Effect of Cannabis (Marijuana) on Stomach Emptying Before... | NCT05436236

Studies
Effect of Cannabis (Marijuana) on Stomach Emptying Before Surgery

NCT05436236

Sponsor

The Guthrie Clinic

Status

Withdrawn

Last Update Posted

Feb 14, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Gastric Emptying
Cannabis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator decision

Expanded Access Info

Start Date

Dec 1, 2024Estimated

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Jun 23, 2022

First Submission Date that Met QC Criteria

Jun 23, 2022

First Posted Date

Jun 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2024

Last Update Posted Date

Feb 14, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control		People who self-report that they do not use cannabis.
Cannabis		People who self-report that they use cannabis.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gastric content volume	Gastric content volume as assessed by ultrasound prior to surgery	pre-operative

Secondary Outcomes

Measure	Description	Time Frame
Frequency of cannabis use	number of times per week patient uses cannabis	3 months prior to surgery
Cannabis use (chronic yes or no)	Yes or No for chronic cannabis use

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Advanced liver or renal dysfunction
Critically ill
Emergent/urgent cases

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Neel Kapoor, DO	The Guthrie Clinic	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002189	Marijuana Abuse

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided