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Biomedical subjects

Christian C Apfel

Publications and source records attributed to Christian C Apfel.

9 recordsLinked to original sources
PubMed2005

Prospective application of a simplified risk score to prevent postoperative nausea and vomiting.

PURPOSE: To compare the risk-adapted approach with ondansetron against ondansetron plus dexamethasone to prevent postoperative nausea and vomiting (PONV) in a randomized clinical trial. METHODS: 460 patients scheduled for elective surgery were enrolled in this prospective study and stratified according to a simplified risk score for PONV. Patients having no or one risk factor were considered at low risk (group L) and did not receive study medication. Those with two to four risk factors were considered high risk and were randomized to receive 4 mg ondansetron plus placebo (group H-O) or 4 mg ondansetron plus 8 mg dexamethasone (group H-OD). Incidence and intensity of PONV were observed for 24 hr after surgery. Data were analyzed with Fisher's exact or Student's t tests; P < 0.05 was considered statistically significant. RESULTS: The incidence of PONV was 9% in group L (n = 87), 31% in those receiving ondansetron (group H-O, n = 185), and 22% in those receiving both drugs (group H-OD, n = 181). The incidence of PONV was significantly smaller in both high-risk groups than predicted without treatment (P < 0.001). While the incidence of PONV failed statistical significance between the two intervention groups (P = 0.08), the mean number of episodes of PONV and the mean maximal intensity of each episode of PONV were lower in group H-OD (P = 0.03 and P = 0.01, respectively). Patients of group H-OD required less antiemetic rescue therapy (P = 0.004). CONCLUSIONS: Ondansetron plus dexamethasone prevents PONV more effectively than ondansetron alone in patients at high risk for PONV.

Adult↗
PubMed2005

PONV: a problem of inhalational anaesthesia?

Even nowadays every third or fourth patient suffers from postoperative nausea and vomiting (PONV) after general anaesthesia with volatile anaesthetics. There is now strong evidence that volatile anaesthetics are emetogenic and that there are no meaningful differences between halothane, enflurane, isoflurane, sevoflurane, and desflurane in this respect. However, when propofol is substituted for volatile anaesthetics the risk for PONV is reduced by only about one fifth, indicating that there are other even more important causes for PONV following general anaesthesia. A main causative factor might be the use of perioperative opioids, but their impact--relative to other factors including volatile anaesthetics--has never been quantified. Patient-specific risk factors have also been shown to be clinically relevant; they are therefore included in the calculation of simplified risk scores that allow prediction of a patient's risk independent of the type of surgery. Although controversial, the well-known different incidences following certain types of surgery are most likely caused by patient-specific and anaesthesia-related risk factors. There is a common consensus that prophylaxis with anti-emetic strategies is rarely justified when the risk of PONV is low, while it is warranted in case of imminent medical risk associated with vomiting or in a patient with a high risk for PONV. A recently published large multicentre trial of factorial design, IMPACT, has demonstrated that various anti-emetic strategies are associated with a very similar and constant relative reduction rate of about 25-30% and that the main predictor for the efficacy of prophylaxis is the patient's risk for PONV. Interestingly, all anti-emetics (dexamethasone, droperidol and ondansetron) work independently, so that their combined benefit can be derived directly from the single effects. The effectiveness of the anti-emetics was also independent of a variety of risk factors, including volatile anaesthetics. This means that any anti-emetic prophylaxis for PONV induced by volatile anaesthetics is equally effective. Of course, the most logical approach for prevention would be the omission of volatile anaesthetics and nitrous oxide using a total intravenous anaesthesia with propofol. However, since volatile anaesthetics are probably not the most important risk factors, it might be even better--if appropriate--to avoid general anaesthesia by using a regional, opioid-free anaesthesia if PONV is a serious problem.

Anesthesia, Inhalation↗
PubMed2004

A factorial trial of six interventions for the prevention of postoperative nausea and vomiting.

BACKGROUND: Untreated, one third of patients who undergo surgery will have postoperative nausea and vomiting. Although many trials have been conducted, the relative benefits of prophylactic antiemetic interventions given alone or in combination remain unknown. METHODS: We enrolled 5199 patients at high risk for postoperative nausea and vomiting in a randomized, controlled trial of factorial design that was powered to evaluate interactions among as many as three antiemetic interventions. Of these patients, 4123 were randomly assigned to 1 of 64 possible combinations of six prophylactic interventions: 4 mg of ondansetron or no ondansetron; 4 mg of dexamethasone or no dexamethasone; 1.25 mg of droperidol or no droperidol; propofol or a volatile anesthetic; nitrogen or nitrous oxide; and remifentanil or fentanyl. The remaining patients were randomly assigned with respect to the first four interventions. The primary outcome was nausea and vomiting within 24 hours after surgery, which was evaluated blindly. RESULTS: Ondansetron, dexamethasone, and droperidol each reduced the risk of postoperative nausea and vomiting by about 26 percent. Propofol reduced the risk by 19 percent, and nitrogen by 12 percent; the risk reduction with both of these agents (i.e., total intravenous anesthesia) was thus similar to that observed with each of the antiemetics. All the interventions acted independently of one another and independently of the patients' baseline risk. Consequently, the relative risks associated with the combined interventions could be estimated by multiplying the relative risks associated with each intervention. Absolute risk reduction, though, was a critical function of patients' baseline risk. CONCLUSIONS: Because antiemetic interventions are similarly effective and act independently, the safest or least expensive should be used first. Prophylaxis is rarely warranted in low-risk patients, moderate-risk patients may benefit from a single intervention, and multiple interventions should be reserved for high-risk patients.

