered with one layer of surgical drapes over the chest, thighs, and calves during the operation, and one cotton blanket over the entire body postoperatively. No other warming device was used. Core temperature below 36°C was considered as hypothermia. Maximum sensory level was recorded. Degree of motor and sensory blockade was assessed intraoperatively every 5 minutes and also in the recovery unit.

Figure (1): Flow diagram of patients enrollment in the study.

Mean arterial blood pressure,heart rate ,peripheral oxygen saturation, tympanic temperature, sedation score, onset and duration of all were measured and recorded at the baseline beforer SAB and then every 5 minutes to the 1st 30 minutes after SAB then at 45 minutes then at the end of opereation and also at recovery room.

Shivering intensity was graded graded using a scale similar to that validated by Crossley and Mahajan(12), where 0 = no shivering, 1 = piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in one muscle group only, 3 = muscular activity in more than one muscle group. 4 = whole body shivering.

Statistical analysis

Data collected throughout history, basic clinical examination, laboratory investigations and outcome measures coded, entered and analyzed using Microsoft Excel software. Data were then imported into Statistical Package for the Social Sciences (SPSS version 20.0) software for analysis. According to the type of data qualitative represent as number and percentage, quantitative continues group represent by mean ± SD, the following tests were used to test differences for significance; difference and association of qualitative variable by

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Chi square test (X2). Differences between quantitative independent multiple by ANOVA. P value was set at <0.05 for significant results &<0.001 for high significant result.

RESULTS:

The attained results showed HR at different times was comparable between the three groups (p>0.05) (Figure 1). As regard MAP at different times, there were no significant differences between the three groups (p>0.05) (table 1). SPO2 at different times were comparable in the three groups (p>0.05)(table 2).

As regard the basal tympanic temperature there was no significant difference among the three groups (p>0.05). However at different times (5,10,15, 20,25,30) minutes there was a highly significant decrease in tympanic temperature in control group (p<0.001), at (45),at the end of opereation and at the recovery room there was significant decrease in tympanic temperature in control group when compared with the other two groups (p<0.05).On the other hand there was no significant differences in tympanic temperature at different times when compared Mg group with T group (p>0.05) (figure 2).

As regard the onset of sensory and motor block, there was a significant delay in control when compared with the other two groups (p<0.01).Duration of sensory block was (8.54±0.96), (14.83±2.12), (17.33±1.3) min in control, magnesium, tramadol group respectively with significant decrease (p<0.05) in control group compared to the other two groups, there was no significant difference between magnesium and tramadol groups(Figure 3).

Duration of motor block was (6.83±1.0), (10.66±1.37), (14.58±1.56)min in control, magnesium, tramadol group respectively with significant decrease (p<0.05) in control group compared to the other two groups, there was no significant difference between magnesium and tramadol groups (p>0.05) (Figure 4).

Shivering occurred in 10 patients (76.9%) in control group, in 4 patients (30.8%) in magnesium group and in 1 patients (7.7%) in tramadol group with significantly increased occurrence (p<0.05) in control group compared to the other two groups. There was a significant rapid onset of shivering in control group when compared with the other two groups (p<0.01) (table 3).

Figure 1: HR distribution at different times among the three groups

6870 7274 7678 8082 8486

Control Group Group mg Group T

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Table 1: MAP distribution at different times amongthe three groups

Time Group C

(N=13)

Group mg (N=13)

Group T

(N=13) P

MAP ( mmHg) Basal 93.75±3.3 93.83±2.62 94.75±2.92 0.670 MAP ( mmHg) 5 84.54±2.1 83.99±2.21 83.98±3.54 0.661 MAP ( mmHg) 10 81.22±2.5 81.58±2.87 81.11±2.58 0.654 MAP ( mmHg) 15 80.96±6.8 80.44±3.98 80.99±4.89 0.602 MAP ( mmHg) 20 77.73±2.4 79.21±2.63 78.87±2.92 0.512 MAP ( mmHg) 25 70.01±3.7 70.89±4.21 70.75±2.22 0.621 MAP ( mmHg) 30 71.87±3.9 72.21±3.33 71.54±2.01 0.655 MAP ( mmHg) 45 78.75±3.5 79.01±2.87 78.82±4.32 0.659 MAP ( mmHg) At the end of

opereation 82.25±3.8 83.23±2.87 82.75±3.36 0.487 MAP ( mmHg)

At the recovery

room

86.00±2.3 86.66±2.36 85.75±3.33 0.641 Data are expressed as mean ±SD.

P > 0.05 was considered non significant.

