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Table of Content - Volume 20 Issue 3 - December 2021
Sajidhusain B N1*, Faizan A B2
1Department of Anaesthesiology, Belgaum Institute of Medical Sciences, B R Ambedkar Road, Belgaum, Karnataka-590001, INDIA. 2Ph.D. Research Scholar, Department of Pharmacology and Toxicology, KLE College of Pharmacy, A Constitute Unit of KLE Academy Higher Education and Research, Belagavi-590010, INDIA. Email: sajidnadaf@gmail.com
Abstract Background: As it is cost-effective, easy to give, has a quick onset of action, and has fewer side effects, spinal anaesthesia is preferred for urological procedures. Nevertheless, it has the disadvantages of a shorter block length, no postoperative analgesia recommendation, and post-spinal shivering. The current study administered intrathecal Dexmedetomidine and intrathecal Magnesium Sulphate (MgSO4) to prevent shivering following spinal anaesthesia during urological procedures. Aim: The researchers aim was to see how intrathecal Dexmedetomidine compared to Intrathecal Magnesium sulphate for preventing post-spinal anaesthetic shivering. Material and Methods: The current study was a hospital-based, comparative examination of patients aged 21–70 years who were scheduled for elective urological surgery under spinal anaesthesia and had an ASA physical grade of I or II. Shivering was given a score that was confirmed by Crossley and Mahajan. Results: In both groups, Age (years), Gender (male or female), BMI (Kg/m2), ASA grade, duration of surgery (min) and baseline axillary temperature were comparable between both groups, and there was no statistically significant difference seen among both the groups. When comparing groups D and M, we found that group D had a faster start of sensory and motor blocks and a longer duration of sensory and motor blocks, which was statistically and clinically significant. Shivering was found to be more common in group M (20%) than in group D (16.67%) in the current investigation, but the difference was not clinically significant. Hypotension, nausea, and vomiting were more common in group M than in group D, but the difference was not statistically significant. Conclusion: In urological operations, Dexmedetomidine or Magnesium sulphate used as an adjuvant with hyperbaric bupivacaine had a similar effect in avoiding shivering. Keywords: Dexmedetomidine, Magnesium sulphate, Spinal anaesthesia, post-spinal shivering.
INTRODUCTION Urology surgery is the leading cause of mortality all around the world. It has a tremendous cost in terms of lives, productivity, and money, but it also has a significant cost in terms of physical suffering and mental misery for sufferers. Major advancements in the management of Urology surgery have been made in recent years, resulting in lower mortality and functional improvement. One of these is palliative care. Improved pain management and side effects for blunt lower extremity urological surgeries has been demonstrated to minimise morbidity, arising from the presence ambulation, and enhance long-term conditions. As a result, effective pain management is critical for facilitating rehabilitation and accelerating functional recovery, encouraging patients to return to their previous level of activity faster. Spinal anaesthesia (SA) is a very safe and efficient approach for brief procedures, especially when patient consciousness must be retained to detect intraoperative complications. For urological procedures, spinal anaesthetic is favoured because it is cost-effective, easy to administer, has a quick commencement of action, and has minimal side effects. However, it has limitations, such as a shorter timestamp, no postoperative analgesia, and post-spinal shivering.1 Polypharmacological approach is the most common practice to treat perioperative pain, as no single agent has yet been identified to specifically inhibit nociception without associated side effects.2Shivering has a range of negative repercussions. It interferes monitoring, elevates circulating catecholamine, heart rate, cardiac output, minute ventilation, patient oxygen intake, metabolic aerobic respiration, lactic acid production, intracranial and intraocular pressure, and postoperative pain from incisions and strain.3 To stop shivering, many opioid and non-opioid medications such as Meperidine, Ketamine, Tramadol, and Clonidine have been attempted, but they seem to have a lot of side effects, and the results just weren't satisfactory.4 Dexmedetomidine is an alpha 2-adrenergic receptor agonist that induces anxiolysis and analgesia (including spinal and supraspinal locations) due to central alpha 2-adrenergic receptor activation in the locus coeruleus. It has been proven useful intravenously for the treatment and prevention of a host of symptoms.5The inorganic salt Magnesium Sulphate (MgSO4) has been demonstrated to inhibit postoperative shivering, demonstrating that the medication decreases the shivering threshold. Magnesium sulphate is also employed as an anti-shivering agent its effect is thought to be owing to a central action.6 The current study compared Intrathecal Dexmedetomidine with Intrathecal Magnesium sulphate for the prevention of post-spinal anaesthetic shivering in urological surgery at a tertiary hospital. The occurrence and severity of shivering were the key outcomes. The occurrence of problems, such as hypotension, bradycardia, nausea, and vomiting, as well as the secondary outcomes of hemodynamic parameters.
METHODS The study was a randomised, hospital-based, comparative study and was conducted at the departments of anaesthesiology in a tertiary care hospital for a period of one year (August 2020 to July 2021). With the signed consent of subjects undergoing operative procedures and receiving both intrathecal Dexmedetomidine and intrathecal magnesium sulphate, they were considered for the study. A total of n=60 subjects were enrolled based on the inclusion criteria, making the final tally n=60 subjects with a 100% completion rate. Inclusion criteria: Patients aged 21–70 years old, of either gender, with an ASA physical grade of I/II who are scheduled for elective urological surgery under spinal anaesthetic and are willing to participate in the study. Exclusion criteria: Patients with severe heart, kidney, liver, or metabolic disorders. Thyroid or Parkinson's disease patients. Patients receiving vasodilators or medications likely to alter thermoregulation. Patients with contraindications to spinal anaesthesia, Patients who are allergic to the study medicine. Patients have contraindications to spinal anaesthesia. Patients with a failed or incomplete SAB. Patients were assigned to either the control or interventional group through a concealed allocation method. The control group (subject and the guardian) received normal medical care, while in the experimental/intervention group, the guardians were provided with verbal and written information about anaesthesia surgery, its benefits, harms, and on-going needs. In India, the current status of scientific progression in the field, etc., along with physician consultation and their counselling, Patient counselling on generalised health, as all patients underwent history taking, present symptoms, and past medical/surgical history, were evaluated for routine investigations, and posted for surgery after anaesthetic fitness. In the pre-anaesthesia room, an IV system was set up, and preloading with intravenous isotonic saline solution at 10 ml/kg was done. In the operating theatre, ECG, oxygen saturation, and non-invasive blood pressure monitors were all monitored. The operating room (OT) temperature was regulated between 22 and 24 degrees Celsius. At random, patients were given either Dexmedetomidine (group D) or Magnesium sulphate (group M). Patients in group D received 2.5 ml of 10% hyperbaric Bupivacaine in 0.5 ml of normal saline along with 10 gm of preservative-free Dexmedetomidine. 2.5ml of % hyperbaric bupivacaine/12.5mg and 25mg of magnesium sulphate were given to patients in group M. With all aseptic precautions, a 25 G spinal needle was used to execute a subarachnoid block at the L3–L4 or L4–L5 intervertebral spaces. A face mask was used to supply oxygen (5L/min) during the surgery. The sensory level of the block was determined to be above T10 dermatome after spinal anaesthesia using a pin-prick test (needle prick). A thermometer was used to record the axillary temperature upon entering the operating theatre, and it was thereafter measured at 15-minute intervals. Warming cabinets were used to warm all irrigating and intravenous fluids to 37 degree Celsius. During the procedure, all patients were draped in a single piece of surgical drape over their chests, thighs, and calves. After spinal anaesthesia, the attending anaesthesiologist documented the time in minutes when shivering began (onset of shivering), the severity of the shivering, the time it took for the shivering to stop, and the response rate (shivering ceasing within 15 min after treatment). Shivering was graded with a score validated by Crossley and Mahajan.7 Table
Patients were given intravenous tramadol (0.5 mg/kg IV) if they shivered with a shivering score of 3 or higher. In the post anaesthetic care facility, all patients were draped with a single layer of drapes and a cotton blanket after surgery (PACU). PACU was kept at a constant temperature of 25-26 °C. Various indicators (heart rate, mean arterial blood pressure, oxygen saturation, core body temperature, and shivering scores) were monitored in the PACU at 15-minute intervals during the first 6 hours after surgery. Any significant changes, such as bradycardia, hypotension, nausea and vomiting, and TURP syndrome (blurring of vision, agitation, confusion, convulsions, and other symptoms), were documented and treated as appropriate. The total volume of irrigation solution used for each patient had been documented by the end of the surgery. ETHICS APPROVAL AND CONSENT TO PARTICIPATE We further confirm that any aspect of the work covered in this manuscript that has involved human participants has been conducted with the ethical approval. HUMAN AND ANIMAL RIGHTS No animals were used for studies that are base of this research. The study on humans was conducted in accordance with the ethical rules of the Helsinki Declaration and Good Clinical Practice.
STATISTICAL ANALYSIS The data was collected offline and then sorted and organised into clinical and demographical data sections for both the control and experimental groups using Microsoft Excel. The data was analysed using SPSS v23.0. For categorical data, frequency, percentage, mean, and standard deviations (SD) were calculated, whilst ratios and proportions were also calculated. The chi-square test or Fisher exact test were utilised to see if there was a difference in proportions across qualitative variables. P-value of <0.05 was considered statistically significant. The qualitative variables were represented as frequencies and percentages, whereas the quantitative data were presented as ranges and means plus standard deviations Numbers and percentages were used to represent ASA grade and sex. Means and standard deviations were used to represent age, height, weight, and the onset and duration of sensory and motor blocks. As figures and percentages, the incidence of shivering, ASA grades, and complications were displayed.
RESULTS A total of n=60 subjects were enrolled in the study out of a total of n=90 subjects screened, and all of them finished it, resulting in a 100% completion rate. N=60 patients posted for various urological surgery were randomly allocated into group D (received 10 µgm preservative-free Dexmedetomidine) and group M (received 25mg of Magnesium sulphate). Above drugs were given as an adjuvant to 2.5 ml of hyperbaric bupivacaine 0.5%, intrathecal. In both groups, Age (years), Gender (Male/Female), BMI (Kg/m2), ASA grade, Duration of surgery (min) and baseline axillary temperature were comparable between both groups and no statistically significant difference was noted among them. Out of n=90 subjects screened total 60 subjects were enrolled in the study of which all completed the study making 100% completion rate. The Age of the subject enrolled were 50.9±10.5 years in Group D and 51.2±10.9, the age was seen normally distributed among both the groups. Similarly, the BMI of the subjects enrolled were normal and was in the range of 24.1±3.1 in highest in Group D. Out of n=60 subjects enrolled n=26 are male and n=4 are female in Group D, followed by n=27 are male and n=3 are female in Group M. The variable gender is not significantly associated with control group or Intervention group but there is significant age difference between control group and Intervention group as shown in Table no 1. ASA Grade I is seen highest in Group M with 21 frequencies, and Grade II is seen in Group D with 10 frequencies. As duration surgery and it effects was seen significant with Group M as 104.1±40.2 more effective and Group D with 102.2±39.7 respectively. Further, Baseline axillary temperature was seen normal in both groups with minimal changes which can be noted as equally distributed as shown in Table no 1. In comparison with the Group D and Group M, onset of sensory and motor block is highest in Group M as 6.33 ± 3.01 as <0.001 with p-value<0.05 which is clinically and statistically significant. Similarly, to that of Onset of motor block which shows highest in Group M as 8.34 ± 3.19 as <0.001 with p-value <0.05 which is clinically and statistically significant as in both condition Group M shows good optimal results in comparison with Group D. Further, comparison with the Group D and Group M. Duration of motor block and Duration of sensory block seen to be highest as 202.52±30.45, 241.73 ± 38.93 as<0.001 with p-value <0.05. As group D seen to be is clinically and statistically significant respectively as shown in Table no 2. In this study, shivering was more common in group M than in group D as Perioperative Shivering grade, with Grade III is seen in Group M with n=5 (16.67%) is highest when compared with Group D as n=4 (13.33%) with Grade IV is seen equal in both groups with n=1 (3.33%) respectively, as the difference was not clinically but statistically significant as 0.081 with p-value<0.05. Group M had a higher side effects of Hypotension n=5 (16.67%) followed by Bradycardia n=3 (10%) and least with nausea and vomiting n=2 (6.67%). Similarly in connection with Group D which showed Hypotension n=4 (13.33%) followed by Bradycardia n=3 (10%) and least with nausea and vomiting n=1 (3%) respectively. As the difference was not clinically but statistically significant as 0.073 with p-value<0.05 shown in Table no 3.