Anesthesia, General↗
PubMed2004

A risk score-dependent antiemetic approach effectively reduces postoperative nausea and vomiting--a continuous quality improvement initiative.

PURPOSE: In a previous survey, patients at risk for postoperative nausea and vomiting (PONV) were best identified by a simplified risk score. Consequently, we investigated whether a risk score-dependent antiemetic strategy could effectively reduce the incidence of PONV in our department. METHODS: Adult in-patients (n = 428) scheduled for throat, thyroid, breast or gynecological surgery under general anesthesia were prospectively classified in three risk groups (L = low, M = medium, H = high) by using a simplified risk score. Patients in the L group did not receive any antiemetic prophylaxis. Patients in the M group received volatile anesthesia with 0.625 mg droperidol or an iv propofol anesthesia without droperidol. Patients in the H group received iv anesthesia supplemented with 4 mg dexamethasone and 0.625 mg droperidol. RESULTS: Compared with the data from our previous survey, the overall incidence of PONV decreased from 49.5% to 14.3% (P < 0.001). The incidence decreased from 34% to 13.2% (P < 0.001) in the M group and from 64.3% to 15.5% (P < 0.001) in the H group. Mean postanesthesia care unit time decreased from 99 to 82 min (P < 0.04). CONCLUSION: This is the first survey which suggests that the departmental incidence of PONV can be significantly lowered by a risk score-dependent antiemetic strategy through a quality improvement initiative.

Adult↗
PubMed2004

A risk adapted approach reduces the overall institutional incidence of postoperative nausea and vomiting.

PURPOSE: Routine prophylactic antiemetic treatment of surgical patients appears justified only in case of an increased risk of postoperative nausea and vomiting (PONV). The objective of this investigation was to assess the feasibility and efficacy of a dichotomized risk score adapted management of PONV based on ondansetron prophylaxis and treatment with respect to the overall institutional rate of PONV. METHODS: After estimating the individual PONV risk by a simplified score, 162 adult patients scheduled for elective surgery received either 4 mg ondansetron intravenously (two to four risk factors = high-risk) or no prophylaxis (zero to one risk factor = low-risk). For antiemetic treatment ondansetron was given intravenously and orally. Incidence of PONV was recorded during the first 24 hr after recovery. RESULTS: Data from 159 subjects were analyzed with 44 patients classified as low-risk and 115 patients classified as high-risk. Nine low-risk and 58 high-risk patients experienced PONV. The expected institutional PONV incidence of 47% was reduced to 36%. Treatment with ondansetron was necessary in seven low-risk and 37 high-risk patients with a complete response rate of 71% (low-risk) and 43% (high-risk). CONCLUSION: Providing antiemetic prophylaxis with ondansetron to high-risk patients strictly based on a simplified risk score can reduce the overall institutional rate of PONV. However, classifying patients into two groups while using ondansetron as the single antiemetic in the high-risk group appears to be of limited efficacy as the incidence of PONV in high-risk patients is still double that of low-risk patients.

Administration, Oral↗
PubMed2003

An international multicenter protocol to assess the single and combined benefits of antiemetic interventions in a controlled clinical trial of a 2x2x2x2x2x2 factorial design (IMPACT).

For various diseases clinicians have to combine different drugs or interventions when a single drug or intervention does not lead to satisfactory results. However, quantifying the relative benefit of certain drugs or interventions when given alone and in combination under controlled conditions requires a complex factorial design. This paper describes such a method applied to a large multicenter trial for the prevention of postoperative nausea and vomiting (PONV), which may be of great interest for other specialties. Approximately 28 million operations are performed annually in the United States, mainly under general anesthesia with volatile anesthetics. Unfortunately, one-third of these patients suffer from PONV. This prompted extensive research of antiemetic and anesthetic drugs, but none of the interventions appeared to satisfactorily prevent PONV. Scuderi et al. were the first to almost eliminate PONV by combining various antiemetic interventions; however, the relative benefit of each intervention remained unclear. Accordingly, we have designed a large randomized controlled trial studying six different antiemetic interventions-three involving use of various antiemetic drugs and three involving choice of anesthetic drugs-to answer the following main questions: (1) What is the relative benefit of each of the antiemetic intervention? (2) Are certain combinations of antiemetic interventions more effective than others? Using a complete factorial design this leads to 2(3)=8 antiemetic combinations, which multiply with the 2(3)=8 combinations of anesthetic drugs, leading to a total of 2(6)=64 possible combinations. The six factors are the antiemetics ondansetron (versus control), dexamethasone (versus control), droperidol (versus control), and the intravenous anesthetic propofol (versus volatile anesthetics), air (versus nitrous oxide), and remifentanil (versus fentanyl). The primary outcome is freedom from PONV within the first 24 hours after anesthesia. Eligible patients are adults scheduled for elective surgery under general anesthesia with an increased risk for PONV so that the expected incidence in the control group (with none of the six antiemetic interventions) is approximately 60%. In order to allow analyses for up to three factor interactions, a sample size was estimated to be in the range of approximately 5000 patients. To the best of our knowledge this is the first randomized controlled trial of a six-way factorial design that may serve as an example for numerous other medical specialties.

Anesthesia, Inhalation↗