Perioperative NutritionNCT06216977
Clears On the Day of Anesthesia Permissible up to One-Hour Prior (CODA-POP) to Surgery
A study testing Clear Liquids in people with Perioperative Nutrition, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to assess whether residual gastric volumes in patients who receive clear liquids one hour prior to time of procedure is non-inferior compared to patients who are NPO past midnight, to compare efficiency and flexibility of operating room scheduling between two fasting conditions, to assess… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Nutrition
- What is being tested?
- Clear Liquids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2024to 1 Jul 2024
- Phase
- Interventional
- 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
Who may be able to join
- Undergoing laparoscopic cholecystectomy during the day or night of a weekday (including those consented on a Friday who get postponed to a weekend surgery start time).
- Modified rapid sequence intubation (mRSI)
Who cannot join
- History of reflux disease
- History of hiatal hernia
- History of esophageal disease
- History of gastroparesis
- Known history of difficult airway or planned fiberoptic intubation
- HbA1c greater than 12
Show all 10Show fewer
- Pregnant women
- Prisoner
- Procedures conducted on weekends and holidays
- Emergency or non-elective procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: CODA-POP Surgery: Clears On the Day of Anesthesia Permissible up to One-Hour Prior to Surgery - A Prospective Randomized and Blind Trial
The purpose of this study is to assess whether residual gastric volumes in patients who receive clear liquids one hour prior to time of procedure is non-inferior compared to patients who are NPO past midnight, to compare efficiency and flexibility of operating room scheduling between two fasting conditions, to assess patient satisfaction and post-operative nausea, vomiting, pain, hunger and thirst.
and to assess wound healing and post-operative complication rates.
- Conditions
- Perioperative Nutrition
- Being tested
- Clear Liquids, Standard of Care
- Keywords
- Nil Per Os (NPO), stomach volume, gastric volume, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear LiquidsOther
Participants will not take anything by mouth after midnight the day before surgery but will be given 12 ounce clear liquid (Sugar-free Gatorade) at bedside at the pre-operative holding area
Standard of CareOther
Participants will not take anything my mouth after midnight day before surgery
| Study group | Role | What they receive |
|---|---|---|
| Clear Liquids Arm | Experimental | Not described Receives: Other: Clear Liquids |
| Standard Of Care | Active comparator | Not described Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Gastric Volume in mL/kg
Measured: At time of intubation (about 1 hour after fluid intake)
Secondary outcomes (8)
Number of participants with observed emesis
Measured: During perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours)
Number of participants with subjective pre-operative nausea
Measured: at baseline
Number of participants with subjective post-operative nausea
Measured: within 24 hours of surgery
Number of participants with production of oropharyngeal secretions
Measured: During the perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours)
Number of participants with wound dehiscence
Measured: postoperative follow up appointment (about 1 month after surgery)
Number of participants with intraoperative complications
Measured: From start of surgery to end of surgery
Amount of post-operative pain medications needed
Measured: at first clinic appointment (about 1 month after surgery)
Overall patient satisfaction as assessed by the Press-Ganey Questionnaire
This is a 10 item questionnaire and each is scored from 1(very poor) to 5(very good) , maximum score of 50 a higher number indicating better outcome
Measured: within 48-96 hours of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start20 Jan 2024 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Why it stopped: PI passed away
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative NutritionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yafen liang, The University of Texas Health Science Center, Houston
- Investigators
- George Williams, MD, FASA, FCCM, FCCP, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216977
- Sponsor's protocol ID
- HSC-MS-23-0868
- Status last verified
- Sep 2025
- First submitted
- 10 Jan 2024
- Last updated
- 3 Oct 2025
- 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 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CODA-POP Surgery: Clears On the Day of Anesthesia Permissible up to One-Hour Prior to Surgery - A Prospective Randomized and Blind Trial
- ClinicalTrials.gov ID
- NCT06216977
- Acronym / sponsor ID
- HSC-MS-23-0868
- Conditions
- Perioperative Nutrition
- Keywords
- Nil Per Os (NPO), stomach volume, gastric volume, Aspiration
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI passed away
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 20 Jan 2024 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 22 Jan 2024 (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.
The purpose of this study is to assess whether residual gastric volumes in patients who receive clear liquids one hour prior to time of procedure is non-inferior compared to patients who are NPO past midnight, to compare efficiency and flexibility of operating room scheduling between two fasting conditions, to assess patient satisfaction and post-operative nausea, vomiting, pain, hunger and thirst.
and to assess wound healing and post-operative complication rates.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clear Liquids Arm | Experimental | Other: Clear Liquids |
| Standard Of Care | Active comparator | Other: Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing laparoscopic cholecystectomy during the day or night of a weekday (including those consented on a Friday who get postponed to a weekend surgery start time).
- Modified rapid sequence intubation (mRSI)
Key exclusion criteria (10 listed)
- History of reflux disease
- History of hiatal hernia
- History of esophageal disease
- History of gastroparesis
- Known history of difficult airway or planned fiberoptic intubation
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 |
|---|---|---|
| Clear LiquidsParticipants will not take anything by mouth after midnight the day before surgery but will be given 12 ounce clear liquid (Sugar-free Gatorade) at bedside at the pre-operative holding area | Other | Clear Liquids Arm |
| Standard of CareParticipants will not take anything my mouth after midnight day before surgery | Other | Standard Of Care |
Primary outcome
Residual Gastric Volume in mL/kg
Time frame: At time of intubation (about 1 hour after fluid intake)
8 secondary outcomes
Number of participants with observed emesis
Time frame: During perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours)
Number of participants with subjective pre-operative nausea
Time frame: at baseline
Number of participants with subjective post-operative nausea
Time frame: within 24 hours of surgery
Number of participants with production of oropharyngeal secretions
Time frame: During the perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours)
Number of participants with wound dehiscence
Time frame: postoperative follow up appointment (about 1 month after surgery)
Number of participants with intraoperative complications
Time frame: From start of surgery to end of surgery
Amount of post-operative pain medications needed
Time frame: at first clinic appointment (about 1 month after surgery)
Overall patient satisfaction as assessed by the Press-Ganey Questionnaire
Time frame: within 48-96 hours of surgery
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 3 Oct 2025.
- 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.
George Williams, MD, FASA, FCCM, FCCP principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear Liquids in people with Perioperative Nutrition, run by The University of Texas Health Science Center, Houston 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 2 inclusion and 10 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 3 Oct 2025. 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?
Residual Gastric Volume in mL/kg (time frame: At time of intubation (about 1 hour after fluid intake)). 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 3 Oct 2025.