|Year : 2016 | Volume
| Issue : 2 | Page : 319-323
Role of butorphanol and ondansetron premedication in reducing postoperative shivering after general and spinal anesthesia: A randomized comparative study from North India
Sujeet Rai1, Satyajeet Verma2, HP Pandey1, Pramod Yadav3, Amit Patel4
1 Department of Anaesthesia, MRA Medical College, Ambedkar Nagar, Uttar Pradesh, India
2 Department of General Surgery, MRA Medical College, Ambedkar Nagar, Uttar Pradesh, India
3 Department of ENT, MRA Medical College, Ambedkar Nagar, Uttar Pradesh, India
4 Department of Ophthamology, MRA Medical College, Ambedkar Nagar, Uttar Pradesh, India
|Date of Web Publication||26-Apr-2016|
Department of Anaesthesia, MRA Medical College, Ambedkar Nagar, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Postoperative shivering (PAS) is a common problem following general and spinal anesthesia and may lead to multiple complications. This placebo-controlled, randomized study was performed to evaluate the efficacy of Ondansetron and butorphanol premedication reduces shivering after general and spinal anaesthesia.
Aims: The aim of this study to highlight the efficacy of Butorphenol and ondosteron in controlling postoperative shivering.
Materials and Methods: This clinical trial included 180 patients scheduled for elective general surgery, E.N.T., Ophthamological operations, randomly divided to six groups. Three groups in which General Anaesthesia was used i.e. Group 1-ondansetron 8 mg intravenously(IV).Group 2 butorphanol 2 mg IV and Group 3 – saline 4 ml IV. And three groups where spinal Anaesthesia was used i.e. Group 4-Ondosteron 8 mg IV, Group 5 butorphanol 2 mg IV and Group 6 – saline 4 ml IV 3-5 minutes before anaesthesia. Patients were observed in terms of vital signs, side effects and shivering.
Settings and Design: The type of the study was double blind randomized trial.
Statistical Analysis Used: Statistical Package for Social Sciences version 13.0 statistical analysis software.
Results: Postoperative shivering was observed in 15.5%, 22.2% and 60% in general anaesthesia groups I II and III respectively. The reduction of core and dermal temperature during the anaesthesia and recovery, changes in systolic and diastolic blood pressure and heart rate were similar in all three groups (i.e. Group I ,II,III). In spinal anaesthesia groups, PAS occurred 10%, 13.3% and 43.3% in group IV, V, VI respectively. The reduction of core temperature is similar in all three groups of spinal anaesthesia. But heart rate and mean arterial pressure increase were significant in control saline group in post operative recovery time. No complication seen in any of the six groups.
Conclusion: This study suggested that use of Butorphanol and Ondansteron both are effective in reducing the incidence of PAS after general and spinal anaesthesia.
Keywords: General anesthesia, ondansetron, postoperative shivering, spinal anesthesia
|How to cite this article:|
Rai S, Verma S, Pandey H P, Yadav P, Patel A. Role of butorphanol and ondansetron premedication in reducing postoperative shivering after general and spinal anesthesia: A randomized comparative study from North India. Anesth Essays Res 2016;10:319-23
|How to cite this URL:|
Rai S, Verma S, Pandey H P, Yadav P, Patel A. Role of butorphanol and ondansetron premedication in reducing postoperative shivering after general and spinal anesthesia: A randomized comparative study from North India. Anesth Essays Res [serial online] 2016 [cited 2019 Jun 17];10:319-23. Available from: http://www.aeronline.org/text.asp?2016/10/2/319/172724
| Introduction|| |
Postanesthetic shivering (PAS) is of frequent occurrence and is quite uncomfortable and distressing to the patients. The reported incidence varies from 5% to 65% of patients after general anesthesia and 33% of patients during regional anesthesia.,,,
Apart from the obvious discomfort, PAS, like hypothermia, is associated with a number of potentially deleterious sequelae. These include increased oxygen consumption and carbon dioxide production and catecholamine release, increased cardiac output, tachycardia and hypertension, and raised intraocular pressure. However, patients with the compromised cardiac function may not be able to increase their cardiac output, therefore, may attempt to compensate for the increased oxygen demand by excessive desaturation of the mixed venous blood. PAS also interferes with monitoring. Shivering may endanger the operating results in orthopedic, plastic, and ophthalmic surgery. Hence, prevention and treatment of PAS are an important aspect of patient care.
Though the cause of PAS is not yet clear, some suggestive mechanisms are a pain, adrenal suppression, decreased sympathetic activity, normal thermoregulatory response to intraoperative heat loss, uninhibited spinal reflexes, core hypothermia and redistribution of heat and obliteration of central and peripheral thermoregulatory control.
