Dexamethasone is as effective as ondansetron for the prevention of postoperative nausea and vomiting following breast surgery

INTRODUCTION: Postoperative nausea and vomiting remain a common problem following breast surgery. This study assesses whether dexamethasone is as effective as ondansetron in the control of postoperative nausea and vomiting (PONV). METHODS: Eighty ASA I-III patients undergoing breast surgery for carcinoma of the breast were included in the study. Following premedication with diazepam 5-10 mg, patients were induced with fentanyl 50 micro g and propofol 2-2.5 mg kg-1. A larynx mask was inserted and anesthesia maintained with sevoflurane in oxygen and nitrous oxide. Patients were then randomly divided into two groups: Group D (dexamethasone) was given 4 mg dexamethasone i.v. after induction and Group O (ondansetron) was given 4 mg ondansetron at the same time point. Postoperatively, nausea, vomiting and pain were recorded at 1-h intervals during 4 h, and thereafter every 4 h during 24 h. RESULTS: The incidence of PONV during 24 h was 37% and 33% in Group D and Group O, respectively (NS). No differences were found between the groups in the incidence of postoperative nausea, vomiting or pain at the different time intervals. No differences were found in the incidence of PONV in smokers vs. non-smokers. No side-effects of these drugs were observed. CONCLUSIONS: Ondansetron 4 mg or dexamethasone 4 mg are equally effective in the prevention of postoperative nausea and vomiting following breast surgery. Other factors being similar, the difference in cost between these drugs would favor the use of dexamethasone instead of ondansetron when monotherapy against PONV is used.     

枢复宁预防全麻腹部手术后恶心和呕吐的临床研究

全麻患者术后常易发生恶心、呕吐，枢复宁有抗呕吐作用。随机选择１００例腹部外科手术患者，分为枢复宁组（４ｍｇ，ｎ＝５０）和安慰剂组（生理盐水，ｎ＝５０），诱导前静注枢复宁或安慰剂，注速１分钟，双盲法观察术后２４小时抗恶心、呕吐效果及副作用。结果表明，用药组恶心、呕吐发生率（１８％，０）明显低于安慰剂组（５０％，４０％）（Ｐ＜０．０１），两组患者的平均动脉压、经皮血氧饱和度，呼吸频率和心率，血液成分，肝、肾功能无明显改变。因此，枢复宁适用于腹部外科患者术后恶心、呕吐的防治。     

术后恶心呕吐的风险评估及防治方法

术后恶心呕吐是最常见的术后并发症之一,防治其发生有重要的临床意义。现就近几年来关于术后恶心呕吐的风险因素、评估方法以及防治方面的研究进展作一综述。     

Cost-effectiveness of ondansetron for postoperative nausea and vomiting

The decision as to whether prophylaxis against postoperative nausea and vomiting is better than treatment of established postoperative nausea and vomiting could be made on the basis of cost-effectiveness. The cost-effectiveness of ondansetron was calculated using data from published quantitative systematic reviews of randomised trials. Milligrams of ondansetron required to achieve a desired endpoint were chosen as a cost unit. Modelling was based on a cohort of 1000 patients, and examined control event rates (i.e. incidence of postoperative nausea and vomiting without prophylaxis) of between 10 and 90%. In a sensitivity analysis, cost-effectiveness of recommended intravenous doses (4 mg for treatment and prophylaxis) was compared with minimal effective doses as shown by meta-analysis (1 mg for treatment, 8 mg for prophylaxis). Fewer patients experience any postoperative nausea and vomiting symptoms with prophylaxis compared with treatment. But prophylaxis is only marginally more effective than treatment, and treatment of established postoperative nausea and vomiting with effective doses (i.e. 1 or 4 mg) is more cost-effective and safer than prophylaxis with effective doses (i.e. 4 or 8 mg). Reasons for this are the selective treatment of patients who actually need treatment, the high success rate with a lowest dose tested (1 mg) in established postoperative nausea and vomiting, and the disappointing antinausea effect of prophylactic ondansetron even at an eight-fold higher dose.     

Simplified algorithm for the prevention of postoperative nausea and vomiting: a before-and-after study

Background

Poor adherence to guidelines aimed at reducing the incidence of postoperative nausea and vomiting (PONV) is well known. In a before-and-after study, we tested the effectiveness of a simplified algorithm for PONV prophylaxis on the incidence of PONV.

