Prevention of POstoperative Nausea and Vomiting with metoclopramide and dexamethasone

Completed

• Conditions: Postoperative nausea and/or vomiting following inhalational or regional anaesthesia.; Signs and Symptoms; Postoperative nausea and vomiting

• Registration Number: ISRCTN31625370
• Lead Sponsor: niversity of Leipzig (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3000

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of nausea and/or vomiting within 24 hours after the end of surgery.

Secondary Outcome Measures

Name	Time	Method
1. Occurrence of post-operative nausea (PON) and vomiting (POV) separately<br>2. Frequency and severity of PON and POV<br>3. Time to first PONV event<br>4. Need of rescue medication<br>5. Frequency of hypotension and arrhythmia after intra-operative administration of the study drugs<br>6. Frequency and severity of adverse effects within 24 hours after the end of surgery: <br>6.1. Headache<br>6.2. Dizziness<br>6.3. Drowsiness<br>6.4. Dry mouth<br>6.5. Itching<br>6.6. Flush<br>6.7. Urticaria<br>6.8. Restlessness<br>6.9. Extrapyramidal symptoms<br>6.10. Dyskinesia<br>6.11. Central-anticholinergic syndrome<br>6.12. Bradycardia/tachycardia