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AMBULATORY ANESTHESIA

A Comparison of the Costs and Efficacy of Ondansetron Versus Dolasetron for Antiemetic Prophylaxis

Eduardo Zarate, MD^*, Mehernoor F. Watcha, MD, Paul F. White, PhD, MD, FANZCA^*, Kevin W. Klein, MD^*, Monica Sa Rego, MD^*, and D. Greg Stewart, MS^*

*Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas; and Department of Anesthesiology and Critical Care Medicine, Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania

Address correspondence to Paul F. White, PhD, MD, FANZCA, Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center at Dallas, 5161 Harry Hines Blvd., CS2.126, Dallas, TX 75235-9068. Address e-mail to pwhite{at}mednet.swmed.edu

	Abstract

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The optimal dose and timing of 5-HT₃ antagonist administration for prophylaxis against postoperative nausea and vomiting (PONV) remains controversial. Although 5-HT₃ antagonists seem to be most effective when administered near the end of surgery, there are no data on the comparative efficacy or costs associated with the 5-HT₃ antagonists dolasetron and ondansetron when administered at the end of the operation. In this double-blinded study, 200 outpatients undergoing otolaryngologic procedures with a standardized general anesthetic received 4 (O4) or 8 mg (O8) of ondansetron or 12.5 (D12.5) or 25 mg (D25) of dolasetron IV within 30 min before the end of surgery. A blinded observer recorded the emetic episodes, maximum nausea score, recovery room resource and drug use, nursing time spent managing PONV, times to achieve discharge criteria from the Phase 1 and 2 recovery units, postdischarge emesis, and patient satisfaction. Total costs were calculated by using the perspective of a free-standing surgicenter. There were no differences in patient demographics, incidence of PONV, need for rescue medications, time spent in the recovery areas, unanticipated hospital admissions, or patient satisfaction among the four treatment groups. The mean total costs (95% confidence intervals) to prevent PONV in one patient were lowest in the D12.5 group: $23.89 (17.18–28.79) vs $37.81 (30.29–45.32), $33.91 (28.92–39.35), and $75.18 (61.13–89.24) for D25, O4, and O8, respectively. Excluding nursing labor costs did not alter this finding: $18.51 (14.18–22.85), $34.77 (28.03–41.49), $31.77 (28.92–39.35), and $71.76 (58.17–85.35) for D12.5, D25, O4, and O8, respectively. We conclude that 12.5 mg of dolasetron IV is more cost effective than 4 mg of ondansetron IV for preventing PONV after otolaryngologic surgery and is associated with similar patient satisfaction.

Implications: When administered at the end of surgery, 12.5 mg of dolasetron IV is as effective as 25 mg of dolasetron IV, 4 mg of ondansetron IV, and 8 mg of ondansetron IV in preventing emetic symptoms after otolaryngologic surgery and was associated with similar patient satisfaction at a reduced cost. There were no differences in the antiemetic efficacy of the 4 and 8 mg doses of ondansetron.

	Introduction

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Postoperative nausea and vomiting (PONV) is a common problem after outpatient surgery. Ondansetron, the prototype serotonin 5-HT₃ antagonist, is safe and effective in the prophylaxis of PONV after high-risk procedures, such as otolaryngological (ENT) surgery (1). Although the manufacturer of ondansetron has recommended that it be administered in a dose of 4 mg IV before the induction of anesthesia (2), controversy surrounds the optimal dose and timing of its administration for antiemetic prophylaxis (1–5). In a meta-analysis, Tramer et al. (5) recommended a larger IV dose of 8 mg ondansetron for prophylaxis against PONV (5).

The introduction of newer 5-HT₃ antagonists, such as dolasetron, has also led to debate regarding the relative cost-effectiveness of these compounds compared with ondansetron in routine clinical practice (6–10). In one study (10), 50 mg of dolasetron IV (but not 25 mg IV) was as effective as 4 mg of ondansetron IV in preventing PONV when administered before the induction of anesthesia. However, in other studies, the minimally effective dose of dolasetron was 12.5 mg IV when administered within 30 min of the end of the surgical procedure (7,9). There are also increasing data suggesting that the frequency and severity of the emetic episodes is decreased when ondansetron is given at the end of surgery compared with its administration at the induction of anesthesia (1,4). Although there are studies comparing the efficacy of prophylactic 4 and 8 mg of ondansetron administered during the induction of anesthesia, there are no similar studies comparing the efficacy of these doses when administered at the end of surgery. Similarly, there are no data available on the comparative efficacy or costs associated with the prophylactic use of dolasetron, a less expensive alternative to ondansetron, when these drugs are administered at the end of surgery.

