General SurgeryNCT02940236
Gastric Volumes After Oral Multimodal Analgesia in the Pre-operative Setting: A Prospective Case Series
An observational study of General Surgery, run by Mayo Clinic at 1 site in United States.
Trial summary
To assess possible risk of aspiration with pre-operative oral medications taken with "sips" of water (100ml). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Surgery
- What is being tested?
- Ultrasound
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Feb 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients scheduled for undergo surgical procedure
Who may be able to join
- Patients able to take prescribed oral multimodal analgesia as per standard of care
Who cannot join
- BMI > 40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastric Volumes After Oral Multimodal Analgesia in the Pre-operative Setting
To assess possible risk of aspiration with pre-operative oral medications taken with "sips" of water (100ml).
- Conditions
- General Surgery
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
Before and after patient receives oral multimodal analgesia as per standard of care, two ultrasound scans will be performed (10 minutes apart for each time element).
| Study group | Role | What they receive |
|---|---|---|
| Multimodal analgesia | Patients scheduled for general surgery and requiring multimodal analgesia in preoperative period. Receives: Other: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral multimodal analgesia and gastric volume
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elird Bojaxhi, M.D., Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940236
- Sponsor's protocol ID
- 16-002313
- Status last verified
- Mar 2023
- First submitted
- 19 Oct 2016
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Volumes After Oral Multimodal Analgesia in the Pre-operative Setting
- ClinicalTrials.gov ID
- NCT02940236
- Acronym / sponsor ID
- 16-002313
- Conditions
- General Surgery
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 20 Oct 2016 (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.
To assess possible risk of aspiration with pre-operative oral medications taken with "sips" of water (100ml).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal analgesia | – | Other: UltrasoundPatients scheduled for general surgery and requiring multimodal analgesia in preoperative period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients scheduled for undergo surgical procedure
Key inclusion criteria (1 listed)
- Patients able to take prescribed oral multimodal analgesia as per standard of care
Key exclusion criteria (1 listed)
- BMI > 40
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 |
|---|---|---|
| UltrasoundBefore and after patient receives oral multimodal analgesia as per standard of care, two ultrasound scans will be performed (10 minutes apart for each time element). | Other | Multimodal analgesia |
Primary outcome
Oral multimodal analgesia and gastric volume
Time frame: Baseline
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 24 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Surgery, run by Mayo Clinic at 1 site in United States.
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 24 Mar 2023. 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 United States. 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.
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?
Oral multimodal analgesia and gastric volume (time frame: Baseline). 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 24 Mar 2023.