N= number, MAP=mean arterial blood pressure.

Table 2: SPO2 distribution at different times among the three groups

Time Group C

(N=13)

Group mg (N=13)

Group T

(N=13) P

SPO2 (%) Basal 98.58±0.51 98.41±0.51 98.58±0.52 0.660

SPO2 (%) 5 98.28±0.26 98.87±0.41 98.58±0.39 0.612

SPO2 (%) 10 98.68±0.87 98.93±0.55 98.58±0.52 0.689

SPO2 (%) 15 98.88±0.88 98.95±0.79 98.69±0.88 0.689

SPO2 (%) 20 99.02±0.35 99.16±0.26 99.19±0.51 0.712

SPO2 (%) 25 98.52±0.61 99.11±0.39 98.91±0.41 0.536

SPO2 (%) 30 98.99±0.65 98.87±0.87 98.75±0.55 0.679

SPO2 (%) 45 98.78±0.78 98.74±0.71 98.36±0.65 0.662

SPO2 (%) At the end of

the opereation 98.36±0.56 98.44±0.36 98.41±0.25 0.663 SPO2 (%) At the

recovery room 98.88±0.88 98.98±0.74 98.94±0.74 0.599 Data are expressed as mean ±SD.

P>0.05 was considered non significant.

SPO2:oxygen saturation.

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Figure 2: TEMP distribution at different times among the three groups

Figure 3: Onset of sensory and motor block among the three groups

36.136.2 36.336.4 36.536.6 36.736.8 36.937 37.1

Control Group Group mg Group T

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Figure 4: Duration of sensory and motor block among the three groups

Table 3: Shivering incidence and onset of shivering among the studied groups Group

X2/F P

Group C Group Mg Group T

Shivering

No N 3 9 12

% 23.1% 69.2% 92.3%

Yes N 10 4 1 13.65 0.001**

% 76.9% 30.8% 7.7%

Onset of shivering in

minutes 31.15±8.63* 39.55±6.23 43.63±5.74 5.236 0.002*

Data was expressed as mean±SD, numbers and percentage P<0.01 was considered significant.

DISCUSSION:

The present study compared the efficacy of i.v MgSo4 and tramadol to placebo normal saline on the incidence and severity of postspinal shivering in geriatric patients undergoing (TURP) surgery and found that i.v MgSO4 and tramadol significantly reduce the incidence and grades of shivering when used as a prophylaxis.

The present study showed no significant difference among the studied groups as regard heart rate (HR), mean arterial pressure (MAP) and SPO2. These results are in agreement with a randomized double blind cross-sectional study of Javaherforoosh et al., (13) who concluded that there is no significant differences between tramadol (in dose of 1mg/kg) and control groups regarding to heart rate (HR), mean arterial blood pressure (MAP),oxygen saturation SPO2.

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Additionally, hypotension was not statistically significant in the study by Ibrahim et al.

(14) who stated that, the incidence was being 15%. Also, Elsonbaty et al., (15) who reported that hypotension was observed in two patients who received pethidine and one patient who received magnesium.

A several studies suggested that, higher dose of magnesium is associated with peripheral vasodilatation with consequent hypotension, bradycardia, and hypothermia (Jee et al., (16); Gozdemir, (17). Therefore, the dose of mg used in this study was 15 mg/kg.

The present study showed that a changes in temperature between the studied groups, Control group was significantly lowest regard temperature followed by magnesium group then tramadol group. This results are in agreement with Tewari et al., (10) who observed a significant fall in the tympanic membrane temperature in the control group as compared with tramadol group (P< 0.001).

However, Sachidananda et al., (18) who revealed that the mean temperature changes was comparable among tramadol, magnesium and control groups at all study points. As their study didn't find any correleations between the incidence of shivering and the changes of temperature.

In the current study tramadol group and magnesium group reduced the incidence, severity and duration of shivering. This results are in agreement with Gozdemir et al., (17) who stated that (MgSo4) 80 mg/kg i.v administered as bolus over 30 min followed by infusion of 2 g/h significantly reduced shivering in patients receiving spinal anesthesia for transurethral resection of prostate though it increased the risk of hypothermia. Shivering occurred in 6.7% of patients who received magnesium and 66.7% of patients who received saline.

All the above studies support the use of I.V tramadol and I.V MgSo4 either as equally effective or superior to various drugs studied. Tramadol is safe with lesser side-effects. Also it is easily available and so both of tramadol and MgSo4 can be used as a prophylactic in geriatric patients undergoing TURP surgery.