The primary aim of this study was to compare the relative costs and efficacy associated with the use of dolasetron versus ondansetron for routine prophylaxis against PONV in a high-risk ENT population. A secondary aim was to compare the antiemetic efficacy of different dosages of ondansetron (4 or 8 mg IV) and dolasetron (12.5 or 25 mg IV) when administered at the end of surgery.

	Methods

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After we obtained approval from the local institutional review board and written, informed consent, 200 ASA physical status I and II outpatients (age 20 to 75 yr) undergoing ENT procedures were studied according to a randomized, double-blinded protocol. Patients were excluded if they had received any antiemetic medication within 24 h before their operation, were pregnant, had clinically significant cardiovascular, neurologic, renal, hepatic, gastrointestinal, or endocrinological diseases, had a history of drug abuse, or were >100% above their ideal body weight. Patients were asked to provide a detailed medical history and demographic information, including age, weight, height, and alcohol or drug consumption, as well as any history of PONV or motion sickness.

Before entering the operating room (OR), patients completed baseline visual analog scales (VAS) for sedation, fatigue, comfort, pain, and nausea by using a 100-mm scale, with 0 = none to 100 = maximum. All patients received midazolam 0.02 mg/kg IV for premedication. On arrival in the OR, standard monitoring devices were placed. Anesthesia was induced with propofol 1.5 mg/kg IV and remifentanil 1 µg/kg IV. Tracheal intubation was facilitated with rocuronium 0.6 mg/kg IV, and anesthesia was maintained with sevoflurane 0.75% end-tidal concentration in combination with air (1.0 L/min) and oxygen (1.0 L/min). An infusion of remifentanil was administered at an initial rate of 0.125 µg/kg · min and subsequently varied from 0.0625 to 0.375 µg · kg^-1 · min^-1 to maintain heart rate and blood pressure values within 15% of baseline values.

Patients were randomly assigned to receive one of four IV antiemetic study medications: 1) 12.5 mg of dolasetron; 2) 25 mg of dolasetron; 3) 4 mg of ondansetron; and 4) 8 mg of ondansetron. The study drug was prepared by the OR pharmacist according to a computer-generated random number schedule, diluted to a total volume of 5 mL and administered within a 30-min interval before the end of surgery. At the end of the surgical procedure, residual neuromuscular block was antagonized with 50–80 mg of edrophonium and 0.5–0.8 mg of atropine IV, and all anesthetic drugs were discontinued.

A blinded observer recorded the time from the end of surgery until patients were able to open their eyes, could follow commands (e.g., squeeze the investigator’s hand), and were oriented to their name, place, and date of birth. The times to sitting, standing, tolerating oral fluid, ambulating, the duration of the recovery room stay, and actual discharge were assessed at 15-min intervals. "Home readiness" was determined by using a standardized postanesthetic discharge scoring system (1,4). The VAS scores for sedation, fatigue, comfort, pain, and nausea were repeated at 30 min after the end of anesthesia administration and at the time of discharge. All side effects occurring during the perioperative period (e.g., arrhythmias or marked Q-T prolongation during the administration of study drugs, postoperative nausea, vomiting or retching, headache, and pain), as well as the requirements for any "rescue" medications, the time to achievement of discharge criteria, and the actual time of discharge were recorded. When the patient vomited or requested treatment for persistent nausea, 6.25 mg of promethazine IV was administered. When symptoms persisted, patients were administered 1.25 mg of droperidol IV. Patients who complained of pain in the postanesthesia care unit (PACU) received 25 µg of fentanyl IV bolus doses, until they were comfortable. Pain in the second-stage recovery area and postdischarge pain was managed with oral hydrocodone/acetaminophen.

A trained interviewer who was "blinded" to the group assignment contacted all patients by telephone 24 h after discharge from the hospital to inquire about postdischarge side effects and the need for any therapeutic interventions at home. Patients were also asked to determine the maximum nausea during the previous 24 h by using a 0 (none) to 10 (worst possible) verbal rating scale. In addition, the interviewer read a structured question designed to assess patient satisfaction with the anesthetic experience on a three-point Likert scale. The question asked, "How would you rate your satisfaction with the anesthesia provided—highly satisfied, satisfied, or highly dissatisfied?"

The perspective used in the cost analysis was that of a freestanding surgicenter in a managed care environment. Direct costs for the management of emesis included the costs for "emesis clean-up" (4), rescue antiemetics, management of the side effects of prophylactic and rescue antiemetic drugs, as well as the costs of the drugs, supplies, and labor (Table 1). In this model, all costs were based on the acquisition costs of the study drugs rather than on patient charges, and included the costs of wasted drugs. Costs of materials used for emesis clean-up were limited to those used in the center before discharge. Nursing labor costs were adjusted according to the place of occurrence, with higher costs assigned to the more labor-intensive PACU recovery area.

An a priori power analysis indicated that 49 patients were needed to be enrolled in each group for an 80% chance of detecting a 33% reduction in mean of the total costs for managing PONV from $18 to $12 at the P = 0.05 level of significance. For the power analysis, assumptions of the standard deviations of the costs were taken from previously published data (4,11). This group size would have an 80% power of detecting a 30% difference in the success rates for preventing PONV, assuming the success rates for 4 and 8 mg of ondansetron IV were similar to those reported in the meta-analysis by Tramer et al. (12).

Statistical analysis was performed with Statview Version 5.0 for Windows (SAS Institute, San Francisco, CA). A one-way analysis of variance was used to compare the continuous variables among the treatment groups. If a significant difference was noted, a Newman-Keuls multiple-comparison test was used to determine intergroup differences. Categorical variables were analyzed by using the ² test with Yates’s continuity correction or Fisher’s exact test, as appropriate. A P < 0.05 was considered statistically significant. For the cost analysis, the costs to achieve a complete response in one patient with a regimen were considered significantly different if the 95% confidence intervals (CI) did not overlap. Data are presented as mean ± SD, numbers (n), or percentages (%).

	Results

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There were no significant differences among the four treatment groups with respect to demographic data, including age, weight, sex, type and duration of surgery, incidence of motion sickness, or previous PONV (Table 2). In the female patients, there were no differences in the number of days from the start of their last menstrual cycle. The doses of anesthetic drugs including propofol, opioids, muscle relaxants (and their antagonists), steroids, and volume of perioperative IV fluid, did not differ among the four groups.

	Discussion

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This study has demonstrated that 12.5 mg of dolasetron IV is comparable to 4 and 8 mg of ondansetron IV when given at the end of surgery for preventing PONV after ENT surgery. Prophylaxis with dolasetron achieved similar patient satisfaction at a lower cost from the institutional perspective. Fisher (13) has stated that these end points are of greater clinical importance than the surrogate end point related to the incidence of PONV. Although no differences were seen among the groups with respect to these surrogate and nonsurrogate end points, the overall cost savings favored the use of 12.5 mg of dolasetron IV for routine prophylaxis of outpatients undergoing ENT surgery.

Pharmacy and therapeutic committees have shown increasing concern regarding the costs of antiserotonin drugs, such as prophylactic antiemetics, and have frequently asked for pharmacoeconomic justification before introducing a new 5-HT₃ antagonist drug into clinical practice (14). In this study, the total costs of using 12.5 mg of dolasetron were lower than the other three antiemetic prophylaxis regimens. The total costs were not limited to the acquisition costs of the drug but included nursing labor costs, "emesis cleanup" costs, and resources used in the PACU to manage PONV and the side effects of the drugs (4). These nondrug-related costs are important, because the acquisition cost of a drug is only part of the total costs associated with its use in clinical practice (15). Objections have been raised to including nursing labor costs in the total cost calculation because these costs are semifixed, and the costs to an institution are not increased unless additional nursing staff are hired or overtime payments are made (16,17). However, the costs in the 12.5 mg of dolasetron group remained lower than the other three groups even when the costs of nursing labor and emesis cleanup were excluded, as the costs of prophylactic drugs were the major cost component for managing emesis (Tables 1 and 5).

As expected, the costs of drugs are sensitive to the dose administered. Previous studies have shown that 25 mg of dolasetron is not effective in the prophylaxis of PONV if given at the induction of anesthesia; however, it is effective when administered at the end of surgery (9,10). These studies suggest that the minimally effective dose of dolasetron that should be administered at the end of surgery is 12.5 mg (9). The efficacy of prophylactic 12.5 and 25 mg of dolasetron IV were similar when administered at the end of surgery. The practice of administering antiemetics before the induction of anesthesia was based on the hypothesis that block of specific receptors in the chemoreceptor trigger zone before the arrival of emetic stimuli would be associated with greater antiemetic efficacy. There is both direct and indirect evidence supporting the practice of administering prophylactic antiemetic drugs near the end of the operation. In addition to the previously mentioned studies involving ondansetron and dolasetron, Ferrari and Donlon (18) have reported that 0.15 mg/kg of metoclopramide IV administered immediately after surgery is effective in preventing PONV after tonsillectomy. However, Furst et al. (19) failed to demonstrate any antiemetic activity with metoclopramide despite administering doses as large as 0.5 mg/kg IV immediately after the induction in a similar patient population.

