Gastric EmptyingNCT05436236
Effect of Cannabis (Marijuana) on Stomach Emptying Before Surgery
An observational study of Gastric Emptying and Cannabis, run by The Guthrie Clinic.
Trial summary
The purpose of this research is to study the effect of cannabis (marijuana) on gastric (stomach) emptying before surgery. The study will include people who use cannabis (study group) and people who do not use cannabis (control group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Emptying, Cannabis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Dec 2026
- 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
- Adult, Older adult
Study population: Subjects 18 years and older with a planned surgery at one of two hospitals within the healthcare system, who are willing to state if they use or do not use cannabis
Who may be able to join
- Subjects 18 years and older
- Planned surgery at one of two hospitals within the healthcare system
- Willing to state if they use or do not use cannabis
- Able to read and consent on their own behalf
Who cannot join
- Cognitively impaired
- Unable to read
- Children under the age of 18
- Pregnant women - Pregnancy status will be obtained from the routine pregnancy test performed prior to surgery
- History of gastroparesis
- Gastric surgeries
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- Advanced liver or renal dysfunction
- Critically ill
- Emergent/urgent cases
About this study
Official title: Cannabis Consumption Effect on Gastric Volumes
The purpose of this research is to study the effect of cannabis (marijuana) on gastric (stomach) emptying before surgery. The study will include people who use cannabis (study group) and people who do not use cannabis (control group).
Read the detailed description
About 108 people will take part in this study (54 in the study group and 54 in the control group). Subjects will have an ultrasound of the abdomen before their scheduled surgery. The ultrasound will determine how much fluid remains in the abdomen.
Researchers will also review subjects' medical records and will include: age, body mass index, history of cannabis use including how often and how consumed, reason for surgery, and length of time without eating before surgery.
- Conditions
- Gastric Emptying, Cannabis
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | People who self-report that they do not use cannabis. | |
| Cannabis | People who self-report that they use cannabis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric content volume
Gastric content volume as assessed by ultrasound prior to surgery
Measured: pre-operative
Secondary outcomes (4)
Frequency of cannabis use
number of times per week patient uses cannabis
Measured: 3 months prior to surgery
Cannabis use (chronic yes or no)
Yes or No for chronic cannabis use
Measured: 1 year prior to surgery
Route of cannabis consumption
Categories of how cannabis is consumed (smoke, vape, other)
Measured: 3 months prior to surgery
Time since last food; Nil per os (NPO) time
Length of time patient had no food prior to surgery
Measured: 24 hours prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Why it stopped: Investigator decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric EmptyingStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neel Kapoor, DO, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436236
- Sponsor's protocol ID
- 2204-15
- Status last verified
- Feb 2024
- First submitted
- 23 Jun 2022
- Last updated
- 14 Feb 2024
- 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 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis Consumption Effect on Gastric Volumes
- ClinicalTrials.gov ID
- NCT05436236
- Acronym / sponsor ID
- 2204-15
- Conditions
- Gastric Emptying, Cannabis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigator decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Jun 2022 (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 research is to study the effect of cannabis (marijuana) on gastric (stomach) emptying before surgery. The study will include people who use cannabis (study group) and people who do not use cannabis (control group).
Detailed description
About 108 people will take part in this study (54 in the study group and 54 in the control group). Subjects will have an ultrasound of the abdomen before their scheduled surgery. The ultrasound will determine how much fluid remains in the abdomen.
Researchers will also review subjects' medical records and will include: age, body mass index, history of cannabis use including how often and how consumed, reason for surgery, and length of time without eating before surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –People who self-report that they do not use cannabis. |
| Cannabis | – | –People who self-report that they use cannabis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects 18 years and older with a planned surgery at one of two hospitals within the healthcare system, who are willing to state if they use or do not use cannabis
Key inclusion criteria (4 listed)
- Subjects 18 years and older
- Planned surgery at one of two hospitals within the healthcare system
- Willing to state if they use or do not use cannabis
- Able to read and consent on their own behalf
Key exclusion criteria (9 listed)
- Cognitively impaired
- Unable to read
- Children under the age of 18
- Pregnant women - Pregnancy status will be obtained from the routine pregnancy test performed prior to surgery
- History of gastroparesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gastric content volume
Time frame: pre-operative
Gastric content volume as assessed by ultrasound prior to surgery
4 secondary outcomes
Frequency of cannabis use
Time frame: 3 months prior to surgery
Cannabis use (chronic yes or no)
Time frame: 1 year prior to surgery
Route of cannabis consumption
Time frame: 3 months prior to surgery
Time since last food; Nil per os (NPO) time
Time frame: 24 hours prior to 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 14 Feb 2024.
- 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.
Neel Kapoor, DO principal investigator
The Guthrie Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Emptying and Cannabis, run by The Guthrie Clinic.
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 4 inclusion and 9 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 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Gastric content volume (time frame: pre-operative). 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 14 Feb 2024.