Table 1: General characteristic
Table 2: Spinal anaesthesia characteristics
Table 3: Incidence of side effects
DISCUSSION Spinal Anaesthesia has an additional benefit in urological treatments in addition to its well-known benefits. However, SA is not a risk-free procedure; shivering is a typical complication of SA, although this occurs less frequently in people who undergo the operation. Shivering is a protective mechanism to maintain body heat, but it causes discomfort and pain in patients with impaired cardiovascular reserves or limited respiratory capacity, as it increases circulating catecholamine, HR, cardiac output, minute ventilation, oxygen consumption, metabolic CO2 production, and lactic acid level. Due to surgical incision stretching, it also elevates intraocular and intracranial pressure, as well as postoperative pain. Shivering can potentially impair patient monitoring by generating aberrations on the ECG or interrupting blood pressure and pulse oximetry measurements.8 Shivering in patients with ASA grades III and IV might also make surgery more difficult for the surgeon and lengthen the procedure. Spinal anaesthesia inhibits vasoconstriction below the level of anaesthesia by somatic and sympathetic blocking, resulting in vasodilation and increased cutaneous blood flow, resulting in greater heat loss through the skin. Shivering is a common occurrence during SA, although the exact mechanisms that cause it have yet to be discovered. Central thermoregulation disturbance, internal body heat redistribution, and body heat loss to the environment are all possible processes.9 The anti-shivering effect of magnesium sulphate could very well be due to NMDA receptor blockade, which reduces norepinephrine and 5-HT, both of which are implicated in thermoregulation, or it could be due to calcium antagonist action, as MgSo4 has a mild peripheral muscle relaxation effect which might reduce shivering intensity,10 or as a result of peripheral vasodilation, which causes enhanced cutaneous circulation and a decrease in shivering.11 Shivering after surgery is reduced by premedication with IM Dexmedetomidine.12 A modest number of studies evaluating the efficacy of intrathecal Dexmedetomidine for the prevention of shivering in TURP patients have found that Dexmedetomidine reduced the incidence of postoperative shivering.13 In prior studies, the combination of Dexmedetomidine and MgSO4 successfully prevented and controlled spinal anaesthesia-induced shivering.14,15The anti-shivering effect of Dexmedetomidine may be attributed to the inhibition of vasoconstriction and shivering thresholds, as well as the modulation of central thermoregulatory control via neuronal conductance restriction.14In our study n=60 were enrolled patients and randomly assigned in group D were given 2.5 ml of 0.5 % hyperbaric Bupivacaine with 10 gm. preservative free Dexmedetomidine in 0.5 ml of normal saline. Patients in group M were given 2.5ml 0.5% hyperbaric bupivacaine /12.5mg + 25mg magnesium sulphate which shows Dexedetomidine Intrathecal injections were found to be effective in reducing shivering following spinal anaesthesia. For Group D as Perioperative Shivering grade with III and IV 5 (16.67%) and 1 (3.33%) and Group M 4 (13.33%) and 1(3.33%) respectively. Similarly, a randomized, double-blinded study carried by Omar H. et al.15 n=105 patients scheduled for uroscopic surgery were randomly assigned to Group C (n = 35, 2.5 ml of hyperbaric bupivacaine 0.5% /12.5mg), Group M (n = 35, 2.5ml of hyperbaric bupivacaine 0.5 % /12.5mg + 25mg of MgSO4), and Group D (n = 35 ,2.5ml of hyperbaric bupivacaine 0.5%/12.5mg + 5 μg of Dexmedetomidine). Group C had vastly larger proportions of patients experiencing shivering (21), developed grade IV shivering (20), and required Meperidine (21) for shivering treatment than groups M (8,5,5) and D (5,3,6), which were equivalent. They determined that both Dexmedetomidine and MgSO4 intrathecal injections were efficacious in lowering the incidence of shivering after spinal anaesthesia. Shivering is caused by a complicated network of neurotransmitter routes, each with its own set of receptors. Different medicines that act on these receptors to prevent or cure shivering following SA. Because shivering is a major problem in all aspects, n=60 were assigned to group D. We found that group D had an earlier onset of sensory and motor block, as well as a longer duration of sensory and motor block, when compared to group M. Shivering was also more common in group M than in group D. Group D (n=30) exhibited Grade III 4 (13.33 %), Grade IV 1 (3.33 %), and Group M (n=30) experienced Grade III 5 (16.67 %), Grade IV 1 (3.33 %) perioperative shivering, respectively. The results are similar to Jain K et al.,16 in various infraumbilical surgeries, n=120 subjects were randomly assigned into Group D (n = 60, received Dexmedetomidine 5 µg) and Group M (n = 60, received Magnesium sulphate 75 mg). Shivering was observed in 4 (6.6%) patients in Group M whereas 6 (10%) patients in Group D; (P > 0.05). Shivering is caused by hypothermia, however there is no clear association between body temperature and the occurrence of shivering. Age, the extent of sensory block, the operating room temperature, and the temperature of the IV solutions are all key risk factors. As in the present study it is seen most common in Group M (20%) and D (16.64%) respectively. Similar to the study carried out by Shahi V et al.17 studied n=125 patients undergoing lower limb surgeries. Patients were randomly assigned either MgSO4 (Group M) or Dexmedetomidine (Group D) along with epidural bupivacaine for surgical anaesthesia. Shivering was observed in all three groups; however, it was more common in Group D (30%) than in Group M (10%). The probable mechanism of hypothermia could be thermal redistribution from the central to the peripheral region after local epidural anaesthetic injection.
CONCLUSION Dexmedetomidine and MgSO4 intrathecal injections with bupivacaine were found to be beneficial in preventing Post-SA shivering. A common side effect of spinal anaesthesia is shivering. Its cause is unclear, and there is no recognised treatment for it. In urological surgery, however, we observed that adding Dexmedetomidine or Magnesium Sulphate as an adjuvant with hyperbaric bupivacaine to reduce post-spinal anaesthetic shivering had a substantial influence. Dexmedetomidine is a preferred choice because of its additional benefits during spinal anaesthesia.
LIMITATIONS The current study has some limitations, such as a limited sample size and no monitoring of core temperature. As a result, more research is needed to compare Dexmedetomidine to Magnesium Sulphate as the recommended anti-shivering medication.
ACKNOWLEDGEMENTS We explicit our heartfelt gratitude to our honourable Principal, Belagavi Institute of Medical Sciences, Belagavi, teaching and non-teaching faculty members of Department of Anaesthesiology and also, all the subjects enrolled in our study for their valuable time and co-operation without which this study would not have been feasible.
REFERENCES
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