Contact information
Type
Scientific
Primary contact
Prof Derk Olthoff
ORCID ID
Contact details
Liebigstr. 20
Leipzig
D-04103
Germany
+49 (0)341 9717701
olthoff@medizin.uni-leipzig.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
MultiPONV
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Postoperative nausea and/or vomiting following inhalational or regional anaesthesia.
Intervention
The patients were randomised to receive either of 0, 10, 25 or 50 mg metoclopramide in addition to 8 mg dexamethasone.
Intervention type
Drug
Phase
Not Specified
Drug names
Metoclopramide, dexamethasone
Primary outcome measures
Occurrence of nausea and/or vomiting within 24 hours after the end of surgery.
Secondary outcome measures
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
Overall trial start date
12/01/2004
Overall trial end date
14/12/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
3000
Participant 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
Recruitment start date
12/01/2004
Recruitment end date
14/12/2004
Locations
Countries of recruitment
Germany
Trial participating centre
Liebigstr. 20
Leipzig
D-04103
Germany
Sponsor information
Organisation
University of Leipzig (Germany)
Sponsor details
Ritterstr. 26
Leipzig
D-04109
Germany
+49 (0)341 9730100
kanzler@uni-leipzig.de
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Self-funded by the Department of Anaesthesiology and Intensive Care Medicine and by the Committee of Clinical Innovation of the University of Leipzig (Germany).
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Supply of the study drugs free of charge by the manufacturers.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/16861255
Publication citations
-
Results
Wallenborn J, Gelbrich G, Bulst D, Behrends K, Wallenborn H, Rohrbach A, Krause U, Kühnast T, Wiegel M, Olthoff D, Prevention of postoperative nausea and vomiting by metoclopramide combined with dexamethasone: randomised double blind multicentre trial., BMJ, 2006, 333, 7563, 324, doi: 10.1136/bmj.38903.419549.80.