Controversy also surrounds the recommended dose of the 5-HT₃ antagonist ondansetron for antiemetic prophylaxis. In their meta-analysis, Tramer et al. (12) concluded that the minimally effective dose of ondansetron for the prophylaxis of PONV was 8 mg. This conclusion was not based on studies directly comparing the efficacy of 4 and 8 mg doses, but on comparisons of the efficacy of these doses with placebo. Tramer et al. (12) calculated the 95% CI of the numbers-required-to-treat (NNT) with each dose and recommended a dose of 8 mg (because the 95% CI of the NNT with this dose did not overlap the 95% CI of the NNT for 4 mg). However, the meta-analysis included only three studies directly comparing the efficacy of prophylactic ondansetron in doses of 4 or 8 mg IV, and these studies (2,12,20,21) reported no significant differences between the two doses. Our current study similarly failed to demonstrate increased efficacy with 8 mg of ondansetron compared with a 4-mg dose. In addition, the pooled odds ratio, from a total of 686 high-risk patients in the previous studies (2,20,21) and the current study, did not demonstrate significant differences in the efficacy of the two doses. Thus, these findings support the manufacturer’s Food and Drug Administration-approved recommendation that ondansetron should be administered in a dose of 4 mg IV for prophylaxis against PONV.

The current study can be criticized because we chose not to include a placebo control. Given the high incidence of emesis after ENT surgery, we felt it would not be ethical to deny these high-risk patients the benefits of prophylactic antiemetic therapy (22). However, there is still controversy regarding the issue of antiemetic prophylaxis versus treatment (23). Based on a recent study by Scuderi et al. (24), Fisher (25) suggested that routine antiemetic prophylaxis may not be warranted, even in high-risk patient populations. Unfortunately, failure to control for the type of surgery, anesthetic technique, and optimal timing of ondansetron administration may have contributed to the negative findings in the study by Scuderi et al. (24). In large, placebo-controlled studies involving women undergoing gynecologic procedures, both Tang et al. (4) and Fortney et al. (26) found a significant improvement in patient satisfaction when 4 mg of ondansetron IV was administered for prophylaxis compared with a placebo group receiving treatment only after emetic symptoms occurred in the recovery room. A recent article by Sadhasivam et al. (27) confirmed the benefits of a 4-mg dose of ondansetron given at the end of surgery in improving patient satisfaction. Scuderi et al. (24) also reported a higher level of satisfaction with prophylaxis (versus treatment) in a subset of women undergoing highly emetogenic procedures. Therefore, we feel that routine antiemetic prophylaxis is indeed justified in outpatients undergoing high-risk surgical procedures.

Finally, it was not the aim of this study to compare the cost-effectiveness of a strategy of antiemetic prophylaxis to treatment with an antiemetic drug when patients develop PONV symptoms. The overall cost savings when prophylactic antiemetics have been administered to high-risk outpatient populations is sensitive to the risk of emesis without prophylactic antiemetics, the acquisition costs of the drugs used for prophylaxis and treatment, as well as the assigned costs for managing symptoms of PONV (28). In this type of analysis, ondansetron was shown to be cost effective when prophylactically administered to outpatients with a 30% or greater risk for PONV.

In conclusion, 12.5 mg of dolasetron IV is as effective as 25 mg of dolasetron IV, 4 mg of ondansetron IV, and 8 mg of ondansetron IV in preventing PONV after ENT surgery but achieves the same degree of patient satisfaction at a lower cost. Therefore, in situations in which prophylaxis with a 5-HT₃ antagonist is appropriate, 12.5 mg of dolasetron IV administered at the end of surgery appears to be more cost effective than 4 mg of ondansetron IV.

	Acknowledgments

 
We thank the faculty and residents of the Departments of Anesthesiology and Otolaryngology at University of Texas Southwestern Medical Center in Dallas, and Huaquing Zhao of the Department of Biostatistics and Epidemiology, Children’s Hospital of Philadelphia for his assistance in evaluating the cost data.

	References

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Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999