The use of a nasogastric (NG) tube to prevent

Transcription

1 Ambulatory Anesthesiology Section Editor: eter S. A. Glass Routine Use of Nasogastric Tubes Does Not Reduce ostoperative Nausea and Vomiting Karl-Heinz Kerger* Edward Mascha Britta Steinbrecher Thomas Frietsch Oliver C. Radke Katrin Stoecklein# Christian Frenkel** Georg Fritz Klaus Danner Routine use of a nasogastric (NG) tube has been suggested to prevent postoperative nausea and vomiting (ONV) despite conflicting data. Accordingly, we tested the hypothesis that routine use of a NG tube does not reduce ONV. Our work is based on data from a large trial of 4055 patients initially designed to quantify the effectiveness of combinations of antiemetic treatments for the prevention of ONV. This analysis uses propensity scores for case matching to ensure group comparability on baseline factors. Intraoperative NG tube use patients and perioperative NG tube use patients were respectively matched to nonuse patients on all available potential confounders. Matched-pairs were identified using propensity scores for 1032 patients with or without intraoperative NG tube use and 176 patients with or without perioperative NG tube use. The incidences of ONV in the intraoperative group were 44.4% vs 41.5% ( 0.35) with and without tube use, respectively, and 27.8% vs 31.3% ( 0.61) in the perioperative group. Our results provide evidence that routine use of a NG tube does not reduce the incidence of ONV. (Anesth Analg 2009;109:768 73) Alparslan Turan Christian C. Apfel, MD, hd For the IMACT Investigators The use of a nasogastric (NG) tube to prevent postoperative nausea and vomiting (ONV) has long been suggested in the literature. ostulated mechanisms for an effect have included decompressing the stomach and decreasing acidity. Given that the experience of the person ventilating the lungs with a face mask has been described as influencing ONV 1 and that use of histamine-antagonists can reduce ONV, 2 the routine use of a NG tube to prevent ONV appears plausible. The effect of a gastric tube reported in the literature is very heterogeneous, 3 but individual studies may be underpowered to detect a small but still clinically relevant difference. Using a dataset of more than 1000 patients, we tested the hypothesis that routine intraoperative or perioperative use of a NG tube would not affect the incidence of ONV. The primary endpoint in this analysis was incidence of ONV during the first 24 h postoperatively. From the *Department of Anesthesiology and Critical Care Medicine, Evangelian Deaconry Hospital, Freiburg, Germany; Department of Anesthesiology and Operative Critical Care Medicine, University Hospital Mannheim, Mannheim, Germany; Departments of Quantitative Health Sciences, and Outcomes Research, Cleveland Clinic, Cleveland, Ohio; Westpfalz-Klinikum GmbH, Kaiserslautern, Germany; erioperative Clinical Research Core, Department of Anesthesia and erioperative Care, University of California at San Francisco, UCSF Medical Center at Mount Zion, San Francisco, California; Klinik und oliklinik für Anästhesiologie und Intensivtherapie, University Hospital Dresden, Dresden, Germany; #Department of Anesthesiology, VU University medical center, Amsterdam, The Netherlands; **Städtisches Klinikum Lüneburg gemeinnützige GmbH, Lüneburg, Germany; Department of Anesthesiology, Intensive Care Medicine, and ain Therapy, Heart Centre Brandenburg at Bernau, Bernau, Germany; Department of Anaesthesiology, Trakya University, Edirne, Turkey; and The Outcomes Research Consortium, Department of Anesthesiology and erioperative Medicine, University of Louisville, Louisville, Kentucky. 768 Accepted for publication February 15, Supported by a grant to the erioperative Clinical Research Core from the Department of Anesthesia and erioperative Care at the University of California, San Francisco. The International Multicenter rotocol to Assess the Single and Combined Benefits of Antiemetic Interventions in a Controlled Clinical Trial of a Factorial Design (IMACT) Investigators are listed in the Appendix. Address correspondence and reprint requests to Christian C. Apfel, MD, hd, erioperative Clinical Research Core, Department of Anesthesia and erioperative Care, University of California San Francisco (UCSF), UCSF Medical Center at Mount Zion, 1600 Divisadero, C-447, San Francisco, CA Address to apfel@ponv.org or apfelc@anesthesia.ucsf.edu. Copyright 2009 International Anesthesia Research Society DOI: /ane.0b013e3181aed43b Vol. 109, No. 3, September 2009

