The effect of ondansetron on the reduction of intraoperative shivering during spinal anesthesia of TURP surgery Date: 10/04/2024 | Views: 88

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The effect of ondansetron on the reduction of intraoperative shivering during spinal anesthesia of TURP surgery
Abstract:
Background:
Shivering is one of the many unfavorable side effects of spinal anesthesia that occurs occasionally. Old-age patients receiving spinal anesthetic are more susceptible to hypothermia, which raises the morbidity rate.
Aim of the study:
To determine the effectiveness of ondansetron given just at the time of performed spinal anesthesia, on shivering evoked by spinal anesthesia and, on the incidence of intra-operative shivering, in a randomized, placebo-controlled, double-blinded study, in patients undergoing elective transurethral resection of the prostate (TURP) at Al_Sader teaching hospital in Najaf.
Patient and method:
80 patients, with ASA physical status I and II between the ages of 55 and 83 who were scheduled for elective TURP procedures under spinal anesthesia were divided into two groups at random, the control group received 4 ml normal saline and the ondansetron group received 8 mg ondansetron. As the spinal block was established, the study medications were administered intravenously (IV).
Result:
During spinal anesthesia, ondansetron dramatically decreased the frequency and severity of shivering. Hemodynamic stability is not much altered in the control group as compared to the ondansetron group.
Conclusion:
The incidence and severity of postspinal shivers are greatly decreased by preemptively administering I.V. ondansetron in a dosage of 8 mg at the time spinal anesthesia is performed.
Keywords:
Spinal anesthesia, shivering, TURP, and ondansetron.



Introduction:
Shivering is defined as an involuntary repetitive activity of skeletal muscle. The incidence of shivering is 40-60%, even under spinal anesthesia. (1), Hypothermia is described as a body temperature of 36°C (96.8°F) or lower, and it can be mild (35.0°C-35.9°C), moderate (34.0°C-34.9°C), or severe (33.9°C), (2). Hypothermia during surgery is a major issue in anesthesia practice. Similar to general anesthesia, regional anesthesia affects the body's thermoregulatory system. shivering is the most undesirable side effect of spinal anesthesia.
Depending on how severe it is, shivering can have major implications. Shivering (Grades 1-2) causes a slight increase in oxygen consumption that is comparable to light exercise. A patient's discomfort, an intensification of postoperative pain, a delay in the healing of wounds, an increase in intracranial pressure and intraocular pressure (3), interruption of monitoring (such as pulse oximetry and ECG), interference with the surgeon's work while under spinal anesthesia, (3-4).
Nemours effective medications, such as pethidine (3), tramadol, clonidine (5), ketamine, nefopam (6), ondansetron (7), dexmedetomidine (8), and dexamethasone, can prevent or stop post-anesthesia shivering (9). No anti-shivering medication is suitable. Occasionally, more than one medication is required to treat postoperative shivering.
Ondansetron: A very effective and selective antagonist of the 5 hydroxytryptamine receptor, is frequently utilized as an anti-emetic. (10). The primary purpose of the 5HT 3 receptor antagonist ondansetron is to prevent emesis. In recent times, 8 mg IV of it was effectively used to avoid shivering without any negative side effects. (11). Ondansetron's anti-shivering effect is not fully understood; however, it is thought to work centrally by inhibiting serotonin reuptake at the level of the pre-optic anterior hypothalamus region. (12).
The purpose of this study was to determine the effectiveness of ondansetron given just at time of performed spinal the anesthesia, on shivering evoked by spinal anesthesia and, on the incidence of intra-operative shivering, in a randomized, placebo-controlled, double-blinded study, in patients undergoing elective transurethral resection of the prostate (TURP) at Al_Sader teaching hospital in Najaf.