Shivering can be graded by Tsai and Chu as - Grade 0 = no shivering, Grade 1 = piloerection or vasoconstriction but no visible shivering, Grade 2 = muscular activity in only one muscle group, Grade 3 = muscular activity in more than one muscle group but not generalized shivering, Grade 4 = shivering involving the whole body.
Regional anesthesia produces vasodilatation; which facilitates core to peripheral redistribution of heat. It also increases sweating threshold and decreases vasoconstriction and shivering threshold.
The neurotransmitter pathways involved in the mechanism of PAS are complex and still poorly understood. There is evidence that opioids, alpha-adrenergic, serotonergic, and anticholinergic systems are probably involved. Recently, it has been established that one of the various pathways involved in PAS is through the 5-HT3 receptor, so 5-HT3 antagonist must have a role in prevention PAS.
Some of the drugs well-known for the treatment of PAS are meperidine, butorphanol, nefopam, nalbuphine, tramadol, physostigmine, ketanserin, doxapram, ondansetron, and clonidine.,,
In our study, we compare the effectiveness of butorphanol and ondansetron for reducing the incidence of PAS in anesthesia in a placebo-controlled, double-blind manner. And also to study of changes in body temperature, heart rate, pulse oxygen saturation, and mean arterial pressure (MAP) after administering anesthesia and complications if any.
| Materials and Methods|| |
After the approval of Institutional Ethics Committee of the college and informed consent of the patient, the study was conducted on 180 patients of either sex, ranging from 18 to 60 years, undergoing elective general, otorhinolaryngeal and ophthalmology surgery, Mahamaya Rajkiya Allopathic Medical College, Ambedkar Nagar, Uttar Pradesh from May 2013 to August 2015.
Inclusion criteria were age between 18 and 60 years, with American Society of Anesthesiologists Grades I and II and duration of surgery <2 h. Exclusion criteria were any pyrexial illness, allergy, age <18 years and >60 years, use of vasoconstrictors or vasodilators were planned, anticipating surgery longer than 120 min and hyperthyroidism or cardiopulmonary disease.
A thorough preoperative clinical as well as investigatory assessment was done in all patients. Patients were randomized by using sealed envelope technique to one of the six groups before giving anesthesia:
Group I – Ondansetron 8 mg intravenous (IV) 3–5 min before administering general anesthesia
Group II – Butorphanol 2 mg IV 3–5 min before administering general anesthesia
Group III – Saline IV 3–5 min before administering general anesthesia
Group IV – Ondansetron 8 mg IV 3–5 min before administering spinal anesthesia
Group V – Butorphanol 2 mg IV 3–5 min before administering spinal anesthesia
Group VI – Saline IV 3–5 min before administering spinal anesthesia.
These trial preparations were prepared fresh and by persons blinded to the study. All patients receive 4 ml injection, the volume of ondansetron and butorphanol being made up with normal saline to 4 ml. The injection of trial medication was given immediately after placement of IV cannula and 3–5 min before induction of anesthesia or performing the regional block.
Core temperature was recorded by using temperature probe by placing it in nasopharynx under the aseptic condition, and the peripheral temperature was recorded by temperature probe on the dorsum of the middle finger of the right hand. Baseline heart rate, MAP, and oxygen saturation were also recorded.
Analgesia was provided with injection ketorolac 30 mg intramuscular 1 h before induction and after induction and injection diclofenac (aqua) 75 mg in 100 ml normal saline and run over 30 min to be given intraoperatively.
General anesthesia was induced by propofol 2–2.5 mg/kg and intubation was done with vecuronium 0.1 mg/kg. Anesthesia was maintained within 70% N2O in O2. Spinal anesthesia was given with 15–17.5 mg of hyperbaric bupivacaine at L3–L4 level in lateral position. PAS was defined as readily detectable fasciculation or tremor of the face, trunk, or limb of 15 s duration.
These following parameters were recorded, i.e., the appearance of shivering – (intraoperative and early postoperative period up to 1 h), body temperature recording – (core and peripheral temperature), heart rate, MAP and oxygen saturation, and complication if any. These parameters were recorded every 10 min.
The incidence of shivering was tested statistically by using χ2 test with Yates' correction. Differences in demographic data and the effects of treatment on all studied variables were tested by one-way analysis of variance. Data were presented as mean ± standard deviation. P < 0.05 was considered statistically significant.
| Results|| |
The demographic profile of all six groups each comprises 30 patients are given in [Table 1]. No significant difference was found in terms of age, weight, and height.
