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C C Apfel

Publications and source records attributed to C C Apfel.

At least 19 recordsLinked to original sources
PubMed2005

[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: In a randomized, controlled trial of factorial design, 5,199 patients at high risk for postoperative nausea and vomiting were randomly assigned to 1 of 64 possible combinations of 6 prophylactic interventions: 1) 4 mg of ondansetron or no ondansetron; 2) 4 mg of dexamethasone or no dexamethasone; 3) 1.25 mg of droperidol or no droperidol; 4) propofol or a volatile anesthetic; 5) nitrogen or nitrous oxide; 6) remifentanil or fentanyl. The primary aim parameter was nausea and vomiting within 24 h after surgery, which was evaluated blindly. RESULTS: Ondansetron, dexamethasone, and droperidol each reduced the risk of postoperative nausea and vomiting by about 26%, propofol reduced the risk by 19%, and nitrogen by 12%. The risk reduction with both of these agents (i.e., total intravenous anesthesia) was thus similar to that observed with each of the antiemetics alone. All the interventions acted independently of each other 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. However, absolute risk reduction 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.

Analgesics, Opioid↗
PubMed2005

Factorial design provides evidence to guide practice of anaesthesia.

Many scientific articles are written merely to get something published, neglecting the clinician who would like the medical literature to guide their practice. Evidence-based medicine is expected to help in clinical decision-making. Systematic reviews of the literature followed by a meta-analysis of randomized, controlled trials (RCT) have claimed to represent the highest strength of evidence. However, the results published in meta-analyses have not always been confirmed in subsequent large RCTs. An analysis of 12 large RCTs and 19 meta-analyses addressing the same questions found that the outcomes of these large RCTs were not predicted accurately 35% of the time by previously published meta-analyses. Therefore, meta-analyses of several small RCTs do not obviate the need for large, multicentre RCTs, which can still be considered as a gold standard for the development of clinical guidelines or practice plans. Moreover, large RCTs using a factorial design can be highly efficient because they can answer several clinical questions at the same time and offer the only systematic approach to investigate an interaction of combinations in multimodal approaches.

Anesthesia↗
PubMed2004

[Postoperative nausea and vomiting].

Numerous pathophysiological mechanisms are known to cause nausea or vomiting but their role for postoperative nausea and vomiting (PONV) is not quite clear. Volatile anesthetics, nitrous oxide and opioids appear to be the most important causes for PONV. Female gender, non-smoking and a history of motion sickness and PONV are the most important patient specific risk factors. With these risk factors an objective risks assessment is achievable as a good rational basis for a risk dependent antiemetic approach: When the risk is low, moderate, or high, the use of none, a single or a combination of prophylactic antiemetic interventions seems to be justified. Performing a total intravenous anesthesia (Ti.v.A) with propofol is a reasonable prophylactic approach, but does not solve the problem satisfactorily alone if the risk is very high, reducing the risk of PONV only by 30%. This is comparable to the reduction rate of antiemetics, such as serotonin antagonist, dexamethasone and droperidol. It must be stressed that metoclopramide is ineffective. Data from IMPACT indicate that prophylaxis is not very effective if the patients risk is low. At a moderate risk the use of Ti.v.A or an antiemetic is reasonable and only a (very) high risk justifies the combination of several prophylactic antiemetic interventions. For the treatment of PONV an antiemetic should be chosen which has not been used prophylactically. The necessary doses are usually a quarter of those needed for prophylaxis.

Animals↗
PubMed2004

Comparison of surgical site and patient's history with a simplified risk score for the prediction of postoperative nausea and vomiting.

Although site of surgery and previous occurrence of postoperative nausea and vomiting are often used to decide whether prophylactic anti-emetic drugs are indicated, the value of these predictors is unclear. We compared these two risk factors against a simplified four-factor risk score. We analysed data from 1566 adult inpatients who received balanced anaesthesia without prophylactic anti-emetics. Sensitivity, specificity, predictive value and area under the receiver operating characteristic curve were used to quantify predictive properties. Nausea and vomiting occurred in 600 (38.3%) patients within 24 h. Sensitivity and specificity were, respectively, 47% and 59% for surgical site; 47% and 70% for history of postoperative nausea and vomiting; and 58% and 70% for risk score with three or more factors. The area under the curve for surgical site was 0.53 (95% CI 0.50-0.56); that for patient's history was 0.58 (95% CI 0.56-0.61) while for risk score it was 0.68 (95% CI 0.66-0.71; P < 0.001). Prediction using surgical site or patient's history alone was poor while the simplified risk score provided clinically useful sensitivity and specificity.

