The aim of the study is to investigate the surplus value of droperidol on top of het combination ondansetron and dexamethasone.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is PONV yes or no. PONV is defines as at least one time
vomited of nausea (verbal rating scale 2 or more) within 24 hours
postoperative.
Secondary outcome
Secondary endpoints are PONV after 48 and 72 hours postoperative, number of
times vomited, consumption of morfine, metoclopramide and ondansetron after 24,
48 and 72 hours postoperative and number of patients who develop delirium 72
hours postoperative.
Background summary
Postoperative nausea and vomiting (PONV) are the most common complaints after
anesthesia and surgery. Patients perceive PONV as one of the most bothersome
anesthesia related adverse effects and can be reason for longer hospitalstay.
Good profylaxis can reduce PONV. The CBO guidelines advise combination therapy
with ondansetron and dexamethason. In spite of the profylaxis there are still
patients with PONV.
Study objective
The aim of the study is to investigate the surplus value of droperidol on top
of het combination ondansetron and dexamethasone.
Study design
It's a double-blind placebo-controlled randomized study.
Postoperative patients receive a PCA pump with 50 ml morfine 5 mg/ml.
Patients in the droperidolgroup receive 2,5 mg droperidol, once added to the
morfine. In the placebo group there's no addition to the morfine.
Further antiemetic treatment is according to standard procedure.
Intervention
not applicable
Study burden and risks
not applicable
Molengracht 21
4818 CK
NL
Molengracht 21
4818 CK
NL
Listed location countries
Age
Inclusion criteria
18 years and older
postoperative analgesia by means of a PCA pump with morfine
Exclusion criteria
Pregnancy, breastfeeding, serious depression, bradycardia (<55/min), hypopotassemia, pheochromocytoma, dopamin agonist use, prolonged QT-interval, alcoholism
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-004914-16-NL |
| CCMO | NL19560.101.07 |