Comparison of ondansetron and droperidol in the prevention of postoperative nausea and vomiting after laparoscopic surgery in women

Background : Women undergoing laparoscopic surgery are susceptible to postoperative nausea and vomiting (PONV). Ondansetron and droperidol are useful antiemetics. This study was designed to ascertain primarily the relative difference in efficacy of ondansetron and droperidol and secondarily between these drugs and placebo in the prevention of PONV after laparoscopic surgery. Methods : The prophylactic antiemetic efficacy of ondansetron and droperidol was compared in a prospective, randomised, double–blind, placebo–controlled trial of 439 female inpatients scheduled for laparoscopic surgery. During induction of standardised general anaesthesia the patients received intravenously either ondansetron 8 mg (n=195), droperidol 1.25 mg (n=193) or placebo (n=51). The occurrence of nausea, vomiting, sideeffects and the need for rescue antiemetic medication were recorded for 24 h postoperatively. Results : The proportion of patients with nausea was 48%, 50% and 67% in the ondansetron, droperidol and placebo groups, respectively; with a significant difference when both ondansetron (P=0.02) and droperidol (P=0.04) were compared with placebo. Vomiting occurred in 18%, 26% and 37% of the patients in the three groups, respectively (P=0.05 between ondansetron and droperidol, P=0.004 between ondansetron and placebo, P=0.16 between droperidol and placebo). The proportion of patients given rescue medication was 34%, 28% and 49%, respectively (P=0.23 for ondansetron and droperidol, P=0.07 for ondansetron and placebo, P=0.007 for droperidol and placebo). During early recovery the patients treated with ondansetron were significantly more alert than after droperidol. Serious side–effects were not observed. Headache was significantly more common after ondansetron than after droperidol treatment. Conclusions : The efficacy of prophylactic ondansetron and droperidol in reducing postoperative nausea associated with laparoscopic surgery in female inpatients was similar, but ondansetron appeared to be slightly more efficient than droperidol in preventing vomiting. Ondansetron and droperidol were both significantly better than placebo in the prophylaxis of PONV.     

Patient-controlled analgesia and postoperative nausea and vomiting: efficacy of a continuous infusion of ondansetron

A continuous infusion of ondansetron was compared with a placebo infusion in 80 patients undergoing major breast reconstructive surgery. All patients received a standard anaesthetic and a bolus dose of ondansetron after induction. They were then randomly allocated to receive an intravenous infusion of ondansetron or a placebo infusion for 24 h in a double-blind fashion. Postoperative analgesia was provided by patient-controlled subcutaneous diamorphine. In the ondansetron group, the severity of nausea, measured by a 10-point verbal rating scale, was reduced (p = 0.01) and fewer patients stated at postoperative interview that nausea and vomiting was a problem (p = 0.01).     

Comparison of cyclizine and ondansetron for the prevention of postoperative nausea and vomiting in laparoscopic day-case gynaecological surgery

Seventy-four patients undergoing laparoscopic gynaecological surgery were randomly allocated to two groups receiving cyclizine 50 mg or ondansetron 4 mg at induction of anaesthesia. Anaesthetic and postoperative analgesia regimens were standardised. Approximately half of the patients in each group experienced some degree of postoperative nausea and vomiting (cyclizine, 56%; ondansetron, 54%). There was no difference between groups in respect of pre- and postdischarge incidence. Mean (SD) time to eye opening was significantly prolonged in the cyclizine group [10 (4) min vs. 8 (2) min; p < 0.001], but this had no influence on discharge times. Cyclizine and ondansetron appear equally effective in preventing postoperative nausea and vomiting but the 10-fold price differential favours cyclizine.     

A double-blind, parallel-group, placebo-controlled, dose-ranging, multicenter study of intravenous granisetron in the treatment of postoperative nausea and vomiting in patients undergoing surgery with general anesthesia

Study Objective: To compare the effectiveness of granisetron with placebo in the treatment of established postoperative nausea and vomiting (PONV).

Design: Randomized, placebo-controlled study.

Setting: 34 hospitals in Europe, Scandinavia, and South Africa.

