Condition category
Signs and Symptoms
Date applied
07/09/2005
Date assigned
17/10/2005
Last edited
19/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes