|Year : 2022 | Volume
| Issue : 1 | Page : 3-8
Prophylactic intravenous dexamethasone versus dexmedetomidine for postspinal shivering during lower segment cesarean section: A prospective randomized, double-blind study
Pratibha Jain Shah, KP Ummu Habeeba
Department of Anaesthesia and Critical Care, Pt. JNM Medical College, Raipur, Chhattisgarh, India
|Date of Submission||20-Jan-2022|
|Date of Acceptance||22-Mar-2022|
|Date of Web Publication||20-May-2022|
Dr. Pratibha Jain Shah
Department of Anaesthesia and Critical Care, Pt. JNM Medical College, Raipur, Chhattisgarh
Source of Support: None, Conflict of Interest: None
Introduction: Shivering is one of the most common encountered little big problems with spinal anesthesia. There are only few published studies comparing intravenous (iv) dexamethasone and dexmedetomidine for the prevention of postspinal shivering (PSS). Aim: The aim of the study is to compare the effectiveness and safety of iv dexamethasone and iv dexmedetomidine in the prevention of PSS during lower segment cesarean section. Methods: Total 160 parturients were randomly allocated into 2 groups by a Sequentially Numbered Opaque Sealed Envelope technique, namely Group Dx and Dm (n = 80). Group Dx received iv dexamethasone 0.1 mg/kg whereas Group Dm received iv dexmedetomidine 1 μg/kg. Incidence of shivering and shivering score were the primary outcomes and the secondary outcomes were sedation score, level of blockade, duration of surgery, axillary temperature, adverse effects, Apgar score, and hemodynamic parameters. Results: Incidence of shivering was significantly low in dexmedetomidine compared to dexamethasone (13.75% vs. 31.25%; P = 0.00468). Group Dx also had comparatively higher shivering score. Overall incidence of sedation was higher in Group Dm compared to Group Dx (15% vs. 3.75%; P = 0.0022). Five parturients in Group Dm (6.25%) had bradycardia compared to none in Group Dx. Respiratory rate, oxygen saturation, and Apgar score were statistically comparable between the 2 Groups. Conclusion: iv dexmedetomidine is more effective in preventing PSS compared to dexamethasone. Additional sedation with dexmedetomidine aids more comfort to the parturients.
Keywords: Dexamethasone, dexmedetomidine, shivering, spinal, temperature regulation
|How to cite this article:|
Shah PJ, Ummu Habeeba K P. Prophylactic intravenous dexamethasone versus dexmedetomidine for postspinal shivering during lower segment cesarean section: A prospective randomized, double-blind study. J Ind Coll Anesth 2022;1:3-8
|How to cite this URL:|
Shah PJ, Ummu Habeeba K P. Prophylactic intravenous dexamethasone versus dexmedetomidine for postspinal shivering during lower segment cesarean section: A prospective randomized, double-blind study. J Ind Coll Anesth [serial online] 2022 [cited 2022 Jul 1];1:3-8. Available from: https://www.jicajournal.in//text.asp?2022/1/1/3/345604
| Introduction|| |
Shivering is defined as an “Oscillatory, involuntary mechanical muscular activity and natural protective mechanism for the reduction of body temperature.” This little big problem is annoying complication of regional as well as general anesthesia. The reported incidence of shivering with regional anesthesia is 56.7% and almost 85% of the patients who underwent spinal anesthesia had shivering.
Factors such as uninhibited spinal reflexes, postoperative pain, decreased sympathetic activity, pyrogen release, adrenal suppression, and respiratory alkalosis have been suggested to contribute for the development of shivering in the perioperative period. Apart from these, spinal anesthesia produces vasodilatation, which facilitates core to peripheral redistribution of heat. It also increases sweating threshold and decreases vasoconstriction and shivering threshold. Intrathecal block will decrease the temperature by 0.5°C.
The shivering increases heat production up to 600% and oxygen consumption thrice. Shivering will also lead to increased production of carbon dioxide, increase risk of myocardial infarction, infection, bleeding, increased minute ventilation, hypoxemia, lactic acidosis, raised intracranial pressure, and intraocular pressure. It also impedes the electrocardiogram (ECG), noninvasive blood pressure (NIBP), and oxygen saturation (SpO2) monitoring because of involuntary muscular activity.