Patients: 519 ASA physical status I, II, and III patients who developed PONV within 4 hours of the end of surgery performed with general anesthesia.

Interventions: Patients received a single intravenous dose of granisetron 0.1 mg, 1 mg, or 3 mg, or placebo when symptoms of nausea or vomiting were experienced. Additional rescue medication could be given at the investigator's discretion if nausea and vomiting were not controlled.

Measurements and Main Results: At all doses investigated, granisetron was significantly more effective (p ≤ 0.001) than placebo in controlling vomiting: 38%, 46%, and 49% of patients receiving granisetron, 0.1 mg, 1.0 mg, and 3.0 mg, respectively, experienced no vomiting in the first 24 hours following drug administration, compared with 20% receiving placebo. There was a statistically significant linear relationship between vomiting control and granisetron dose (p < 0.001). Survival distributions of time to resolution of vomiting confirmed the statistically significant difference between patients receiving granisetron and those receiving placebo. Granisetron was well tolerated: the most common adverse experiences were pain, constipation, anemia, and headache, and the incidence of adverse experiences was not statistically significantly higher in any of the granisetron groups than in the placebo group.

Conclusion: Granisetron was significantly more effective than placebo in all groups. Further studies in specific subgroups may be warranted.     

Impact of an antiemetic protocol on postoperative nausea and vomiting in children

The objective of the study was to demonstrate a decreased incidence of postoperative nausea and vomiting (PONV) in children through the use of an antiemetic protocol. PONV was recorded in children (1.5-15 years) after inpatient surgery under general anaesthesia in a prospective, interview based survey. Group 1 consisted of children having surgery 1 month before the introduction of a formalized antiemetic protocol and group 2, 2 months after its introduction. Data were collected over a 1-month period in each group. Outcome measures of nausea, emesis, antiemetic requirement and patient satisfaction were monitored for the first 24-h postoperative period. There were 272 children enrolled: 138 in group 1 and 134 in group 2. There was a difference between the two groups for gender (P=0.03), type of surgery (P=0.017), perioperative opioid (P=0.003) and perioperative antiemetic use (P=0.024). However, multivariate analysis did not demonstrate an impact on outcome from these factors. The incidence of postoperative nausea (PON) and postoperative vomiting (POV) following the introduction of the protocol was 36% and 34%, respectively. Moderate to severe nausea was decreased after introduction of the protocol (18% versus 9%, P=0.028) but moderate to severe vomiting failed to reach significance (19% versus 11%, P=0.078). The proportion of children who had repeated nausea decreased after the introduction of the protocol (17% versus 8%, P=0.02) but repeated episodes of vomiting remained unchanged (19% versus 14%). This was attributed to a significant increase in antiemetic prescribing by protocol in group 2 (10% versus 59%, P < 0.001). Patient satisfaction was high in both groups (85% versus 90%). The introduction of a postoperative antiemetic protocol improved prescribing frequency. This resulted in a decreased incidence of moderate to severe PON and a reduction in the number of patients with repeated nausea.     

Dolasetron for the prevention of postoperative vomiting in children undergoing strabismus surgery

BACKGROUND: Children undergoing strabismus surgery have a high incidence of postoperative vomiting (POV). The purpose of this study was to assess the efficacy and safety of dolasetron for the prevention of emesis comparing a single 0.35 mg.kg-1 or 12.5 mg dose with placebo. METHODS: Children aged 2-12 years with an ASA status of 1 or 2 undergoing strabismus surgery were randomized in a double-blind manner to one of three treatment groups. Patients were excluded with a history of previous postoperative vomiting or motion sickness, allergy to serotonin receptor antagonists or previous antiemetic administration within 24 h prior to enrollment. General anaesthesia was induced with sevoflurane and N2O/O2 and maintained with isoflurane and N2O/O2. The study medication was administered 15 min prior to the end of surgery. Patients experiencing two or more episodes of vomiting were rescued in the postanaesthesia care unit (PACU) with metoclopramide 0.15 mg.kg-1. A total of 118 patients were enrolled with documentation of the number and severity of vomiting episodes, time to awakening, PACU length of stay and postoperative agitation. RESULTS: Patients with an acute complete response (ACR), defined as no emetic episodes and no rescue medication within 24 h of study drug administration were 62% (weight dose), 64% (fixed dose) and 33% (placebo, P < 0.05). CONCLUSIONS: There was no statistical difference between the 0.35 mg.kg-1 dose and the fixed 12.5 mg dose of dolasetron with both reducing the incidence of POV.     

