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Anesth Analg 2000;91:1256-1261
© 2000 International Anesthesia Research Society

GENERAL ARTICLES

Small-Dose Droperidol Effectively Reduces Nausea in a General Surgical Adult Patient Population

Nevin S. Kreisler, MD, Burkhard F. Spiekermann, MD, Clavio M. Ascari, MD, Heather A. Rhyne, MD, Robin L. Kloth, MD, Lisa M. Sullivan, MD, and Marcel E. Durieux, MD, PhD

Department of Anesthesiology, University of Virginia Health System, Charlottesville, Virginia

Address correspondence and reprint requests to Marcel E. Durieux, MD, PhD, Department of Anesthesiology, Academic Hospital Maastricht, PO Box 5800, G202 A2 Maastricht, The Netherlands. Address e-mail to durieux{at}virginia.edu


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 References
 
In this prospective, randomized, placebo-controlled study, we (1) determined whether 0.625 mg of IV droperidol given 30 min before emergence from general anesthesia reduces the incidence of immediate and delayed postoperative nausea and vomiting (PONV) in a general surgical adult patient population, and (2) compared the efficacy of droperidol, ondansetron, and promethazine for the rescue treatment of PONV. One hundred fifty adult patients receiving general anesthesia for >2 h received either droperidol (0.625 mg IV) or a placebo before emergence. Patients requiring treatment for PONV in the postanesthesia care unit were randomized to receive either droperidol (0.625 mg IV), ondansetron (4 mg IV), or promethazine (12.5 mg IV). Droperidol effectively prevented PONV (6.8% in droperidol-treated patients versus 40.8% in placebo-treated patients, P < 0.001). Droperidol, ondansetron, and promethazine were equally effective in treating established PONV, without significant differences in side effects or time to postanesthesia care unit discharge.

Implications: Droperidol 0.625 mg IV before emergence from general anesthesia effectively reduces postoperative nausea and vomiting (PONV) in the general surgical population. Our randomized, double-blinded, placebo-controlled study demonstrated a reduction in PONV from 41% to 7%. Droperidol is a safe and inexpensive alternative to ondansetron. Droperidol, ondansetron, and promethazine are also equally effective in treating PONV in the postanesthesia care unit.


   Introduction
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 Abstract
 Introduction
Methods
 Results
 Discussion
 References
 
Postoperative nausea and vomiting (PONV) remains a considerable problem for patients after surgery (1). In fact, with the ever-increasing safety of anesthesia, PONV is now one of the greatest concerns that patients express regarding anesthesia and surgery; when surveyed preoperatively, 72% of patients stated that prevention of PONV should be given the highest priority (2). In addition to patient concerns, PONV remains one of the primary reasons for delayed discharge from the postanesthesia care unit (PACU) and for unscheduled admissions after outpatient procedures (1).

PONV is multifactorial, and many risk factors related to the patient, the type of anesthesia, and the type of surgery have been clearly identified as increasing its risk (3). Over the last decade, a multitude of studies has tried to establish the efficacy and cost-effectiveness of various therapeutic modalities for the prophylaxis and treatment of PONV. Most of these were restricted to a specific patient population, specific anesthetic techniques, or specific surgical procedures. Results were quite divergent, and despite the many pharmacologic and nonpharmacologic approaches to the treatment or prevention of PONV, there is no foolproof method. What can be hoped for, at best, is a decrease in the incidence (3).

Droperidol is effective in the treatment and prophylaxis of PONV (4). However, in large doses (2.5 to 5 mg), droperidol has potential side effects that include drowsiness, restlessness, anxiety, and extrapyramidal symptoms. Although a small dose of droperidol (0.625 mg IV) is an effective antiemetic without significant side effects, the usefulness of this compound for PONV prophylaxis has not been studied in a general surgical population, but only in selected subgroups (5–7). In addition, only a few studies have compared small-dose droperidol to other pharmacologic therapies (8–10).

Our study examined three questions: 1) Does routine administration of droperidol 0.625 mg IV to surgical patients undergoing general anesthesia (GA) decrease the overall incidence of PONV in the PACU and within the first 24 h? 2) Are there differences in efficacy between droperidol, ondansetron, and promethazine for the treatment of established PONV with or without droperidol prophylaxis? 3) Are there differences in the side effect profiles or PACU discharge times between patients receiving droperidol prophylaxis and those receiving a placebo?