There are no single gold standard preventive and treatment measures for postanesthetic shivering and still there is an expedition for the same. The evidence on the effectiveness of prophylactic intravenous (iv) dexamethasone and dexmedetomidine for postspinal shivering (PSS) in parturient are very scarce. Hence, this prospective double-blind interventional study is planned with the aim to evaluate and compare the efficacy and safety of iv dexamethasone and dexmedetomidine during caesarean section for prevention of perioperative shivering. The primary outcomes of this study were incidence of shivering and shivering score and the secondary outcomes were sedation score, level of blockade, duration of surgery, changes in axillary temperature, adverse effects, Apgar score, and hemodynamic parameters.
| Methods|| |
The present prospective randomized double-blinded study was carried out at Tertiary Center Teaching Hospital after approval from Institutional Scientific and Ethics Committee and registration in Clinical Trials Registry of India (CTRI/2020/01/030303) from November 2020 to April 2021. The study was conducted as per consort guidelines and followed ethical guidelines of the Declaration of Helsinki. After written informed consent to participate in the study, 160 parturients of 18–45 years of age, weighing 40–100 kg, height 135–180 cm, American Society of Anaesthesiology Physical Status II, singleton term pregnancy for emergency/elective cesarean delivery under SAB were included in the study. Parturient refusal to participate, any contraindications to spinal anesthesia, insufficient blockade required supplementation of anesthesia, any comorbidities like cardiovascular or cerebrovascular diseases, renal impairment, severe liver diseases, hypo or hyperthyroidism, convulsion or psychiatric disorders, complicated pregnancy like eclampsia, allergy to dexamethasone, dexmedetomidine or bupivacaine, novel corona virus positive, known history of substance abuse or alcohol abuse, initial temperature of >38.0°C or <35.0°C, and blood transfusion during surgery were excluded from the study.
For sample size calculation, a pilot study was conducted in 40 parturients who were equally distributing among dexamethasone group and dexmedetomidine group due to the lack of previous study comparing these two drugs in parturients for prevention of shivering. We observed 30% incidence of shivering in dexamethasone group compared to 10% in dexmedetomidine group. Taking these into consideration, with confidence level of 95% and power of 80%, minimum sample size of 72/group was required to compare the effect of both the drugs as calculated using Epitool, developed and maintained by AUSVET, Bruce ACT, Australia.
A total of 194 parturients were assessed for eligibility and 33 were excluded since not meeting the inclusion criteria or tumbled in exclusion criteria. A consolidated standard of reporting trials flow diagram is depicted in [Figure 1]. Randomization was done with Sequentially Numbered Opaque Sealed Envelope Technique of 1:1 into 2 Groups by resident anesthesiologist who is not involved in the intraoperative management. Total 160 slips which was labeled either dexamethasone or dexmedetomidine were sealed with an adhesive and placed in a container. If a parturient got excluded after randomization, the card chosen by her is dropped back into the container. Dexamethasone and dexmedetomidine were prepared and diluted in a 10 ml syringe and coded by the same anesthesiologist. Group Dx and Group Dm received bolus iv dexamethasone (0.1 mg/kg) and dexmedetomidine (1 μg/kg) prophylactically just after the intrathecal injection for prevention of PPS, respectively. The chosen doses of dexmedetomidine and dexamethasone in the current study were based on the reference publications by Botros et al. and Ali et al. respectively. Due to the lack of literature that compared these two drugs directly, the doses were taken from two different studies that evaluated anti-shivering effect of dexmedetomidine and dexamethasone separately. Botros et al. randomly allocated 120 patients into 3 groups (n = 40) and compared 8 mg ondansetron, 1 μg/kg dexmedetomidine, and normal saline in respect to their effect on incidence and severity of PSS. While in study conducted by Ali et al., 90 patients were allocated randomly to one of three equal groups (n = 30) and compared 0.25 mg ketamine with 40 μg/kg midazolam, 0.1 mg/kg dexamethasone, and normal saline with respect to their effect on incidence and severity of PSS.
Parturients and anesthesiologist involved in the intraoperative management were blinded to the type of study drug injected and group allocation.
All parturient were fasted for 6 h before operation/with aspiration risk consent in view of emergency if fasting guidelines are not fulfilled. On arrival to the operation theatre, 18G iv cannula was accessed and multipara monitors were attached and baseline heart rate (HR), NIBP, peripheral SpO2, and ECG were recorded. Apart from these, axillary temperatures were also noted. Prehydration was done with 500 ml RL which was kept at room temperature. The operation room temperature was maintained at 25°C. All parturients were covered with 2 layers of surgical drapes over chest, thighs, and calves with foot during the operation and then one cotton blanket over the entire body postoperatively.
