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From the Department of Anesthesiology, Tzu-Chi Medical Center, Hualien, Taiwan, R.O.C.
Address correspondence to: Dr. Yi Lee, Department of Anesthesiology, Tzu-Chi Medical Center, No. 707, Sec. 3, Chung-Yang Road, Hualien, Taiwan, R.O.C. E-mail: drleeyi{at}sinamail.com
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Abstract |
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Methods: This randomized, double-blinded, placebo-controlled study was carried out in 168 female patients with (n = 84) and without (n = 84) a history of motion sickness undergoing gynecological laparoscopy. Patients received 8 mg dexamethasone or saline immediately before induction of anesthesia. Postoperatively patients were assessed for 24 hr for nausea, vomiting, and complete response (no vomiting, no need for rescue antiemetics).
Results: The complete response for patients with a history of motion sickness was 80.5% and 37.5% for recipients of dexamethasone and saline, respectively [P < 0.001; number needed-to-treat (NNT) = 2.3]; with corresponding incidences of 83.3% and 53.7% when there was no such history (P = 0.009; NNT = 3.4). Calculation of the efficacy of dexamethasone for the different subgroups shows that dexamethasone was 45.3% more effective in patients with motion sickness than in those without it.
Conclusions: Prophylactic administration of dexamethasone is effective in reducing PONV in patients with and without a history of motion sickness. The results of this study were more favourable in patients with a history of motion sickness, demonstrating a higher effectiveness of dexamethasone for preventing PONV in this subgroup of patients.
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Introduction |
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A clinical trial published in 1993 suggested that dexamethasone can prevent PONV.9 Subsequent studies indicated that dexamethasone may effectively decrease the incidence of PONV in patients recovering from general anesthesia.10–13 Recently, efficacy has also been demonstrated in the prevention of patient-controlled analgesia and epidural-morphine-related nausea and vomiting.14–16 However, the efficacy of dexamethasone as a prophylactic antiemetic for PONV in patients with a history of motion sickness remains unclear. The aim of this study was to evaluate the antiemetic effect of 8 mg iv dexamethasone administered prior to induction of anesthesia, in a sample population of female surgical patients with or without a history of motion sickness.
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Methods |
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Routine monitoring included continuous electrocardiogram, noninvasive blood pressure, capnography and pulse oximetry. Patients with or without motion-sickness history (designated MS+ and MS- groups, respectively) were randomly assigned to one of two treatment regimens: dexamethasone 8 mg (n = 42 each) or saline (n = 42 each). The study medications (2 mL) were prepared by personnel blinded to the study protocols, and were administered intravenously immediately prior to the induction of anesthesia.
The anesthetic regimen was standardized for all patients. Anesthesia was induced with iv glycopyrrolate 0.2 mg, fentanyl 1 µg•kg-1 and thiopental 5 mg•kg-1, with endotracheal intubation facilitated by rocuronium 0.8 mg•kg-1. Anesthesia was maintained using sevoflurane 2–4% and oxygen 50% with air. Ventilation was controlled mechanically and adjusted to maintain the end-tidal CO2 between 4 and 6 kPa throughout surgery. Muscle relaxants were used as required. During surgery, the abdomen was insufflated with carbon dioxide at an intra-abdominal pressure between 1.5 and 2 kPa. All patients received ketorolac iv 30 mg approximately 30 min before the end of surgery, after which the combination of glycopyrrolate and neostigmine (0.6 and 3 mg iv, respectively) were administered for reversal of residual muscle relaxation and the endotracheal tube removed. Esophageal temperature was monitored and maintained at 36–38°C throughout surgery. No additional opioid drugs were administered during the operation.
Postoperatively, the incidence of PONV was collected every six hours for 24 hr. Patients were assessed for the first two hours in the postanesthesia care unit (PACU). The episodes of PONV were identified by direct enquiry or when complaints were made by the patients. Afterwards, patients were asked to record the time of every emetic episode when they were in the ward. If the patient experienced brief instances of nausea and vomiting within an interval of one minute, this was classified as a single emetic episode. Conversely, when the interval between bouts of emesis exceeded one minute, these were deemed separate events.17 In this study, vomiting was defined as the synchronous, rhythmic contraction of the respiratory muscles, even without the expulsion of gastric content. Nausea was scored by using an 11-point visual-analogue scale from 0 to 10, with 0 representing no nausea and 10 representing the worst-possible nausea. More than four episodes of vomiting were considered severe. Average postoperative pain intensity was assessed by the patients themselves using an 11-point scale ranging from 0 to 10 and defining a pain continuum qualitatively defined by the descriptors no pain to unbearable pain, respectively. Analgesia was achieved with ketorolac (15 mg iv). Metoclopramide (10 mg iv) was given as rescue treatment as needed or requested by the patients. The worst score for each symptom during each observation period was recorded. The complete response was defined as no vomiting and no administration of antiemetic rescue medication during the 24-hr observation period.16,18,19 All data were collected by a team of trained nurse anesthetists blinded to the type of treatment received.
The sample size of this study was based on the following power calculation: a) the baseline incidence of PONV in the control group would be 60%;20,21 b) an expected 40% difference in the occurrence of PONV between groups; and b) the type-I error (
) and type-II error (ß) values of 0.05 and 0.2, respectively.22 The estimated sample size was 40 in each group.22 Patient demographic data were analyzed using one-way analysis of variance (ANOVA). The severity of the nausea, vomiting and pain were compared using the Kruskal-Wallis test. The incidence of PONV, antiemetic rescue, and rate of complete response were examined using the 
2 analyses or Fisher’s exact test (two-sided). Data are expressed as mean values with standard deviations, or number and percentage. A P value of less than 0.05 was considered significant. The number needed-to-treat (NNT) and the absolute risk reduction (ARR; = control event rate – (minus) experimental event rate) were also calculated. The NNT is calculated as the inverse of the ARR.19,23 Commercial software SPSS 10.0 (SPSS Inc., Chicago, IL, USA) was used for data processing.