2 Table 1. Intraoperative Nasogastric (NG) Tube Use Versus Non-Use After Matching Based on ropensity Score Intraoperative NG tube use No NG tube use Effect N Mean (sd) N Mean (sd) ropensity score (0.24) (0.24) 0.90 Years of experience of anesthesiologist a (7.1) (7.8) 0.43 atient s age (yr) a (14.1) (14.1) 0.94 Koivuranta s ONV risk score a (0.16) (0.16) 0.73 Apfel s OV risk score (0.16) (0.15) 0.34 Weight (kg) (14.2) (13.4) 0.32 Body mass index (kg/m 2 ) (4.5) (4.4) 0.58 N % N % Gender M F ASA classification a I II III Centre (all used) a #2 (largest centre) Operation category a Hernia repair Cholecystectomy Hysterectomy Thyroid surgery Breast surgery Hip replacement Knee arthroscopy Upper extremity ENT & eye surgery Other gynecologic surgery Bone surgery General surgery Surgical approach a Open abdominal Laparoscopic abdominal Other Antiemetic prophylaxis Ondansetron Dexamethasone Droperidol Anesthetic regimen a Inhal, Fent, N 2 O rop, Fent, N 2 O Inhal, Remi, N 2 O rop, Remi, N 2 O Inhal, Fent, Air rop, Fent, Air Inhal, Remi, Air rop, Remi, Air atient distribution in the intraoperative nasogastric tube use group and the no use group after matching based on propensity score. All predictors, risk factors, operations, and anesthetic regimens are distributed evenly among the groups. ONV postoperative nausea and vomiting; OV postoperative vomiting; ENT ear, nose, and throat; Inhal inhalational; rop propofol; Fent fentanyl; Remi remifentanil. a Variable used to create propensity scores. METHODS Our comparative study used data from the previously published International Multicenter rotocol to Assess the Single and Combined Benefits of Antiemetic Strategies in a Controlled Clinical Trial of Factorial Design (IMACT) 4 (Appendix). In the IMACT trial, patients were randomized in double-blind fashion and assigned to several antiemetic strategies. The insertion of the NG tube was not randomized and left to the discretion of the anesthesiologist. In patients with an intraoperative NG tube, the tube was placed after intubation, suctioned, capped, and removed under suction immediately before extubation, whereas in patients with perioperative use, it was left in place, suctioned, and capped, with intermittent suctioning for more than 24 h after surgery. In the postanesthesia care unit, the time, severity, and characteristics of ONV were recorded on standardized Vol. 109, No. 3, September International Anesthesia Research Society 769

3 Table 2. erioperative Nasogastric (NG) Tube Use Versus Non-Use After Matching Based on ropensity Score erioperative tube use No tube use N Mean (sd) N Mean (sd) ropensity score (0.26) (0.26) 0.98 Body mass index (kg/m 2 ) a (4.89) (4.66) 0.92 atient s age (yr) a (13.17) (17.35) 0.90 Anxiety before induction (VAS 0 10) a (2.41) (2.69) 0.56 Years of experience of anesthesiologist (7.89) (9.34) 0.83 Koivuranta s ONV risk score (0.17) (0.15) 0.12 Apfel s OV risk score (0.18) (0.15) 0.21 Weight (kg) (13.98) (13.09) 0.93 N % N % Gender M F ASA classification a I II III Centre #13 (largest) BIS-level according to stratification a No BIS Operation category a Hernia repair Cholecystectomy Hysterectomy ENT & eye surgery Other gynaecologic surgery Bone surgery General surgery Surgical approach a Open abdominal Laparoscopic abdominal Other Antiemetic prophylaxis Ondansetron Dexamethasone Droperidol Anaesthetic regimen a Inhal, Fent, N 2 O rop, Fent, N 2 O Inhal, Remi, N 2 O rop, Remi, N 2 O Inhal, Fent, Air rop, Fent, Air Inhal, Remi, Air rop, Remi, Air atient distribution among the perioperative ( 24 h) nasogastric tube use group and the no use group after matching based on propensity score. All predictors, risk factors, operations, and anesthetic regimens are distributed evenly among the groups. ONV postoperative nausea and vomiting; OV postoperative vomiting; ENT ear, nose, and throat; BIS Bispectral Index; Inhal inhalational; rop propofol; Fent fentanyl; Remi remifentanil. a Variable used to create propensity scores. forms. ONV was defined as the occurrence of nausea (using a severity score 0 10), vomiting/retching, or both during the first 24 h after surgery. Statistical Analysis Associations between NG tube use and three 24-h outcomes (nausea, emesis, and overall ONV) were assessed using propensity score analysis. Any baseline variable even remotely predictive of NG tube use, defined as 0.30, was included in the calculation of the propensity scores, including such factors as experience of the anesthesiologist, patient age, ONV risk score, location, surgery type, surgical approach (open versus laparoscopic), anesthetic regimen, and clinical center. Our analysis for each exposure (NG tube use versus nonuse) thus consisted of two stages. In the first stage, 770 Nasogastric Tube Use and Risk of ONV ANESTHESIA & ANALGESIA

