Cannabis UsePhase 4NCT05873465
Cannabis Use on Sedation for Oral Surgery Procedures
A Phase 4 study testing Sedation with Midazolam, Fentanyl, and Propofol and Extraction of teeth in people with Cannabis Use, run by University of Oklahoma at 1 site in United States.
Trial summary
The use of Cannabis is increasing in the population, and the effects that this might have on different medical procedures are poorly understood. Particularly when submitted to deep sedation or general anesthesia, there is no consensus on best drugs or doses to deliver. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use
- What is being tested?
- Sedation with Midazolam, Fentanyl, and Propofol and Extraction of teeth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2023to 30 Sep 2025
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 18 years of age
- Class I or II according to the American Society of Anesthesiology (ASA)
- Need for dental extractions
- Extraction procedures with similar level of complexity
Who cannot join
- Surgical time lesser than 10 or greater than 30 minutes
- ASA status of III or greater
- BMI greater than 30 k/m2
- Pregnancy
- Use of anti-depressants, sedatives, or other mood-altering medications
- History of illicit substance abuse, alcoholism, or chronic opioid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cannabis Use on Sedation Requirements for Oral Surgery Procedures
The use of Cannabis is increasing in the population, and the effects that this might have on different medical procedures are poorly understood. Particularly when submitted to deep sedation or general anesthesia, there is no consensus on best drugs or doses to deliver. The purpose of this clinical trial is to clarify the influence of chronic cannabis use during office based general anesthesia for extraction of teeth. The procedures will be performed in the Oral and Maxillofacial Surgery Clinic at the College of Dentistry.
- Conditions
- Cannabis Use
- Being tested
- Sedation with Midazolam, Fentanyl, and Propofol, Extraction of teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation with Midazolam, Fentanyl, and PropofolDrug
Also called Sedation
Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol
Extraction of teethProcedure or surgery
Also called Surgical procedure
The necessary teeth will be extracted
| Study group | Role | What they receive |
|---|---|---|
| Non-users | Active comparator | Patients that don't use cannabis and will be submitted to sedation. Receives: Drug: Sedation with Midazolam, Fentanyl, and Propofol; Procedure: Extraction of teeth |
| Users that will stop use 72h before the procedure | Experimental | Patients that use cannabis and will stop using 72 hours before sedation. Receives: Drug: Sedation with Midazolam, Fentanyl, and Propofol; Procedure: Extraction of teeth |
| Users that will stop use 12h before the procedure | Experimental | Patients that use cannabis and will stop using 12 hours before sedation. Receives: Drug: Sedation with Midazolam, Fentanyl, and Propofol; Procedure: Extraction of teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol dose in milligrams
Compare the total amount of propofol necessary to sedate patients that use cannabis with patients that do not use
Measured: During the procedure
Secondary outcomes (3)
Heart rate in beats per minute
Compare how the heart rate behave during the procedure in each group
Measured: During the procedure
Blood pressure in millimeters of mercury
Compare how the blood pressure behave during the procedure in each group
Measured: During the procedure
Quality of sedation grading from 0 to 6 according to the Observer's Assessment of Alertness/Sedation scale
Compare the difference in sedation quality during the procedure in each group
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start14 Mar 2023
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Why it stopped: Principal Investigator failed to submit required annual review. Study was administratively closed by the IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873465
- Sponsor's protocol ID
- 15416
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2023
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cannabis Use on Sedation Requirements for Oral Surgery Procedures
- ClinicalTrials.gov ID
- NCT05873465
- Acronym / sponsor ID
- 15416
- Conditions
- Cannabis Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator failed to submit required annual review. Study was administratively closed by the IRB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 24 May 2023 (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 use of Cannabis is increasing in the population, and the effects that this might have on different medical procedures are poorly understood. Particularly when submitted to deep sedation or general anesthesia, there is no consensus on best drugs or doses to deliver. The purpose of this clinical trial is to clarify the influence of chronic cannabis use during office based general anesthesia for extraction of teeth. The procedures will be performed in the Oral and Maxillofacial Surgery Clinic at the College of Dentistry.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-users | Active comparator | Drug: Sedation with Midazolam, Fentanyl, and Propofol, Procedure: Extraction of teethPatients that don't use cannabis and will be submitted to sedation. |
| Users that will stop use 72h before the procedure | Experimental | Drug: Sedation with Midazolam, Fentanyl, and Propofol, Procedure: Extraction of teethPatients that use cannabis and will stop using 72 hours before sedation. |
| Users that will stop use 12h before the procedure | Experimental | Drug: Sedation with Midazolam, Fentanyl, and Propofol, Procedure: Extraction of teethPatients that use cannabis and will stop using 12 hours before sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years of age
- Class I or II according to the American Society of Anesthesiology (ASA)
- Need for dental extractions
- Extraction procedures with similar level of complexity
Key exclusion criteria (6 listed)
- Surgical time lesser than 10 or greater than 30 minutes
- ASA status of III or greater
- BMI greater than 30 k/m2
- Pregnancy
- Use of anti-depressants, sedatives, or other mood-altering medications
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 |
|---|---|---|
| Sedation with Midazolam, Fentanyl, and PropofolAlso: SedationPatients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol | Drug | Non-users, Users that will stop use 12h before the procedure, Users that will stop use 72h before the procedure |
| Extraction of teethAlso: Surgical procedureThe necessary teeth will be extracted | Procedure or surgery | Non-users, Users that will stop use 12h before the procedure, Users that will stop use 72h before the procedure |
Primary outcome
Propofol dose in milligrams
Time frame: During the procedure
Compare the total amount of propofol necessary to sedate patients that use cannabis with patients that do not use
3 secondary outcomes
Heart rate in beats per minute
Time frame: During the procedure
Blood pressure in millimeters of mercury
Time frame: During the procedure
Quality of sedation grading from 0 to 6 according to the Observer's Assessment of Alertness/Sedation scale
Time frame: During the procedure
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 1 Apr 2026.
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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?
A Phase 4 study testing Sedation with Midazolam, Fentanyl, and Propofol and Extraction of teeth in people with Cannabis Use, run by University of Oklahoma 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 4 inclusion and 6 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 1 Apr 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Propofol dose in milligrams (time frame: During the procedure). 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 1 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.