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11 February 2012
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| [ Print-friendly version ] |
| Prevention of POstoperative Nausea and Vomiting with metoclopramide and dexamethasone |
| ISRCTN | ISRCTN31625370 |
| ClinicalTrials.gov identifier | |
| Public title | Prevention of POstoperative Nausea and Vomiting with metoclopramide and dexamethasone |
| Scientific title | |
| Acronym | MultiPONV |
| Serial number at source | N/A |
| Study hypothesis | A prophylactic treatment of postoperative nausea and vomiting consisting of an optimal dosage of metoclopramide combined with dexamethasone increases effectiveness and lowers side effects. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Postoperative nausea and/or vomiting following inhalational or regional anaesthesia. |
| Participants - inclusion criteria |
1. Age greater than 18 years
2. Patient receives balanced anaesthesia (with intubation) or spinal, peridural, or combined spinal epidural anaesthesia for any of the following surgeries: 2.1. Hysterectomy 2.2. Cholecystectomy 2.3. Hernia repair 2.4. Otorhinolaryngological surgery 2.5. Thyroid surgery 2.6. Total endoprothesis of the hip or knee 2.7. Arthroscopy 3. Patient is able to answer questions regarding symptoms (taking his/her physical, emotional and mental constitution, understanding and compliance into consideration) 4. Informed consent in writing |
| Participants - exclusion criteria |
1. Anaesthesiological risk level of American Society of Anaesthesiologists (ASA) IV
2. Presence of at least one of the following cardiac risk factors: 2.1. Unstable angina pectoris 2.2. Heart failure with New York Heart Association (NYHA) greater than or equal to III and/or left ventricular ejection fraction (LVEF) less than 40% 2.3. Atrioventricular block grade II or III 3. Current treatment with any of the following: 3.1. Study medication 3.2. Other anti-emetic drugs except ranitidine 3.3. Selective serotonin reuptake inhibitors (SSRIs) 3.4. Monoamine oxidase (MAO) inhibitors 3.5. Tricyclic antidepressants 3.6. Antiarrhythmics class I or III 4. Disposition of the patient to malignant hyperthermia, or known occurrence thereof 5. History of any of the following diseases: 5.1. Parkinson's disease and other extrapyramidal-motoric impairment 5.2. Hepatic insufficiency (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] greater than 2 x upper normal value [UNV]) 5.3. Renal insufficiency (Creatinine greater than 2 x UNV) 5.4. Phaeochromocytoma 5.5. Mechanical ileus 5.6. Epilepsy 6. Known anaphylaxis following any of the study drugs 7. Pregnancy or breast feeding 8. Participation in another therapeutic trial 9. Planned or foreseeable post-operative application of propofol 10. Planned or foreseeable post-operative artificial respiration 11. Planned or foreseeable leaving of a stomach tube post-operatively |
| Anticipated start date | 12/01/2004 |
| Anticipated end date | 14/12/2004 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 3000 |
| Interventions | The patients were randomised to receive either of 0, 10, 25 or 50 mg metoclopramide in addition to 8 mg dexamethasone. |
| Primary outcome measure(s) | Occurrence of nausea and/or vomiting within 24 hours after the end of surgery. |
| Secondary outcome measure(s) |
1. Occurrence of post-operative nausea (PON) and vomiting (POV) separately
2. Frequency and severity of PON and POV 3. Time to first PONV event 4. Need of rescue medication 5. Frequency of hypotension and arrhythmia after intra-operative administration of the study drugs 6. Frequency and severity of adverse effects within 24 hours after the end of surgery: 6.1. Headache 6.2. Dizziness 6.3. Drowsiness 6.4. Dry mouth 6.5. Itching 6.6. Flush 6.7. Urticaria 6.8. Restlessness 6.9. Extrapyramidal symptoms 6.10. Dyskinesia 6.11. Central-anticholinergic syndrome 6.12. Bradycardia/tachycardia |
| Sources of funding |
Self-funded by the Department of Anaesthesiology and Intensive Care Medicine and by the Committee of Clinical Innovation of the University of Leipzig (Germany).
Supply of the study drugs free of charge by the manufacturers. |
| Trial website | |
| Publications | Results in http://www.ncbi.nlm.nih.gov/pubmed/16861255 |
| Contact name | Prof Derk Olthoff |
| Address | Liebigstr. 20 |
| City/town | Leipzig |
| Zip/Postcode | D-04103 |
| Country | Germany |
| Tel | +49 (0)341 9717701 |
| Fax | +49 (0)341 9717709 |
| olthoff@medizin.uni-leipzig.de | |
| Sponsor | University of Leipzig (Germany) |
| Address | Ritterstr. 26 |
| City/town | Leipzig |
| Zip/Postcode | D-04109 |
| Country | Germany |
| Tel | +49 (0)341 9730100 |
| Fax | +49 (0)341 9730109 |
| kanzler@uni-leipzig.de | |
| Date applied | 07/09/2005 |
| Last edited | 19/02/2008 |
| Date ISRCTN assigned | 17/10/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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