   Methods
Top
 Abstract
 Introduction
 Methods
Results
 Discussion
 References
 
After obtaining institutional review board approval and written, informed consent, we studied 150 adult patients undergoing GA for a variety of surgical procedures with an expected duration of at least 2 h. In this prospective, randomized, placebo-controlled study, patients were randomized to receive either 0.625 mg of droperidol, IV, or an equal volume of normal saline 30 min before emergence from GA. No restrictions were placed on anesthetic management, but choice of sodium thiopental versus propofol, use of nitrous oxide, amount of opioid used, reversal of neuromuscular blockers, and the administration of steroids were recorded. The only exclusion criteria were age <18 yr, pregnancy, allergy to any of the study drugs, and routine use of antiemetics. The timing of the menstrual cycle was not examined. The only surgical procedures excluded were intracranial and cardiac procedures.

The primary endpoint of the first part of the study was the occurrence of nausea and/or vomiting in the PACU and the secondary endpoint was the occurrence of side effects. On arrival in the PACU, the patient was assessed by a blinded PACU nurse and assigned a nausea and sedation score. The same nurse then reassessed the patient at 15-min intervals up to 225 min or discharge from the PACU, whichever occurred first. Emetic signs and symptoms were graded as: 1 = no nausea, 2 = mild nausea, 3 = severe nausea, and 4 = vomiting/retching. PONV was defined as a score of 2 or greater. Sedation level was graded as: 1 = heavily sedated, 2= moderately drowsy, 3 = mildly drowsy, and 4 = fully awake. Patients were assessed for dizziness, headache, blurred vision, restlessness, dysphoria, and the feeling of a dry mouth. The PACU nurse also recorded any observed extrapyramidal symptoms and the time to PACU discharge. While in the PACU, patients were allowed to receive any postoperative pain medication as ordered by the PACU physician.

If PONV occurred in the PACU, patients were further randomized to receive droperidol, 0.625 mg IV; ondansetron, 4 mg IV; or promethazine, 12.5 mg IV. If further PONV occurred, the PACU physician and nurses were unblinded, and the patient received antiemetic medication as directed by the PACU physician. The need for further rescue medication was the primary endpoint of this part of the study; the secondary endpoint was the occurrence of side effects.

In addition, the incidence of PONV in the first 24 h after discharge from the PACU was determined by patient interview and chart review.

Averaged data were reported as mean ± SD. The results were statistically compared by {chi}2 analysis, or analysis of variance followed by Student’s t-test, corrected for multiple comparisons. Number needed to treat was calculated as the reciprocal of absolute risk reduction. SigmaStat 2.0 (Jandel Corp., San Rafael, CA) was used for data analysis.


   Results
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 Abstract
 Introduction
 Methods
 Results
Discussion
 References
 
One hundred fifty patients were enrolled in the study. As summarized in Table 1, there were no significant differences between the group receiving droperidol prophylaxis and the placebo group with respect to age, gender, history of PONV, case length, nitrous oxide use, amount of narcotic administered, and administration of cholinesterase inhibitors or corticosteroids. Procedure types were not different between the groups (Table 1). The most common procedures were nonintracranial neurosurgery (23%), gynecologic surgery (22%), general surgery (14%), orthopedic surgery (13%), and otorhinolaryngologic surgery (12%). Together, these accounted for 74% of the procedures.


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  		Table 1. Demographics of Study Groups
 
Seventy-four patients received droperidol pretreatment, and 76 patients received the placebo. The proportion of patients in each of the nausea categories (categorized by greatest score during PACU stay) is shown in Figure 1. The proportion of patients free of nausea was significantly greater in the pretreated group (P < 0.001); the proportion of patients who suffered vomiting or retching was significantly greater in the placebo group (P = 0.008). When the average nausea score for each patient over the duration of the PACU stay was calculated, the number of patients who experienced PONV in the PACU was significantly decreased in the droperidol group. After pretreatment with droperidol, 5 of 74 patients (6.8%) experienced PONV, whereas 31 of 76 (40.8%) experienced PONV in the placebo group (P < 0.001). Number needed to treat was 2.9. The proportions of patients in each of the sedation categories (categorized by lowest score during PACU stay) were not significantly different (P > 0.5 for each category), and discharge times from the PACU were similar. Indeed, the trend was for a more rapid discharge when pretreated with droperidol as compared with the placebo (91 ± 39 vs 104 ± 48 min; P = 0.062). There was a trend for droperidol prophylaxis to protect from PONV during the first 24 h postoperatively. Sixteen (22%) patients in the droperidol group versus 24 (32%) patients in the placebo group experienced delayed PONV; however, this was not statistically significant (P = 0.232). There were no significant differences in side effects between the droperidol and placebo groups, although a trend to an increased incidence of dysphoria was noted (Table 2).



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  		Figure 1. Proportions of patients in each nausea category during the postanesthesia care unit stay after placebo or droperidol pretreatment. The greatest score during postanesthesia care unit stay is used for each patient. Nausea was scored as follows: 1 = no nausea, 2 = mild nausea, 3 = severe nausea, and 4 = vomiting/retching.

 

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  		Table 2. Side Effects Observed During 24 h After Administration of Droperidol 0.625 mg IV or placebo
 
All patients who developed PONV received treatment. Because of the small number of patients with PONV occurring in the droperidol pretreatment group, further analysis was performed excluding these five patients. Of the remaining 31 patients, 7 received ondansetron, 14 received promethazine, and 10 received droperidol as rescue medication. Table 3 summarizes the demographic data for these groups. Further PONV, requiring unblinding and administration of a second antiemetic, occurred in 2 of 7 (28.6%) patients who received ondansetron, 3 of 14 (21.4%) patients who received promethazine, and 1 of 10 (10%) patients who received droperidol (Fig. 2). Although the trend was for droperidol to be associated with fewer requests for a second antiemetic, statistical power was insufficient to reach significance (P = 0.613). There was a clear trend for a greater proportion of patients who received droperidol to have low sedation scores (Table 4), but because of the small numbers, this did not reach statistical significance. We found no differences in side effects, length of PACU stay, or PONV at 24 h among the three groups (Table 4).


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  		Table 3. Demographics of Patients Receiving Ondansetron, Promethazine, or Droperidol for Rescue Treatment of PONV
 


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  		Figure 2. Incidence of persistent or recurrent postoperative nausea and vomiting (PONV) after PONV treatment with droperidol, ondansetron, or promethazine. Black = patients with PONV, white = patients without PONV. There were no significant differences among the groups. D = droperidol, O = ondansetron, P = promethazine.

 

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  		Table 4. Side Effects of Ondansetron, Promethazine, and Droperidol When Given as Rescue Medication for PONV
 

   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
References
 
Our study suggests that prophylactic administration of 0.625 mg of IV droperidol given 30 minutes before emergence is very effective in decreasing the incidence of immediate and delayed PONV, with no increase in adverse side effects or delay in PACU discharge. When compared with the placebo, PONV in the PACU decreased from 41% to 7% in patients who received droperidol. In addition, the prophylactic administration of droperidol resulted in a trend toward fewer episodes of PONV throughout the first 24 hours postoperatively (22% vs 32%). Because very few patients or procedures were excluded from the study, our findings underscore the high incidence of PONV in the general surgical patient population. Also, because our study groups were similar, we believe that the difference in the two groups with respect to PONV is directly related to the prophylactic administration of droperidol.

The incidence of PONV in the placebo group is similar to other published results, but the incidence of PONV in the droperidol group is much less than published previously (6,8,9). Fortney et al. (9) found that prophylaxis with droperidol 0.625 mg IV prevented PONV in 63% of adult patients undergoing outpatient surgery. However, the study only included patients considered to be at "high risk" for developing PONV. Similarly, Tang et al. (8) studied the effects of droperidol 0.625 mg IV for outpatient gynecologic procedures (another high-risk patient population), and found the incidence of nausea and vomiting in the PACU to be 34% and 15%, in untreated and treated patients, respectively. Because we assessed the effectiveness of droperidol in the general population encountered at out institution, the greater effect of droperidol in our study may be attributed to the fact that we did not limit our enrollment to high-risk patient groups. Study designs that investigate only restricted patient populations have recently been criticized (11). We believe that our study better represents the reality of clinical practice and, therefore, is a better estimation of the true incidence of PONV with and without prophylaxis.