Adult↗
PubMed2003

[Blocking nociceptive afferents by retrobulbar bupivacaine does not decrease nausea and vomiting after propofol-remifentanil anaesthesia].

UNLABELLED: To test whether prophylactic neural blockade of noziceptive afferents or antiemetics diminutes postoperative nausea and vomiting (PONV) we studied in a randomised, prospective, and ouble-blind fashion 102 patients receiving implantation of an episcleral radioactive applicator for treatment of ocular malignant melanoma during remifentanil-propofol-anaesthesia. METHODS: 15 minutes prior to induction Dolasetron 12.5 mg (n = 18) or 50 mg (n = 20), Ondansetron 8 mg (n = 18), Droperidol 20 microg/kg (n = 23) or NaCl 0.9 % (n = 22) were randomly injected i.v. Furthermore, 4-8 ml Mepivacain 2 %/Bupivacain 0.5 % (n = 52) or saline (n = 50) were injected into the retrobulbar space after anaesthetic induction. Piritramid (0.1 mg/kg) was given for postoperative analgesia 30 minutes before end of surgery. Metamizol (1 g i.v.) and Dolasetron (12.5 mg i.v.) were provided on request as "rescue" medications. Variables were assessed by standardised questioning (NRS; yes/no) before and 1, 6, and 24 hours after surgery. STATISTICS: Chi(2)-, Mann-Whitney-U-, Kruskal-Wallis-test and logistic regression analysis, p < 0.05. RESULTS: Although retrobulbar anaesthesia decreased ocular pain (p = 0.013) and total postoperative complaints (p = 0.017) the incidence of PONV was not diminished. Droperidol was the only antiemetic to decrease PONV significantly (p = 0.001). CONCLUSIONS: Although prophylactic blockade of nozizeptive afferents by retrobulbar anesthesia decreased ocular pain and postoperative complaints, it failed to decrease the incidence of PONV. Thus, PONV after ocular surgery under propofol-remifentanil anaesthesia is not attenuated by preoperative blockade of noziceptive afferents. In patients undergoing total intravenous anaesthesia with propofol-remifentanil, droperidol prevented PONV more effectively than the used serotonin receptor antagonists.

Aged↗
PubMed2002

[Tropisetron for prevention of postoperative nausea and vomiting: a quantitative systematic review].

OBJECTIVE: A quantitative systematic review of randomised controlled trials investigating the efficacy of tropisetron versus placebo to prevent postoperative nausea (PN) and vomiting (PV) as well as PN and/or PV (PONV). METHODS: The relevant results for the 24 h postoperative period were extracted from systematically searched studies (MEDLINE, EMBASE, Cochrane-Library, reference lists; last update December 2001). RESULTS: In 19 studies and 22 comparisons, 1,012 patients received a placebo and 1,267 patients tropisetron and the pooled analyses (2-5 mg iv) are presented. The relative risks (RR) for PN, PV and PONV with tropisetron prophylaxis were 0.72 (95%-CI: 0.62-0.83), 0.59 (95%-CI: 0.47-0.73) and 0.70 (95%-CI: 0.62-0.79), respectively. The RR for rescue treatment was 0.63 (95%-CI: 0.54-0.74). The RR in children for a variable dose of 0.1-0.2 mgxkg(-1) was 0.49 (95%-CI: 0.38-0.63), 0.49 (95%-CI: 0.38-0.63) and 0.32 (95%-CI: 0.15-0.70) for PV, PONV and rescue treatment, respectively. Restricting the analysis to a predefined control event rate of 40-80% revealed that about 6-7 patients need to be treated with tropisetron for PN to be prevented in 1 patient who would have had PN if all had received a placebo (NNT=6.7; 95%-CI: 4.8-11.1). The corresponding NNT for preventing PV and PONV was 5.0 (95%-CI: 3.6-8.3) and 4.6 (95%-CI: 3.6-6.3), respectively. CONCLUSION: Tropisetron significantly reduced the incidence of PONV. There is no clear evidence for a dose response between 2 and 5 mg iv. For children a dose of 0.1 mgxkg(-1) of body weight is effective. Sufficient data for the oral application of tropisetron are lacking.

Administration, Oral↗
PubMed2002

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.

Clinical Trials as Topic↗
PubMed2002

Comparison of predictive models for postoperative nausea and vomiting.

BACKGROUND: In order to identify patients who would benefit from prophylactic amtiemetics, six predictive models have been described for the risk assessment of postoperative nausea and vomiting (PONV). This study compared the validity and practicability of these models in patients undergoing general anaesthesia. METHODS: Data were analysed from 1566 patients who underwent balanced anaesthesia without prophylactic antiemetic treatment for various types of surgery. A systematic literature search identified six predictive models for PONV. These models were compared with respect to validity (discriminating power and calibration characteristics) and practicability. Discriminating power was measured by the area under the receiver operating characteristic curve (AUC) and calibration was assessed by weighted linear regression analysis between predicted and actual incidences of PONV. Practicability was assessed according to the number of factors to be considered for the model (the fewer factors the better), and whether the score could be used in combination with a previously applied cost-effective concept. RESULTS: The incidence of PONV was 600/1566 (38.1%). The discriminating power (AUC) obtained by the models (named according to the first author) using the risk classes from the recommended prophylactic concept were as follows: Apfel, 0.68; Koivuranta, 0.66; Sinclair, 0.66; Palazzo, 0.63; Gan, 0.61; Scholz, 0.61. For four models, the following calibration curves (expressed as the slope and the offset) were plotted: Apfel, y=0.82x+0.01, r2=0.995; Koivuranta, y=1.13x-0.10, r2=0.999; Sinclair, y=0.49x+0.29, r2=0.789; Palazzo, y=0.30x+0.30, r2=0.763. The numbers of parameters to be considered were as follows: Apfel, 4; Koivuranta, 5; Palazzo, 5; Scholz, 9; Sinclair, 12; Gan, 14. CONCLUSION: The simplified risk scores provided better discrimination and calibration properties compared with the more complex risk scores. Therefore, simplified risk scores can be recommended for antiemetic strategies in clinical practice as well as for group comparisons in randomized controlled antiemetic trials.

Adult↗
PubMed2002

Volatile anaesthetics may be the main cause of early but not delayed postoperative vomiting: a randomized controlled trial of factorial design.

BACKGROUND: Despite intensive research, the main causes of postoperative nausea and vomiting (PONV) remain unclear. We sought to quantify the relative importance of operative, anaesthetic and patient-specific risk factors to the development of PONV. METHODS: We conducted a randomized controlled trial of 1180 children and adults at high risk for PONV scheduled for elective surgery. Using a five-way factorial design, we randomly assigned subjects by gender who were undergoing specific operative procedures, to receive various combinations of anaesthetics, opioids, and prophylactic antiemetics. RESULTS: Of the 1180 patients, 355 (30.1% 95% CI (27.5-32.7%)) had at least one episode of postoperative vomiting (PV) within 24 h post-anaesthesia. In the early postoperative period (0-2 h), the leading risk factor for vomiting was the use of volatile anaesthetics, with similar odds ratios (OR (95% CI)) being found for isoflurane (19.8 (7.7-51.2)), enflurane (16.1 (6.2-41.8)) and sevoflurane (14.5 (5.6-37.4)). A dose-response relationship was present for the use of volatile anaesthetics. In contrast, no dose response existed for propofol anaesthesia. In the delayed postoperative period (2-24 h), the main predictors were being a child (5.7 (3.0-10.9)), PONV in the early period (3.4 (2.4-4.7)) and the use of postoperative opioids (2.5 (1.7-3.7)). The influence of the antiemetics was considerably smaller and did not interact with anaesthetic or surgical variables. CONCLUSION: Volatile anaesthetics were the leading cause of early postoperative vomiting. The pro-emetic effect was larger than other risk factors. In patients at high risk for PONV, it would therefore make better sense to avoid inhalational anaesthesia rather than simply to add an antiemetic, which may still be needed to prevent or treat delayed vomiting.

Adolescent↗
PubMed2001

The influence of a dominating centre on a quantitative systematic review of granisetron for preventing postoperative nausea and vomiting.

BACKGROUND: We performed a meta-analysis on granisetron in the prevention of postoperative nausea and vomiting (PONV) and further investigated whether total results and the dose-response characteristics may be significantly affected by a single centre. METHODS: Systematically searched randomised controlled trials (RCT) using granisetron for the prevention of PONV after general anaesthesia were included in the analysis. The pooled relative risks (RR) and numbers needed to treat (NNT) with their corresponding 95%-confidence intervals (CI) were calculated. For all centres, one dominating centre and other centres pooled, comparisons were performed according to all doses, low dose ( 20 microg/kg) granisetron. RESULTS: A total of 27 RCT with 2938 patients were included in the analysis. RR (CI) to suffer from PONV with granisetron when all comparisons were considered was 0.46 (0.39-0.54), 0.7 (0.6-0.81) and 0.34 (0.28-0.41) for all doses, low and high dose, respectively. RR of the dominating centre (1867 patients) were significantly better compared to the remaining centres (1071 patients), with 0.41 (0.34-0.49) and 0.60 (0.49-0.73), respectively. In the dominating centre low dose granisetron was ineffective with a RR of 0.84 (0.68-1.04), while high dose granisetron led to a strong decrease with a RR of 0.30 (0.26-0.36). In contrast, the RR of other centres pooled for low and high dose granisetron were comparable with 0.62 (0.49-0.79) and 0.56 (0.42-0.75), respectively. CONCLUSIONS: Overall results and dose-response characteristics of meta-analyses may be significantly altered by one dominating centre. Further, if data of a dominating centre do not appear to be valid for other centres, it may seem advisable to either exclude them from the analysis or to perform sub-group analyses so that results without the data from the dominating centre are available.