A comparison of cyclizine,ondansetron and placebo as prophylaxis against postoperative nausea and vomiting in children

Nausea and vomiting is a relevant and common problem with unfavourable sequelae in children undergoing some plastic surgery procedures. There is a lack of anti-emetic trials performed in children, with only a few investigating the roles of the older anti-emetic agents such as cyclizine compared with newer ones such as ondansetron. This randomised, controlled, double-blind study examined the effectiveness of a single dose of ondansetron (0.1 mg x kg-1), cyclizine (20 mg) and placebo (normal saline) in the prevention of postoperative nausea and vomiting in 150 children (mean age 3.6 years) undergoing plastic genitourinary procedures. Rates of previous postoperative nausea and vomiting and motion sickness were comparable across the groups. Postoperative vomiting was significantly reduced with ondansetron prophylaxis (p = 0.006) but there was no detectable anti-emetic effect with cyclizine. Furthermore, cyclizine caused pain on injection (p < 0.001).     

How to study postoperative nausea and vomiting

Anesthesiological journals are flooded by innumerable studies of postoperative nausea and vomiting (PONV). Nevertheless, PONV remains a continuing problem with an average incidence of 20-30%. This paper should provide essential information for the design, conduct, and presentation of these studies. It should also increase comparability among future studies and help clinicians in assessing and reading the literature on PONV. First, future studies should address new and relevant questions instead of repeatedly investigating prophylactically given antiemetics whose main results are predictable (e.g. already proven by meta-analysis). Second, group comparability should be based on well-proven risk factors and a simplified risk score for predicting PONV. Endless listings of doubtful risk factors should be avoided. Third, a realistic sample size estimation should be performed, i.e. in most cases at least 100 patients per group are necessary. Fourth, nausea, vomiting and rescue medication should be recorded and reported separately with the corresponding incidences (and number of patients with these separate symptoms), and the main end-point should be PONV. The entire observation period should cover 24 h. Additional reporting of the early (0-2 h) and delayed (2-24 h) postoperative period is desirable and should consider single and cumulative incidences. Lastly, interpretation of results should take into account the study hypothesis, sources of potential bias or imprecision, and the difficulties associated with multiplicity of analysis and outcomes.     

Prophylactic ondansetron for postoperative emesis.Meta-analysis of its effectiveness in patients with previous history of postoperative nausea and vomiting

BACKGROUND: The objective of this study was to compare, by means of meta-analysis, the postoperative antiemetic efficacy of ondansetron in patients with and without antecedents of postoperative nausea and vomiting. METHODS: MEDLINE and EMBASE databases were searched for randomised placebo-controlled trials which evaluated the antiemetic effectiveness of 4 mg and 8 mg intravenous doses of prophylactic ondansetron in adult patients. A further selection was with respect to those studies which noted the patient's previous history of postoperative nausea and vomiting (PH-PONV) and, for the meta-analysis, the patients were divided into two sub-groups: those with (PH-PONV +) and those without a previous history of postoperative nausea and vomiting (PH-PONV -). Absence of vomiting was used as the index of effectiveness. RESULTS: Twenty-one trials involving 3984 patients (2446 in ondansetron groups and 1538 in placebo groups; 1163 PH-PONV(+) patients and 2821 PH-PONV(-) patients) met the selection criteria. The effectiveness of the 4 mg dose of ondansetron was: OR (95% CI)=2.40 (1.77-3.26) vs. 2.71 (2.23-3.30) for the patients of PH-PONV(+) and PH-PONV(-) sub-groups, respectively. For the 8 mg dose, the effectiveness of ondansetron was: PH-PONV(+)=4.21 (2.66-6.66) and PH-PONV(-)=2.61 (1.81-3.59). For neither of the doses evaluated was there any significant statistical difference between the sub-groups. CONCLUSIONS: The effectiveness of ondansetron in the prevention of postoperative vomiting is not affected by the patients' PH-PONV.