Method:
The study was performed in AL-Sader Medical City in AL-Najaf AL-Ashraf, operating theatre, during the period from 1st of August 2023 to1th of January 2024, 80 patients were included as follows:
Inclusion criteria: Elective operations of transurethral resection of prostate using cystoscopy under spinal anesthesia with either ASA1 or ASA2.
Exclusion criteria: Emergency operations; a history of sensitivity to the drugs of the ondansetron; having a neuromuscular disease or neurologic disturbances; taking α2 --blocking drugs; having fever or hypothermia; having uncontrolled diabetes mellitus; contraindications to spinal anesthesia and Patients with cardiac, respiratory, and endocrine diseases.
The study was approved by a local committee of the scientific council of Anesthesia & intensive Care, data were enrolled using a pre-constructed form sheet, a detailed history was taken from each patient, and clinical examination was performed by general examination & vital signs measurement.

Patient data collection form
Demographic data:
Name: -----Age: ----- Sex: ---- BMI: ----Medical history: ---- History of previous surgery: ----History of shivering: ---- History of allergy: ---- ASA physical status: -
Blood pressure: ---- Pulse rate: ---- Spo2%: ----Duration of surgery: ----
TEMP: in different periods of time during surgery: ----
BSAS in different periods of time during surgery: ----
The present prospective double-blinded controlled study included 80 patients of the American Society of Anesthesia (ASA) physical status I and II that were to undergo elective TURP surgery and enlisted in this randomized trial. The eighty patients were divided into two equal groups: the first group (40 patients) had received 4 ml of normal saline at the time of preformed spinal anesthesia, and the second group (40 patients) received IV ondansetron at the time of performed spinal anesthesia.
After obtaining ethical acceptance from the Al_Najaf health director and Al_Sader teaching hospital, the patients were admitted to the operation room with a temperature of 70 to 75°F. (21 to 24°C.) and 50 to 60% relative humidity for elective TURP using cystoscopy, all patients are attached to the standard monitoring: ECG, pulse oximeter, temperature prop, and non-invasive blood pressure monitoring. A reading baseline was taken. Then peripheral intravenous access was done using two large bore cannulas, and the crystalloid fluid was given before given spinal anesthesia. Patients lying in the sitting position and their chin on their chest, their hand on their abdomen, under aseptic techniques, patients received 3-3.5 ml of heavy Marcaine of 0.05% under midline approach using cutting spinal needle gage 20, at the time of the applied sub-arachnoid block, patients received either 8 mg (4ml) IV ondansetron in the first group or 4 ml normal saline in the second group (control group).
Systolic, diastolic, SPO2, heart rate, and temperature were recorded, and the bedside shivering assessment score (BSAS) was also documented using BSA score at the following intervals: Before applying spinal anesthesia (baseline), 30, 40, and 50 minutes after performed spinal anesthesia intraoperatively.
Data were entered and analyzed using the statistical package for social sciences (SPSS) software for windows, version 26. Descriptive statistics are presented as mean, standard deviation, frequencies, and proportions (%). The independent sample test and Analysis of Variance (ANOVA) were used to compare the studied groups in categorical variables, while the student’s t-test was used to compare means. The level of significance was set at (≤ 0.05) to be a significant difference or correlation. Finally, the results are presented in tables and figures with an explanatory paragraph for each using the Microsoft Word program version 2016.








Result:
There were 80 patients who come into the operation theater with transurethral resection of the prostate using cystoscopy under spinal anesthesia enrolled in this study assigned into two groups with 40 patients in each, statistically patient demographic (Age, body mass index, and ASA ps classes), operative data (duration of surgery of the two studied groups were comparable, (P > 0.05), (Table 2).
Table (2): Patients' demographic, operative of the two studied groups
Control group Ondansetron group p_ value
N=40 N=40