Subarachnoid space was accessed under all aseptic precaution through L3–L4 or L4–L5 intervertebral space using 25 G/26 G Quincke's spinal in left lateral decubitus position. After confirmation of free flow of cerebrospinal fluid, 2 ml hyperbaric bupivacaine 0.5% (w/v) was administered in subarachnoid space to achieve block up to T4. Just after the intrathecal injection, one of the study drugs was given slowly by iv route over 5 min.
Hemodynamic parameters (HR, systolic blood pressure [SBP], diastolic blood pressure [DBP], SpO2, respiratory rate [RR]), incidence and grade of shivering, and degree of sedation were recorded in every 2 min interval till 20 min and thereafter every 5 min interval till the completion of surgery. Axillary temperature was recorded before blockade and at 5 min interval till the end of surgery.
Shivering was graded based on Tsai and Chu 5-point score; where Score 0 = No shivering, Score 1 = Piloerection, peripheral vasoconstriction but no visible shivering, Score 2 = Muscular activity of 1 muscle group, Score 3 = Muscular activity of more than 1 Group of muscles but not generalized, and Score 4 = Shivering whole body. A rescue drug 1 mg/kg tramadol was administered if continuous shivering score of ≥3 was persisting for more than 15 min.
The degree of sedation was graded on a 4-point scale as per Filos et al. where Grade 1 = Awake and alert, Grade 2 = Drowsy, responsive to verbal stimuli, Grade 3 = Drowsy, arousable to physical stimuli, and Grade 4 = Unarousable.
Neonatal outcome was assessment by APGAR score at 1st and 5th min after birth.
Hypotension was defined as decrease in mean arterial pressure of more than 20% of baseline value and was treated with bolus iv injection of mephentermine (6 mg).
Bradycardia, a fall in HR below 50 beats/min was treated with iv atropine 0.6 mg.
Over sedated/sedation score ≥3 with hypoxemia (SpO2 <92%) was considered for intensive care unit admission.
Nausea, vomiting, headache, allergy, pruritus, total spinal block, and other maternal undesired effects were noted and managed accordingly.
Statistical analysis was done with Microsoft Excel 365 data analysis tools. Numerical variables were compared between the groups by Students unpaired t-test and within the group by students paired t-test. Categorical data were compared between the groups by Chi-square test. P ≤ 0.05 was considered as significant.
| Results|| |
Demographic data of parturients, level of blockade, duration of surgery, and Apgar scores of neonates were statistically comparable between the groups [Table 1]. Level of blockade was T4-T5 in majority of the parturients.
Incidence of shivering was significantly low in Group Dm (11 parturients, 13.75%) as compared to Group Dx (25 parturients, 31.25%) [Figure 2]. Overall parturients in Group Dm had lower shivering score compared to Group Dx, even though shivering persisted for longer duration in Group Dm [Figure 3].
|Figure 3: Distribution of parturient in various shivering scores at various time intervals|
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The incidence of sedation was statistically high in Group Dm as compared to Group Dx (P = 0.0022) [Figure 4].
|Figure 4: Distribution of parturient in various sedation scores at various time intervals|
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SBP, DBP, and HR were significantly low in Group Dm compared to Group Dx [Figure 5].
In both the groups, RR, SpO2, and axillary temperature were comparable in all measured time intervals with a mean of 16–17 breaths min, 97% to 100% and 36.5°C–36.7°C, respectively.
Incidence of complications such as nausea, vomiting, pruritus, headache, high spinal/total spinal, hypotension, and bradycardia is depicted in [Figure 6].
| Discussion|| |
As concerns to the current study, both dexamethasone and dexmedetomidine were found to be effective to impede PSS. The incidence of shivering and shivering score was significantly low in Group Dm compared to Group Dx, however, shivering persisted for shorter duration in Group Dx. The incidence of sedation was high in Group Dm as compared to Group Dx. In Group Dm, there was a significant decrease in HR, SBP, and DBP compared to Group Dx. In both the groups, RR, SpO2, and axillary temperature were comparable at all measured time intervals.
