search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Observational study;
Outcome study in daily clinical practice concerning postoperative nausea and vomiting.



- candidate number2836
- NTR NumberNTR1119
- ISRCTNGeen aanvraag/Observational study
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-okt-2007
- Secondary IDsN/A 
- Public TitleObservational study;
Outcome study in daily clinical practice concerning postoperative nausea and vomiting.
- Scientific TitleObservational study;
Outcome study in daily clinical practice concerning postoperative nausea and vomiting.
- ACRONYMN/A
- hypothesisFrequently people experience nausea and vomiting following surgery. There are several pharmacologic interventions possible; there is no rational evidence-based approach available. In this study the current therapy regaring PONV and its efficacy in the Medical Center Alkmaar will be described. The results of this study can be used as a basis for improvement.
- Healt Condition(s) or Problem(s) studiedPostoperative nausea and vomiting (PONV)
- Inclusion criteria1. Gynaecologic, galbladder or ear surgery;
2. >18 years of age.
- Exclusion criteria1. Language barrier;
2. emergency operation;
3. mental illness;
4. postoperative ICU care necessary.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-jul-2007
- planned closingdate1-dec-2007
- Target number of participants90
- InterventionsN/A
- Primary outcome1. Description of the current therapy regarding PONV (use of anti-emetics);
2. Description of the efficacy of the current therapy (occurence of nausea and vomiting).
- Secondary outcome1. Description of differences in therapy and occurence of PONV for different types of surgery;
2. Relation between occurence of PONV and differences in patientcharacteristics.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES W. Graaf de
- CONTACT for SCIENTIFIC QUERIES W. Graaf de
- Sponsor/Initiator Medical Centre Alkmaar, Hospital Pharmacy
- Funding
(Source(s) of Monetary or Material Support)
Medical Centre Alkmaar, Hospital Pharmacy
- Publications1. Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs 2000;59:213-243;
2. Nederlandse Vereniging voor Anesthesiologie, i. s. m. Kwaliteitsinstituut voor de Gezondheidszorg CBO. Richtlijn Postoperatieve pijnbehandeling. Aanhangsel Postoperatieve misselijkheid en braken. 2003. 2007;
3. Apfel CC, Korttila K, Abdalla M et al. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med 2004;350:2441-2451;
4. Carlisle JB, Stevenson CA. Drugs for preventing postoperative nausea and vomiting. Cochrane.Database.Syst.Rev. 2006;3:CD004125;
5. Habib AS, Gan TJ. Combination therapy for postoperative nausea and vomiting - a more effective prophylaxis? Ambul.Surg. 2001;9:59-71;
6. Wetenschappelijk Instituut Nederlandse Apothekers. Informatorium Medicamentorum. 2005;
7. Habib AS, Gan TJ. Evidence-based management of postoperative nausea and vomiting: a review. Can.J Anaesth. 2004;51:326-341;
8. Apfel CC, Laara E, Koivuranta M et al. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology 1999;91:693-700;
9. Sinclair DR, Chung F, Mezei G. Can postoperative nausea and vomiting be predicted? Anesthesiology 1999;91:109-118;
10. Koivuranta M, Laara E, Snare L et al. A survey of postoperative nausea and vomiting. Anaesthesia 1997;52:443-449;
11. Gan TJ, Meyer T, Apfel CC et al. Consensus guidelines for managing postoperative nausea and vomiting. Anesth.Analg. 2003;97:62-71;
12. Palazzo M, Evans R. Logistic regression analysis of fixed patient factors for postoperative sickness: a model for risk assessment. Br J Anaesth. 1993;70:135-140;
13. Apfel CC, Kranke P, Eberhart LH et al. Comparison of predictive models for postoperative nausea and vomiting. Br J Anaesth. 2002;88:234-240;
14. Junger A, Hartmann B, Benson M et al. The use of an anesthesia information management system for prediction of antiemetic rescue treatment at the postanesthesia care unit. Anesth.Analg. 2001;92:1203-1209;
15. Eberhart LH, Geldner G, Kranke P et al. The development and validation of a risk score to predict the probability of postoperative vomiting in pediatric patients. Anesth.Analg. 2004;99:1630-7;
16. van den Bosch JE, Kalkman CJ, Vergouwe Y et al. Assessing the applicability of scoring systems for predicting postoperative nausea and vomiting. Anaesthesia 2005;60:323-331;
17. Kalisvaart, K. Primary prevention of delirium in the elderly. 2005;
18. Engel JM, Junger A, Hartmann B et al. Performance and customization of 4 prognostic models for postoperative onset of nausea and vomiting in ear, nose, and throat surgery. J Clin Anesth. 2006;18:256-263;
19. van den Bosch, J. E. Prediction of postoperative nausea and vomiting. 2006;
20. Hilarius DL, Kloeg PHAM. Niet geneesmiddel, maar behandelingsindicatie centraal. Beoordelingssysteem voor medicijnen in ziekenhuizen. Pharmaceutisch Weekblad 2005;5:176-178;
21. Hilarius DL, Kloeg PHAM, van Haelst IMM et al. Passen en meten. Waardebepaling van specialistische geneesmiddelen. Farmanova, 2002;
22. Boogaerts JG, Vanacker E, Seidel L et al. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol.Scand. 2000;44:470-474;
23. Apfel CC, Roewer N, Korttila K. How to study postoperative nausea and vomiting. Acta Anaesthesiol.Scand. 2002;46:921-928.
- Brief summaryFrequently people experience nausea and vomiting following surgery. There are several pharmacologic interventions possible; there is no rational evidence-based approach available. In this study the current therapy regarding PONV and its efficacy in the Medical Center Alkmaar will be described. The results of this study can be used as a basis for improvement. The possible improvement will be studied in follow-up research.
- Main changes (audit trail)
- RECORD25-okt-2007 - 13-jan-2010


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl