Postoperative Nausea and VomitingPhase 4NCT00151099
Safety of Preoperative Oral Administration of a High Caloric Drink With Protein
A Phase 4 study testing high caloric drink with protein in people with Postoperative Nausea and Vomiting, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The purpose of the study is to determine whether the oral administration of a high caloric drink with protein decreases the postoperative nausea and vomiting in patients with dysgnathia. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- high caloric drink with protein
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2005to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with surgery for dysgnathia
Who cannot join
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care, University Hospital Münster
Münster, D-48149
About this study
Official title: Safety of Preoperative Oral Administration of a High Caloric Drink With Protein in Patients With Dysgnathia
The purpose of the study is to determine whether the oral administration of a high caloric drink with protein decreases the postoperative nausea and vomiting in patients with dysgnathia.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- high caloric drink with protein
- Keywords
- preoperative nutrition, postoperative nausea and vomiting, Dysgnathia, anesthesia
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high caloric drink with proteinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric residual at induction of anesthesia
Secondary outcomes (2)
postoperative wellness
thermoregulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startSep 2005
- Study completionDec 2007 (estimated)
Why it stopped: There is no possibility to reach the target patient number within the set time frame
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Christiane Goeters, MD, Principal investigator, Department of Anesthesiology and Intensive Care, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151099
- Sponsor's protocol ID
- 03-Anast-05
- Status last verified
- Aug 2007
- First submitted
- 7 Sep 2005
- Last updated
- 18 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Preoperative Oral Administration of a High Caloric Drink With Protein in Patients With Dysgnathia
- ClinicalTrials.gov ID
- NCT00151099
- Acronym / sponsor ID
- 03-Anast-05
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- preoperative nutrition, postoperative nausea and vomiting, Dysgnathia, anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There is no possibility to reach the target patient number within the set time frame
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Dec 2007 (estimated)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether the oral administration of a high caloric drink with protein decreases the postoperative nausea and vomiting in patients with dysgnathia.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with surgery for dysgnathia
Key exclusion criteria (1 listed)
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high caloric drink with protein | Drug | – |
Primary outcome
gastric residual at induction of anesthesia
2 secondary outcomes
postoperative wellness
thermoregulation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane Goeters, MD principal investigator
Department of Anesthesiology and Intensive Care, University Hospital Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing high caloric drink with protein in people with Postoperative Nausea and Vomiting, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastric residual at induction of anesthesia. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.