At doses of 1.25 mg and greater, droperidol has a high incidence of undesirable side effects (12). Using a dose of 0.625 mg, we observed no difference in side effects when comparing droperidol with the placebo. Although the patients who received droperidol had a slightly increased level of sedation, this was not significant, and time to PACU discharge was not delayed. In contrast with a study by Grond et al. (13), the significant decrease in PONV with droperidol prophylaxis did not significantly decrease PACU stay. One possible explanation may be that, at our institution, readiness for PACU discharge is influenced by a multitude of factors in addition to PONV and sedation. Thus, to a great extent, discharge is dictated by the PACU nursing protocol and availability of transportation.

The second part of our study compared the efficacy of droperidol, promethazine, and ondansetron for the rescue treatment of PONV in the PACU. Because of the great effectiveness of droperidol pretreatment, fewer patients developed PONV than we expected. Because only 5 of the 74 patients pretreated with droperidol developed PONV, we did not include these in the analysis of the second study part. Thus, the second of our three study goals could not be addressed adequately. Thirty-one patients in the placebo arm developed PONV and were randomized to receive one of the three study drugs. Because of the small sample size, we were unable to show statistically significant differences in efficacy among droperidol, promethazine, and ondansetron. Power analysis indicates that to show a difference with {alpha} = 0.05 and 1-ß = 0.80, a sample size of approximately 750 patients (of which approximately 300 would become nauseated) is required. Because of the effectiveness of droperidol in this population, we consider it unethical to perform this study on nonpretreated patients. There were no differences in side effects, sedation scores, or time to PACU discharge. Our data suggest that PONV prophylaxis is more effective than the treatment of established PONV. Once PONV is present, a high percentage of patients fail initial rescue therapy and require further antiemetic drugs.

It has been suggested that effective prophylaxis and the resultant decrease in PONV is a "surrogate endpoint" (6). Scuderi et al. (14) found that effective PONV prophylaxis does not improve patient outcome or patient satisfaction and concluded that routine prophylaxis cannot be recommended. Similarly, a meta-analysis by Tramer et al. (15) recommended against the PONV routine prophylaxis with ondansetron, because ondansetron treatment did not improve patient satisfaction although it effectively decreased PONV. However, a difficulty with this approach is that patients cannot experience both arms of the study, and their assessment of satisfaction is, therefore, based on limited information (i.e., would the treated patients be more satisfied if they realized how bad the placebo arm felt?). In addition, patient satisfaction after surgery may be biased by their realization that they just survived surgery and anesthesia. Indeed, a recent study contradicts the findings of Scuderi et al. and Tramer et al., reporting improved patient satisfaction with the routine administration of ondansetron for PONV prophylaxis, and an accompanying editorial challenges the "surrogate endpoint" argument (16,17). Our study did not assess patient satisfaction. Although we may be biased, it is our belief that a significant reduction of PONV implies more for patient care than a mere surrogate outcome.

The meta-analysis by Tramer et al. (15) also concluded that a significant number of patients developed increased levels of aspartate aminotransferase and alanine aminotransferase and complained of a headache after the administration of ondansetron. In addition, a cost-benefit analysis considered the administration of prophylactic ondansetron nonprofitable. We are unaware of any significant biochemical alterations related to the use of droperidol 0.625 mg, and the side effects of droperidol were similar to the side effects in the placebo group. Although we did not perform a cost-benefit analysis, the minimal cost of droperidol (hospital cost of $0.40 per 2.5 mg vial at the University of Virginia) and its small number needed to treat (2.9) for PONV prophylaxis in our study suggests it would be a cost-effective approach in the general surgical population. In fact, a study comparing the cost-effectiveness of ondansetron and droperidol substantiates our assumption (8).

In conclusion, routine administration of droperidol, 0.625 mg IV, is safe and effective in reducing PONV. There is no increased incidence in side effects, and because of its considerable cost advantage over ondansetron, we recommend its prophylactic administration for patients undergoing routine surgery with GA.


   Acknowledgments
 
We thank the nurses from the Preadmission Assessment Center and the Postanesthesia Care Unit of the University of Virginia Health System for donating their time and resources to make this study possible.


   References
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 

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Accepted for publication June 22, 2000.




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Lippincott, Williams & Wilkins 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 HighWire Press