Support Centre
24 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

New application
Updating record

governing board
data set
letter of agreement
request information
guidance notes

[ Print-friendly version ]
Prevention of POstoperative Nausea and Vomiting with metoclopramide and dexamethasone
DOI 10.1186/ISRCTN31625370
ClinicalTrials.gov identifier
EudraCT number
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
  Email 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
  Email kanzler@uni-leipzig.de
Date applied 07/09/2005
Last edited 19/02/2008
Date ISRCTN assigned 17/10/2005
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.