Antiemetics↗
PubMed2001

What can be expected from risk scores for predicting postoperative nausea and vomiting?

Several risk scores have been developed to calculate the probability of postoperative nausea and vomiting (PONV). However, the power to discriminate which individual will suffer from PONV is still limited. Thus, we wondered how the number of predictors in a score affects the discriminating power and how the characteristics of a population--which is needed to measure the power of a score--may affect the results. For ethical reasons and to be independent from centre specific populations, we developed a computer model to simulate virtual populations. Four populations were created according to number, frequency, and odds ratio of predictors. Population I: parameters were derived from a previously published paper to verify whether calculated and reported values are in accordance. Population II: a gynaecological population was created to investigate the impact of the study setting. Populations III and IV: to meet ideal assumptions a model with up to seven predictors with an odds ratio of 2 and 3 was tested, respectively. The discriminating power of a risk score was measured by the area under a receiver operating characteristic curve (AUC) and an increase of more than 0.025 per predictor was considered to be clinically relevant. The AUC of population I was similar to those reported in clinical investigations (0.72). The study setting had a considerable impact on the discriminating power since the AUC decreased to 0.65 in a gynaecological setting. The AUC with the 'idealized' populations III and IV was at best in the range of 0.7-0.8. The inclusion of more than five predictors did not lead to a clinically relevant improvement. The currently available simplified risk scores (with four or five predictors) are useful both as a method to estimate individual risk of PONV and as a method for comparing groups of patients for antiemetic trials. They are also superior to single predictor models which are just using the patients' history of PONV or female gender alone. However, our analysis suggests that the power to discriminate which indvidual will suffer from PONV will remain imperfect, even when more predictors are considered.

Area Under Curve↗
PubMed2001

The detection of interatrial flow patency in awake and anesthetized patients: a comparative study using transnasal transesophageal echocardiography.

UNLABELLED: The Valsalva maneuver in the awake patient and the ventilation maneuver in the tracheally intubated anesthetized patient are two provocation methods to detect a patent foramen ovale (PFO) by means of contrast transesophageal echocardiography. In 60 patients undergoing posterior fossa surgery, a contrast agent was administered via a peripheral vein during a Valsalva maneuver immediately before anesthesia induction, followed by central venous administration during a ventilation maneuver in the same patients when anesthetized and endotracheally intubated. We evaluated both maneuvers with a 32-element monoplane transnasal transesophageal echocardiography probe to trace the atrial flow of the contrast agent in a 90 degrees bicaval view. A maneuver was rated positive when more than four bubbles appeared in the left atrium during the first three cardiac cycles after intrathoracic pressure release. The right atrial cross-sectional area before pressure release, and the peak septal excursion during atrial contrast opacification, were measured. McNemar's test was used to assess a paired dichotomous response on the two maneuvers for a significant difference. In 56 patients, the ventilation maneuver was significantly (P < 0.037) more often positive for PFO (n = 14) than the Valsalva maneuver (n = 7). Although there was no difference in the methods regarding the peak septal excursion, the mean right atrial area before pressure release was significantly smaller during the ventilation maneuver than during the Valsalva maneuver (11.2 +/- 3.1 cm(2) vs 14.4 +/- 3.3 cm(2), n = 42, P < 0.05). In the patients with a positive ventilation, but a negative Valsalva maneuver, the discrepancy was even larger (10.9 +/- 4.4 cm(2) vs 16.3 +/- 4.2 cm(2), n = 7, P < 0.001). We conclude that the ventilation maneuver is superior to the Valsalva maneuver in detecting PFO. Our data suggest that a peak pressure of 30 cm H(2)O during the ventilation maneuver achieves a more pronounced reduction in right atrial load and allows right atrial pressure to exceed left atrial pressure when intrathoracic pressure is released. IMPLICATIONS: A controlled ventilation maneuver in anesthetized patients immediately before posterior fossa surgery may be superior to the preoperative Valsalva maneuver in detecting a patent foramen ovale by contrast transesophageal echocardiography. This approach identifies patients at high risk for paradoxic embolism, but it is not practical for preoperative identification of patients who might benefit from patent foramen ovale closure before surgery.

Anesthesia↗