4 all available baseline factors were used in a model to predict NG tube use (yes/no), from which each patient was assigned a predicted probability of having received a NG tube. Each patient who actually did receive a NG tube was then matched on that probability to a nonuse patient using the greedy matching algorithm 5 with a matching criterion of 0.05 propensity score units. In the second stage, we compared the matched NG tube groups (yes/no) on the outcome(s) of interest, ONV, using logistic regression analyses. Multivariable models included any covariates significant at the 0.05 level, further adjusting for any remaining imbalance on available potential confounders. Note that our multivariable analysis is based on the propensitymatched patients only and is quite distinct from a traditional multivariable model using all patients in the dataset, regardless of distribution of baseline variables. The significance level for the two-tailed 2 test was For each analysis, we performed the usual twotailed test for superiority of one treatment versus the other. We also performed a nonsuperiority analysis in which we tested the null hypothesis that NG tube use is beneficial. We defined beneficial as a reduction in the odds of having the outcome by at least 5% with NG use, corresponding to an odds ratio (OR) of 0.95 or lower. The alternative hypothesis in this one-tailed test was that the OR is 0.95, i.e., that NG tube use is either worse than nontube use (OR 1) or that it reduces the odds of the outcome no more than 5% (OR 0.95). A significant test result would thus be interpreted as NG tube use being not superior to nonuse (i.e., either equivalent or worse). The significance level for each hypothesis was No adjustment was made for assessing the three primary outcomes. SAS statistical software (Cary, NC, version 9.1) was used for all analyses. RESULTS A total of 4055 patients were initially considered for analysis: 2743 patients did not receive a NG tube, 1185 received a NG tube intraoperatively, and 127 received one intra- and postoperatively for 24 h. This initial grouping demonstrated imbalance on important baseline predictors of morbidity. ropensity scores were then used to compile a subgroup of matched NG tube use and control patients for intraoperative and 24-h postoperative use. Balance was achieved for all variables used in the propensity score matching and, innate to the methodology, also for variables that influence the risk for ONV (Tables 1 and 2). Results comparing propensity-matched intraoperative NG tube use versus controls are shown in Figure 1 and with more detail in Table 3. Intraoperative use of the NG tube use was not associated with a reduction in nausea (multivariable OR of 1.23, 0.14), vomiting (0.92, 0.64), or ONV (1.22, 0.16). The Figure 1. ropensity score matched comparison for patients with versus without intraoperative NG tube use. 24-h ONV incidence was 44.4% in patients with an intraoperative NG tube use versus 41.5% in controls, for a difference of 2.9% (95% CI 3.2%, 9.1%). erioperative NG tube use propensity score results are displayed in Table 4. There was no evidence of an association between perioperative NG tube use and reduction in nausea (0.85, 0.65), emesis (0.90, 0.83), or overall ONV (0.84, 0.64). The 24-h ONV incidence was 27.8% in patients with perioperative NG tube use versus 31.3% in controls, for a difference of 2.4% (95% CI 16.1%, 11.1%). In our nonsuperiority analyses, we rejected the null hypotheses that intraoperative NG tube use was more beneficial (i.e., superior) compared with non-ng tube use for two of the three outcomes of interest, ONV (multivariable 0.033) and nausea (multivariable 0.037), assuming that an OR between 0.95 and 1.0 represents equivalence of the two methods of care (Table 3). From these one-tailed results, we infer that the adjusted OR for perioperative NG tube use is 0.95 for ONV and nausea. Nonsuperiority was not demonstrated for perioperative NG tube use (Table 4). DISCUSSION This analysis of a large case-matched dataset with more than 1000 patients evaluating the effect of a NG tube on ONV shows no evidence of a reduction in incidence of ONV. This result seems surprising given that mechanistically every effort that reduces intragastric volume should decrease the incidence of vomiting. A meta-analysis performed by Cheatham et al. 6 identified 26 trials with 3964 patients and found no difference in the incidence of postoperative nausea but did find a decreased risk of vomiting. However, retching, which might occur instead of vomiting in the setting of an emptied stomach, was not separately accounted for in all included studies. Additionally, the effect of a gastric tube reported in the literature is so heterogeneous that no reasonable point estimates could be calculated in a Cochrane review by Nelson et al. 3 Our analysis includes a significantly larger sample size than any other previous randomized controlled Vol. 109, No. 3, September International Anesthesia Research Society 771

