Prevention of POstoperative Nausea and Vomiting with metoclopramide and dexamethasone
| ISRCTN | ISRCTN31625370 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31625370 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/09/2005
- Registration date
- 17/10/2005
- Last edited
- 19/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Derk Olthoff
Scientific
Scientific
Liebigstr. 20
Leipzig
D-04103
Germany
| Phone | +49 (0)341 9717701 |
|---|---|
| olthoff@medizin.uni-leipzig.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | |
| Study acronym | MultiPONV |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Metoclopramide, dexamethasone |
| Primary outcome measure | 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 study start date | 12/01/2004 |
| Completion date | 14/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 3000 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 12/01/2004 |
| Date of final enrolment | 14/12/2004 |
Locations
Countries of recruitment
- Germany
Study participating centre
Liebigstr. 20
Leipzig
D-04103
Germany
D-04103
Germany
Sponsor information
University of Leipzig (Germany)
University/education
University/education
Ritterstr. 26
Leipzig
D-04109
Germany
| Phone | +49 (0)341 9730100 |
|---|---|
| kanzler@uni-leipzig.de | |
"ROR" |
https://ror.org/03s7gtk40 |
Funders
Funder type
University/education
Self-funded by the Department of Anaesthesiology and Intensive Care Medicine and by the Committee of Clinical Innovation of the University of Leipzig (Germany).
No information available
Supply of the study drugs free of charge by the manufacturers.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 12/08/2006 | Yes | No |