Demographic details:
Age (years) 68.5±8.6 69.3 ±7.5 0.2

BMI (Kg/m2 ) 24.5±1.7 22.9±1.9 0.63

Operative data:
Duration of surgery 64.8±15.4 64.3±16.9 0.23

ASA ps classification:
ASA ps class I 15 (37.5) 18 (45%)
0.33
ASA ps class II 25(62.5) 22 (55%)
Mean ± Standard deviation
After 30 minutes performed spinal anesthesia, the overall incidences of shivering in each of the ondansetron (1%) groups and control (20%) group were significant (the P< 0.05), in the 40 minutes after performed spinal anesthesia, the overall incidences of shivering in each of the ondansetron (8%) groups and control (41%) group were significant (the P< 0.05), in the 50 minutes after performed spinal anesthesia, the overall incidences of shivering in each of the ondansetron (19%) groups and control (99%) group were significant (the P< 0.05). Control group Ondansetron group P_value
n= 40 n=40
The overall incidence of shivering:
BSAS 30 min after spinal anesthesia n (%) Yes 8 (20%)
No 32 (80%) 1 (1%)
39 (99%) .000
BSAS 40 min after spinal anesthesia n (%) Yes 17 (41%)
No 23 (59%) 6 (8%)
34(92%) .000
BSAS 50 min after spinal anesthesia n (%) Yes 39 (99%)
No 1 (1%) 15 (19%)
25 (81%) .005
The severity of shivering:
BSAS 30 min after spinal anesthesia n (%) Score 0 24 (60%)
Score 1 16 (40%)
Score 2 0 (0%)
Score 3 0 (0%) 39 (99%)
1 (1%)
0 (0%)
0 (0%) 0.000
BSAS 40 min after spinal anesthesia n (%) Score 0 4 (10%)
Score 1 13 (35%)
Score 2 23 (55%)
Score 3 0 (0%) 34 (85%)
6 (15%)
0 (0%)
0 (0%)
0.000
BSAS 50 min after spinal anesthesia n (%) Score 0 0 (0%)
Score 1 3 (8%)
Score 2 32 (80)
Score 3 5 (12%) 25 (63%)
15 (37%)
0 (0%)
0 (0%) 0.000
The severity of shivering in the ondansetron groups was significantly less (P< 0.05) than that in the control group, the incidence of severity of shivering was increased from score 0 to score 3 in the control group as compared with ondansetron group among time, table 3.
Table 4: Mean core body temperature among four times intraoperatively (° c)
Control group Ondansetron group P_Value
Baseline 37±3.8 36.8±43 .795
temp 30 min after spinal anesthesia 36.9±40 36.8±41 .821
temp 40 min after spinal anesthesia 36.6±36 36.6±43 .447
temp 50 min after spinal anesthesia 36.4±33 36.5±42 .821
The two groups' baseline values for core body temperature were statistically equivalent (P > 0.05). During 30, 40, and 50 minutes of the spinal block being administered, the core body temperatures of the two groups fell noticeably below the respective baseline levels (P 0.05). Figure 2 in Table 4.The frequency of diminished systolic blood pressure was equal in both two groups and no Statistically differences were noticeable among the three interval time after performed spinal anesthesia, diastolic blood pressure in the 40 minutes after the spinal block showed static differences, it was still close to baseline in ondansetron group as compared to the control group, table5, figure 3.
Control group Ondansetron group P_value
n= 40 n=40
Systolic baseline 154. ±15.7
145 ±16 .721
Systolic 30 min after spinal anesthesia 138.6± 13
134 ±17.1 0.126
Systolic 40 min after spinal anesthesia 130 ± 11.8
136 ±12.2 0.1
Systolic 50 min after spinal anesthesia 133 ± 9.9
133 ± 9.6 0.67
Diastolic baseline 80 ± 10.4 84 ± 6.7 0.05
diastolic 30 min after spinal anesthesia 74 ± 8.1 72 ± 6.2 0.06
diastolic 40 min after spinal anesthesia 69 ± 6.8
78 ±12.9 0.00
diastolic 50 min after spinal anesthesia 65 ±7.4
67 ± 8.3 0.36

Control group Ondansetron group P_value
n= 40 n=40
Respiratory baseline 14.9 ±1.1
14.2 ±.80 0.05
Respiratory rate 30 min after spinal anesthesia 14.2 ±1.3
14.08 ± .88 0.43
Respiratory rate 40 min after spinal anesthesia 14.08 ±.97
13.7 ±1.3 0.17
Respiratory rate 50 min after spinal anesthesia 14.18± 1.3

