Prevention of POstoperative Nausea and Vomiting with metoclopramide and dexamethasone

ISRCTN	ISRCTN31625370
DOI	https://doi.org/10.1186/ISRCTN31625370
Protocol serial number	N/A
Sponsor	University of Leipzig (Germany)
Funders	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.

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

Liebigstr. 20
Leipzig
D-04103
Germany

Phone	+49 (0)341 9717701
Email	olthoff@medizin.uni-leipzig.de

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Metoclopramide, dexamethasone
Primary outcome measure(s)	Occurrence of nausea and/or vomiting within 24 hours after the end of surgery.
Key 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
Completion date	14/12/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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