Compliance, TreatmentNCT04664751
Incidence of Compliance to the ASA Preoperative Fasting Guidelines in Elective Surgery
An observational study of Compliance, Treatment, run by Mahidol University at 1 site in Thailand.
Trial summary
Patients scheduled for elective surgery with general anesthesia, regional anesthesia, or procedural sedation and analgesia will be interviewed about the last time having clear liquid drink light meal regular meal Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compliance, Treatment
- What is being tested?
- Nil-per-Oral
- Type of treatment
- Pill or oral medicine
- How many people
- 309 participants
- Where
- 1 siteThailand
- Study dates
- 26 Dec 2020to 1 May 2022
- 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: Patients scheduled for elective surgery requiring general anesthesia, regional anesthesia, or procedural sedation and analgesia
Who may be able to join
- Scheduled for elective surgery requiring general anesthesia, regional anesthesia, or procedural sedation and analgesia.
Who cannot join
- Patients with the order of NPO after midnight.
- Patients with pregnancy
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
Official title: Incidence of Compliance to the ASA Preoperative Fasting Guidelines in Elective General Surgery.
Patients scheduled for elective surgery with general anesthesia, regional anesthesia, or procedural sedation and analgesia will be interviewed about the last time having
- clear liquid drink
- light meal
- regular meal
- Conditions
- Compliance, Treatment
- Being tested
- Nil-per-Oral
- Keywords
- Compliance, NPO guidelines
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nil-per-OralOther
NPO details
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for general surgery with anesthesia | Patients scheduled for general surgery with anesthesia, receiving Nil-per-Oral order. Receives: Other: Nil-per-Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance to NPO guideline
definition of compliance include complete order of NPO for regular diet for 8 hours and soft diet for 6 hours and clear liquid for 2 hours.
Measured: 8 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start26 Dec 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compliance, TreatmentStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirilak Suksompong, Mahidol University
- Investigators
- Sirilak Suksompong, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664751
- Sponsor's protocol ID
- 997/2563(IRB2)
- Status last verified
- Jan 2023
- First submitted
- 25 Nov 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Compliance to the ASA Preoperative Fasting Guidelines in Elective General Surgery.
- ClinicalTrials.gov ID
- NCT04664751
- Acronym / sponsor ID
- 997/2563(IRB2)
- Conditions
- Compliance, Treatment
- Keywords
- Compliance, NPO guidelines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 26 Dec 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 11 Dec 2020 (actual)
- 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.
Patients scheduled for elective surgery with general anesthesia, regional anesthesia, or procedural sedation and analgesia will be interviewed about the last time having
- clear liquid drink
- light meal
- regular meal
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for general surgery with anesthesia | – | Other: Nil-per-OralPatients scheduled for general surgery with anesthesia, receiving Nil-per-Oral order. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery requiring general anesthesia, regional anesthesia, or procedural sedation and analgesia
Key inclusion criteria (1 listed)
- Scheduled for elective surgery requiring general anesthesia, regional anesthesia, or procedural sedation and analgesia.
Key exclusion criteria (2 listed)
- Patients with the order of NPO after midnight.
- Patients with pregnancy
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 |
|---|---|---|
| Nil-per-OralNPO details | Other | Patients scheduled for general surgery with anesthesia |
Primary outcome
compliance to NPO guideline
Time frame: 8 hour
definition of compliance include complete order of NPO for regular diet for 8 hours and soft diet for 6 hours and clear liquid for 2 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 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.
Sirilak Suksompong, MD principal investigator
Mahidol University
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 Compliance, Treatment, run by Mahidol University at 1 site in Thailand.
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 2 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: finished, as of the sponsor's last update on 10 Jan 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 Thailand. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
compliance to NPO guideline (time frame: 8 hour). 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 10 Jan 2023.