13.98 ±1.18 0.47
SPO2 baseline 98.95 ± .74 98.73 ± 1.3 0.36
SPO2 30 min after spinal anesthesia 98.18 ±1.6
98.58 ±1.2 0.22
SPO2 40 min after spinal anesthesia 97.93 ±1.7
98.10 ±2.3 0.7
SPO2 50 min after spinal anesthesia 97.40 ±1.2
97.90 ±1.1 0.5
Control group Ondansetron group P_value
n= 40 n=40
Heart rate baseline 84 ±10.8
96 ±12.8 0.78
Heart rate 30 min after spinal anesthesia 96 ±10.7
94 ±11.7 0.14
Heart rate 40 min after spinal anesthesia 73 ±7.7
86 ±9.4 0.04
Heart rate 50 min after spinal anesthesia 67 ± 6.1
78 ± 9.6 0.01

Discussion:
This study was carried out in the operating room of the Al_Sader Teaching Hospital. Shivering during and after surgery is extremely uncomfortable for the patient and bothersome, and it can cause a number of issues. The prevention and management of intraoperative and postoperative shivering are now just as crucial as the treatment of pain, and a variety of techniques and drugs are employed in this area, however, neither a technique nor a perfect drug has yet been discovered.
In this study, the shivering incidence rate in the control group was (20%, 41%, and 99%) while in the ondansetron group (1%, 8%, and 19%) among three intervals times 30, 40, and 50 minutes after performed spinal anesthesia.
In the present study, a relatively higher incidence of shivering was detected in the control group and found that I.V. ondansetron significantly reduces the incidence and grades of shivering when used as a prophylaxis.
The current investigation found not many observable differences between the tested groups in terms of heart rate, SPO2, respiratory rate, and blood pressure.
These findings are in line with a randomized double-blind cross-sectional research by Javaherforoosh et al. (13), which found no considerable variation in heart rate, blood pressure, or SPO2 between the tramadol (at a dosage of 1 mg/kg) and control groups.
The occurrence of recorded shivering in the control group in Bilotta et al. (14) was 57%, in Kelsaka et al. (15) was 36%, in Sagir et al. (16) it was 55% and in Shakya et al. (17) it was 42.50%. these shivering percentages are somehow equal to our research finding in the 40 minutes, less in the 30 minutes, and higher in the 50 minutes after performed spinal anesthesia. The significantly low prevalence of shivering in the other workers' control group might be related to using of diazepam for premedication which has anti-shivering properties as in the study of Kelsaka et al, and Shakya et al, and different types of patients, anesthesia, and operations in other workers.
From the present study, the detected efficient effects of prophylactic IV administration of each ondansetron at the time of the establishment of spinal block, on reducing the incidence of shivering was in agreement with other workers. Shakya et al. reported that administering 4 mg/kg ondansetron before induction of spinal block can significantly reduce the incidence of shivering (10% compared with 42.5% of control the group).
In the present study, the severity of shivering was significantly higher (P < 0.05) in the control group than in the ondansetron group. These findings were in agreement with other workers’ findings. El Bakry and Ibrahim (18) reported that the severity of shivering was significantly higher (P< 0.05) in the control group than in the dexamethasone group. Badawy and Mokhtar (19) reported that the severity of shivering was significantly higher (P< 0.05) in the control group than in the ondansetron group.
In the present study, the drop of core temperature coexisted with the majority in both groups, control, and ondansetron with no statically differences.
In the present study, there was not much difference between the two groups in relation to hemodynamic parameters. These findings were consistent with previous studies by Kelsaka et al. (20), Shakya et al, and El Bakry and Ibrahim, who found that there was no difference between the groups regarding hemodynamic values.
Conclusion:
In conclusion, Prophylactic administration of I.V of 8 mg ondansetron at the time of performing spinal anesthesia during TURP in older age male patients significantly decreased the severity and incidence of shivering but not intraoperative hypothermia.
Recommendation:
According to the results of our study, I advise anesthesiologists to choose the appropriate ant shivering medication for each of their patients having a TURP surgery until more research is available.
1. Use of I.V. ondansetron at time of performed spinal anesthesia is advised to lessen intra-operative shivering
2. Use of I.V. ondansetron at time of performed spinal anesthesia in various procedures.
The limitations of the present study:
were that the ASA physical status classes I and II and adult patients were the only populations included in the current investigation. Also, each of the tested medications was examined using a single fixed dosage.
Conflict of interest:
None declared.