The incidence of shivering was significantly low in Group Dm (13.75%) compared to Group Dx (31.25%). Similar incidence of shivering was observed by Ismaiel et al., i.e., 23.33% in dexamethasone and 16.6% in dexmedetomidine group. Although they compared the same study drugs (dexmedetomidine 5 μg and dexamethasone 8 mg), it was administered intrathecally along with 12.5 mg 0.5% bupivacaine heavy. Similar incidence of shivering (31.1%) was observed with iv dexamethasone (0.6 mg/kg) in elective surgeries under general anesthesia in the study done by Zavareh et al. Usta et al. also got similar results of incidence of shivering after iv dexmedetomidine (1 mcg/kg), i.e., 10% under spinal anesthesia. Slightly higher incidence of shivering (43.8%) was reported by Destaw et al. after administration of iv dexamethasone compared to our study. This might be because they conducted their study in geriatric population undergoing transurethral resection of the prostate under spinal anesthesia. Botros et al. noted 27.5% incidence of shivering following iv dexmedetomidine in patients undergoing elective nonobstetric procedures. This higher incidence could be due to administration of higher doses of intrathecal bupivacaine (3 ml of 0.5% heavy) and difference in the demographic profile compared to the current study. In the present study, overall parturients in Group Dm had lower shivering score compared to Group Dx. Although shivering persisted for longer duration in Group Dm, it was of score 1 only. Ismaiel et al. also noted a decrease in shivering intensity with both dexmedetomidine and dexamethasone, but intrathecal dexmedetomidine was more superior. Usta et al. did not observe more than Grade 3 shivering after iv dexmedetomidine. El Bakry and Ibrahim noted significantly lower intensity of shivering after iv dexamethasone and pethidine compared to control group. They observed Grade 1 shivering in 16.6% and Grade 2 shivering in 3.33% following iv dexamethasone. These results are in line with the current study.
The present study showed overall significantly higher incidence of sedation after iv dexmedetomidine compared to dexamethasone. Ismaiel et al. noted Grade 1 sedation in 50%, Grade 2 in 43.33%, and Grade 3 in 6.66% parturients after dexmedetomidine compared to Grade 1 sedation in just 20% parturients after dexamethasone and none of the parturients had Grade 4 sedation in any of the groups. These additional sedative properties of dexmedetomidine were found to be beneficial for both parturients and surgeons.
With regard to side effects, incidence of nausea, vomiting, pruritus, and headache were 2.5%, 1.25%, 5%, and 7.5%, respectively, in Group Dx as compared to 3.75%, 2.5%, 10%, and 6.25%, respectively, in Group Dm. None of the parturients in either of the group had any episode of high spinal or total spinal. Sixteen parturients (20%) in Group Dx developed hypotension as compared to 29 parturients (36.25%) in Group Dm. (P = 0.0223). In Group Dx, 16 parturients (n = 20, i.e., 20% of sample size) received iv mephentermine in various doses (minimum of 3 mg to maximum of 18 mg) while in Group Dm, mephentermine consumption (minimum 3 mg to maximum 30 mg) was higher with a total of 29 parturients (n = 29, i.e., 36.25% of sample size). None of the parturients in Group Dx developed bradycardia, wherein 6.25% parturients (n = 5) in Group Dm developed bradycardia (P = 0.0244). Ismaiel et al. reported 80% incidence of hypotension in dexmedetomidine group and 83.3% in dexamethasone group. They also handled 10% and 6.6% of bradycardia incidences in dexmedetomidine group and dexamethasone group, respectively. Incidence of nausea and vomiting was 6.6% and 10% in dexmedetomidine group and dexamethasone group subsequently. The administration of higher dose of bupivacaine (12.5 mg 0.5% heavy) and utilization of different route (intrathecal dexmedetomidine and dexamethasone) could have contributed for this higher incidence of hypotension in their parturients.
There were few limitations of the current study, like the study duration was limited till the end of surgery which could have been extended till the passing off effect of SAB, usage of mephentermine injection during hypotensive episodes which was one of confounding factors, limited availability of similar studies for comparison, and lack of core temperature monitoring since the study was conducted during restrictions imposed period of COVID-19 pandemic.
In the future, a comparative study of the same drugs can be done among nonparturients patients undergoing surgery under spinal anesthesia and for extended duration. Since anti-shivering properties of the study drugs for longer surgeries would be more practical and conclusive because of high risk of hypothermia in such surgeries, Besides Apgar score, umbilical blood analysis can be done to know the effect of drugs on neonates.
| Conclusion|| |
Prophylactic iv injection of both dexamethasone (0.1 mg/kg) and dexmedetomidine (1 μg/kg) is effective in reducing PSS during cesarean section. However, dexmedetomidine is found superior to dexamethasone in terms of its effect on incidence and severity of severing during lower segment cesarean section. In addition, dexmedetomidine also provides good sedation, which equally benefits surgeon and parturients. The complications reported with dexmedetomidine were less and easily treatable and did not have much clinical impact.
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Conflicts of interest
There are no conflicts of interest.
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