[Figure 1] indicates a significant reduction in heart rate compared with baseline after the induction of anesthesia, but values tending to recover to preinduction values once surgery had commenced. However, there were no significant differences among the groups intraoperatively. However, heart rate at recovery and in the postoperative room shows a significant increase in control Groups III and VI as compared to ondansetron group or butorphanol group (P < 0.05).
[Figure 2] shows a significant reduction in MAP compared with baseline after the induction of anesthesia, with MAP values remaining lower than baseline for the duration of administration of anesthesia. However, there were no significant differences among the groups intraoperatively. However, MAP values at recovery and in the postoperative room shows a significant increase in the control group as compared to ondansetron group or butorphanol group (P < 0.05).
[Figure 3] shows mean changes in oxygen saturation in various groups at different intervals. The data above shows no significant differences among the groups intraoperatively. However, oxygen saturation values in the postoperative room show a significant decrease in saline groups III and VI (control) as compared to ondansetron group or butorphanol groups (P < 0.05).
Incidence of shivering (PAS) after general anesthesia occurred in 20.0% (6/30), 23.3% (7/30) in I and II Groups, respectively as compared to 60.0% (18/30) patients of control Group I. which is statistically significant (P = 0.004, control vs. ondansetron that is very significant, P = 0.009, control vs. butorphanol) and (P = 0.754, ondansetron vs. butorphanol that is not significant) [Table 2].
In spinal anesthesia groups, PAS was significantly reduced in patients receiving ondansetron compared with saline control (10% vs. 43.33%, respectively, P = 0.009), and also in patients receiving butorphanol compared with saline control (13.33% vs. 43.33%, respectively, P = 0.022), but there is no significant difference in the incidence of PAS between ondansetron group and butorphanol group (P = 0.68) [Table 2].
No complications were seen in any of the groups at any time in spinal anesthesia during the study.
| Discussion|| |
In this study, the incidence of PAS was significantly reduced in patients receiving ondansetron compared with saline control (20% vs. 60%, respectively, P = 0.004), and also in patients receiving butorphanol compared with saline control (23.3% vs. 60%, respectively, P = 0.009), but there was no significant difference in the incidence of PAS between ondansetron group and butorphanol group (P = 0.75) in general anesthesia as shown in [Figure 1].
A similar study had been done by Powell and Buggy comparing two doses of ondansetron (4 mg and 8 mg) with placebo for prevention of shivering after general anesthesia in which 82 patients (age, 18–60 years) were randomized into three groups in this double-blinded, placebo-controlled, study, PAS occurred in 16 of 28 (57%) patients in Group C, compared with 9 of 27 (33%) in Group O4 (P = 0.13) and 4 of 27 (15%) patients in Group O8 (P = 0.003).
Butorphanol, an easily available opioid, acts through k and μ receptor agonistic modulation though only a few studies have denoted its anti-shivering properties. Vogelsang and Hayes concluded that butorphanol attenuates PAS, so reduces the incidence of shivering. In another study, Vogelsang and Hayes stated that butorphanol relieves PAS more effectively than meperidine.,
Ondansetron and butorphanol also reduce the incidence of PAS after spinal anesthesia. In our study, the incidence of PAS was significantly reduced in patients receiving ondansetron compared with saline (control group) (10% vs. 43.33%, respectively, P = 0.009), and also in patients receiving butorphanol compared with saline (control group) (13.33% vs. 43.33%, respectively, P = 0.022), but there is no significant difference in the incidence of PAS between ondansetron group and butorphanol group (P = 0.68).
Kelsaka et al. 2006, compared ondansetron, meperidine, and placebo for prevention of shivering after spinal anesthesia and in this double-blind study, 75 patients were randomized into three groups and observed that incidence of PAS was 36% in saline (control) group as compared to 8% in the group receiving 8mg ondansetron and 8% in meperidine group.
In another study, butorphanol was compared with tramadol for treatment of shivering after spinal anesthesia by Maheshwari et al. 2008 in which they took 50 patients of 20–40 years of age in two groups, they conclude that tramadol stops shivering in 92% within 2 min while it is 28% with butorphanol in 2 min but within 3–5 min rest 72% were also relieved with butorphanol.
| Conclusion|| |
This study was carried out to compare the efficacy of butorphanol and ondansetron premedication IV along with placebo group to reduce the incidence of PAS.
Both the drugs reduce the incidence of PAS without effecting the core-to-peripheral redistribution of temperature normally observed during general and spinal anesthesia.
Both the drugs show better hemodynamic stability and oxygen saturation in patients. Both the drugs show no significant adverse effects. As compared to ondansetron, butorphanol is a better choice in controlling PAS.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]