5 Table 3. ropensity Score Analysis a for Intraoperative Nasogastric (NG) Tube Use Outcome Model (# covariates) NG tube use No (%) Yes (%) Odds ratio b (95% CI) Superiority c (null: OR 1) Nonsuperiority d (null: OR 0.95) ONV Univariable ( ) Multivariable (8) 1.23 ( ) * Emesis Univariable ( ) Multivariable (6) 0.92 ( ) Nausea Univariable ( ) Multivariable (6) 1.22 ( ) * N 1032 for univariable and N 1029 for multivariable analyses. CI confidence interval; ONV postoperative nausea and vomiting; OR odds ratio. a Using greedy matching within 0.05 propensity score units. b Odds ratio for NG tube use versus nonuse (reference). c Two-tailed test of null hypothesis of no NG tube effect. d One-tailed test against the null hypothesis that the odds ratio of NG tube use is 0.95 (i.e., superior), where the alternative hypothesis and significant result means NG tube use odds ratio 0.95 (either equivalent to or worse than non-ng tube use, given the equivalence range of ). * Significant at Table 4. ropensity Score Analysis a for erioperative Nasogastric (NG) Tube Use Outcome Model (# covariates) NG tube use No (%) Yes (%) Odds ratio b (95% CI) Superiority d (null: OR 1) Nonsuperiority e (null: OR 0.95) ONV Univariable ( ) Multivariable (1) 0.85 ( ) Emesis Univariable ( ) Multivariable (2) 0.90 ( ) Nausea Univariable ( ) Multivariable (1) 0.84 ( ) N 166 (83/group) for univariable and N 165 for multivariable analyses. CI confidence interval; OR odds ratio. a Using greedy matching within 0.05 propensity score units. b Odds ratio for NG tube use versus nonuse (reference). c Two-tailed test of null hypothesis of no NG tube effect. d One-tailed test against the null hypothesis that the odds ratio of NG tube use is 0.95 (i.e., superior), where the alternative hypothesis and significant result means NG tube use odds ratio 0.95 (either equivalent to or worse than non-ng tube use, given the equivalence range of ). e Significant at trial and should thus be able to detect even small effects present. The main limitation of this analysis is that the original study was not randomized for the use of a gastric tube; however, to address this drawback patients were matched using a propensity score to yield groups balanced on potential baseline confounders. 7,8 In conclusion, these results provide strong evidence that the routine use of a NG tube during surgical procedures does not reduce ONV. ACKNOWLEDGMENTS The authors thank Dr. Anuj Malhotra for his careful editorial assistance. AENDIX The IMACT investigators are as follows: Steering Committee C. C. Apfel, A. Biedler, and K. Korttila. Data Management and Monitoring C. C. Apfel, E. Kaufmann, M. Kredel, A. Schmelzer, and J. Wermelt. and Data Analyses C. C. Apfel, K.-H. Kerger, and E. Mascha. Site Investigators C. C. Apfel, S. Alahuhta, F. Bach, A. Bacher, H. Bartsch, H. Bause, A. Biedler, B. Book, H. Bordon, D. Buschmann, K. Danner, O. Danzeisen, D. Detzel, L. H. J. Eberhart, H. Feierfeil, H. Forst, C. Frenkel, G. Frings, B. Fritz, G. Fritz, A. Goebel, M. Hergert, C. Heringhaus, M. Hinojosa, C. Hoehne, W. Hoeltermann, H.-B. Hopf, C. Isselhorst, R. M. Jokela, E. Kaufmann, H. Kerger, T. Kangas- Saarela,. Karjaleinen, A. Kimmich, M. Koivuranta, K. Korttila, U. Koschel,. Kranke, M. Kredel, M. Lange, F. Liebenow, W. Leidinger, M. Lucas, C. Madler, J. N. Meierhofer, F. Mertzlufft, J. Motsch, S. Muñoz, E. alencikova, A. aura, S. ohl, C. rause, R. Rincon, N. Roewer, U. Ruppert, A. Schmelzer, I. E. Schneider, R. Sneyd, Schramm, A. Soikkeli, S. Spieth, B. Steinbrecher, K. Stoecklein, M. Trick, A. Turan, S. Trenkler, I. Vedder,. Vila, J. Wermelt, K. Werthwein, W. Wilhelm, and C. Zernak. 772 Nasogastric Tube Use and Risk of ONV ANESTHESIA & ANALGESIA

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