CONCLUSIONS:

Prophylactic administration of I.V tramadol in a dose of 0.5mg/kg immediately after SAB could be significantly reduces the incidence and severity of postspinal shivering more than I.V MgSo4 in adose of 15mg/kg in geriatric patients undergoing (TURP) surgery.

REFERENCES:

1- Collins S, Budds M, Raines C, & Hooper V. Risk Factors for Perioperative Hypothermia:

A Literature Review. Journal of PeriAnesthesia Nursing 2019; 34(2): 338-346.‏

2- Lenhardt R. Body temperature regulation and anesthesia. In Handbook of clinical neurology 2018;157: 635-644.‏

3- Ghasemi M, Behnaz F, & Hajian H. The effect of dexmedetomidine prescription on shivering during operation in the spinal anesthesia procedures of selective orthopedic surgery of the lower limb in addicted patients. Anesthesiology and pain medicine 2018;8(2): e63230.‏

4- Lopez MB. Postanaesthetic shivering–from pathophysiology to prevention. Romanian journal of anaesthesia and intensive care 2018;25(1): 73-81.

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5- Tekgül ZT, Horsanali BÖ, & Horsanali MO. Anesthesia for Urological Surgery. Current Topics in Anesthesiology 2017; 53-97.

6- Ebied, R. S., Ali, M. Z., Khafagy, H. F., Maher, M. A., & Samhan, Y. M.: Comparative study between continuous epidural anaesthesia and continuous Wiley Spinal® anaesthesia in elderly patients undergoing TURP. Egyptian Journal of Anaesthesia, 2016; 32(4), 527- 533.‏

7- Binette A, Blouin S, Ardilouze A, & Pasquier JC. Neuroprotective effects of antenatal magnesium sulfate under inflammatory conditions in a Sprague–Dawley pregnant rat model. The Journal of Maternal-Fetal & Neonatal Medicine 2017; 30(14): 1715-1720.‏

8- Mostafa MF, Hassan ZEAZ, & Hassan SM. Corrected and republished: shivering prevention during cesarean section by intrathecal injection of magnesium sulfate:

randomized double-blind controlled study 2019;6: 252–258.

9- Bravo L., J.A. Mico, E. Berrocoso, Discovery and development of tramadol for the treatment of pain, Expert Opin. Drug Discov. 12 (2017) 1281–1291.

10- Tewari, A., Dhawan, I., Mahendru, V., Katyal, S., Singh, A., & Garg, S.: Use of oral tramadol to prevent perianesthetic shivering in patients undergoing transurethral resection of prostate under subarachnoid blockade. Saudi journal of anaesthesia, 2014;

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11- Subedi, M., Bajaj, S., Kumar, M. S., & YC, M. An overview of tramadol and its usage in pain management and future perspective. Biomedicine & Pharmacotherapy, 2019;111, 443–451.

12- Crossley AW, Mahajan RP. The intensity of postoperative shivering is unrelated to axillary temperature. Anaesthesia, 1994; 49(3), 205-207.

13- Javaherforoosh F , Akhondzadeh R, Aein KB, Olapour A, Samimi M. Effects of tramadol on post spinal anesthesia shivering in electivecesarean section. Pak J Med Sci.

2009;25:12–7.

14- Ibrahim IT , Megalla SA, Khalifa OS, Deen HM. Prophylactic vs. Therapeutic magnesium sulfate for shivering during spinal anesthesia.Egypt J Anesth. 2014;30:31–7.

15- Elsonbaty M, Elsonbaty A, Saad D. Is this time for magnesium sulfate to replace meperidine as an antishivering agent in spinal anesthesia? Egypt J Anesth. 2013;29:213–

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16- Jee DL, Lee DH, Y un SS, Lee CH. Magnesium sulfate attenuates arterial pressure increase during laparoscopic cholecystectomy underpneumoperitoneum. Br J Anaesth.

2009;103:484–9.

17- Gozdemir, M., Usta, B., Demircioglu, R. I., Muslu, B., Sert, H., & Karatas, O. F.

Magnesium sulfate infusion prevents shivering during transurethral prostatectomy with spinal anesthesia: a randomized, double-blinded, controlled study. Journal of clinical anesthesia, 2010: 22(3), 184-189.

18- Sachidananda, R., Basavaraj, K., Shaikh, S. I., Umesh, G., Bhat, T., & Arpitha, B.

Comparison of prophylactic intravenous magnesium sulfate with tramadol for postspinal shivering in elective cesarean section: a placebo controlled randomized double-blind pilot study. Anesthesia, essays and researches, 2018; 12(1), 130.

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