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Results |
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). Of the 168 patients enrolled, four were excluded from the analysis: two required further surgery (laparotomy) during the procedure and two were lost to follow-up.
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. A significantly lower incidence of PONV was demonstrated in MS+ patients receiving dexamethasone than in those receiving saline for the zero to two hours (P = 0.028), zero to six hours (P = 0.008), 6–12 hr (P = 0.035), and 12–18 hr (P = 0.037) observation periods. The lower PONV incidence noted in MS- patients who received dexamethasone was not statistically significant for any observation period. Over the entire 24 hr of observation, dexamethasone significantly reduced the total incidence of PONV by 50.7% in the MS+ group (P = 0.001) and by 32.3% in the MS- group (P = 0.004; Table III). Further, significantly reduced antiemetic requirements (MS+, P < 0.001; MS-, P = 0.009) and a higher rate of complete response (MS+, P < 0.001; MS-, P = 0.009) were also demonstrated for both of the dexamethasone-treated MS+ and MS- subgroups. The calculation of the complete response for the different subgroups shows that dexamethasone was 45.3% more effective in patients with motion sickness than in those without it. When assessed in terms of NNT, effectiveness in the MS+ patients was 2.3 while, in MS- patients, the NNT would be 3.4 patients to achieve the same beneficial effect. In addition, the incidence of PONV in the placebo-treated MS+ subgroup was significantly higher than in the MS- subgroup (P = 0.032). There was no difference between the MS+ and MS- groups treated with dexamethasone (P = 0.804).
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). Further, no delays in wound healing or infection accompanying dexamethasone usage were reported. |
Discussion |
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Most people have suffered from motion sickness at sometime in their lives, however, for many the problem is recurrent and severe.24 Patients with a history of motion sickness have a low threshold for vomiting, and are at increased risk of emetic symptoms.5 Several studies have demonstrated that a previous history of motion sickness is one of the most important predictors of postoperative emesis.6,7 Further, a recent meta-analysis confirmed that the incidence of postoperative vomiting was significantly greater in patients with a history of motion sickness than in those without (58.5 vs 41.7%).8 Fujii et al., also reported a high incidence (70–72%) of PONV for female patients with such a history.7,25 In our study, a remarkably high incidence of PONV (80%) was observed during the first 24-hr after anesthesia for women who had a history of motion sickness, significantly higher in comparison to unaffected individuals (P = 0.032).
The exact mechanism by which dexamethasone exerts its antiemetic action is not fully understood. Kohl et al. have observed that adrenocorticotropin release is more pronounced in response to stressful motion stimuli in individuals who are more resistant to motion. Given the central role of the hypothalamic-pituitary-adrenal axis during the response to stress, this phenomenon has been considered significant in the etiology of motion sickness.26,27 Based on this observation, the efficacy of dexamethasone was tested in subjects exposed to cross-coupled accelerative, semicircular-canal stimulation while seated on a rotating chair. It was determined that subjects given 0.5 mg of dexamethasone every six hours for 48 hr could endure motion that was 80% more stressful.28 These workers indicated that the efficacy of dexamethasone for establishing resistance to motion sickness may be explained in terms of neurochemical action across several neurotransmitter systems which are also modulated by the established antimotion-sickness drugs, scopolamine and amphetamine. As dexamethasone induces adaptive changes within the central nervous system, however, it may prove superior to these drugs, which are short acting, rapidly tolerated, and characterized by significant side-effects.24,28 Hence, it has been suggested that dexamethasone, administered acutely or chronically, may reduce susceptibility to motion sickness.28,29 Furthermore, other studies have shown that glucocorticoid receptors in the nucleus tractus solitarius, the nucleus of raphe, and the area postrema (the chemoreceptor trigger zone) of the brain stem may play important roles in the transmission of impulses to the centre which controls vomiting.5,30,31 Therefore, dexamethasone may exert its antiemetic action through these nuclei.
The dosage of dexamethasone in our study was based on previous work indicating that 8–10 mg has been used most frequently in the prevention of postoperative emesis.10–15 Despite our positive results, further studies should investigate the optimal dose of dexamethasone for the prevention of PONV in patients who are susceptible to motion sickness.
Previous studies have demonstrated that 5-HT3 receptor antagonists (granisetron and ondansetron) are effective for the prevention of PONV when there is a history of motion sickness.7,8,25,32 The relative risk reduction for PONV achieved by dexamethasone prophylaxis in this study is in the range of the relative risk reductions (50–75%) reported with granisetron or ondansetron.7,8 In previous studies, 5-HT3-receptor antagonists have been criticized because of their high cost.33,34 In our hospital, granisetron and ondansetron are approximately 20 and nine times more expensive than dexamethasone at the dosages used, respectively. Therefore, dexamethasone appears to be a cost-effective choice for the prevention of PONV in patients with a history of motion sickness.
In conclusion, the results of our study show that prophylactic antiemetic therapy using iv dexamethasone 8 mg before induction of anesthesia effectively prevents PONV in female patients undergoing gynecological laparoscopy, with or without a history of motion sickness. Dexamethasone 8 mg was more effective in patients with a history of motion sickness than in those without such a history.
Revision received November 29, 2002. Accepted for publication September 16, 2002.
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