Cannabis Use on Sedation for Dental Procedures

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Oklahoma

Must not be taking: Antidepressants, Sedatives, Mood-altering

Disqualifiers: Pregnancy, Substance abuse, Alcoholism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how regular cannabis use affects sedation during dental procedures like tooth extractions. Researchers aim to determine how Propofol, a common sedative, works for regular cannabis users. The study compares non-cannabis users with those who stop using cannabis 72 hours and 12 hours before their procedure. Ideal candidates for this trial are individuals needing dental extractions who regularly use cannabis but are not on sedatives or similar medications. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

If you are taking anti-depressants, sedatives, or other mood-altering medications, you will not be eligible to participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What is the safety track record for these treatments?

Research shows that cannabis use can affect dental treatments, particularly when sedation is involved. Some studies suggest that cannabinoids, the active ingredients in cannabis, can reduce pain and anxiety after surgery, potentially leading to reduced opioid use. However, cannabis use has also been linked to dental issues like cavities and gum disease.

Propofol, the sedation drug used in this trial, is commonly used for anesthesia and is generally considered safe. It has been used in many medical procedures for a long time. While Propofol is usually well-tolerated, it can cause side effects such as low blood pressure or breathing issues during use.

This trial examines how cannabis use might affect sedation with Propofol. Participants are asked to stop using cannabis before the procedure to better understand its impact. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores how cannabis use might affect sedation needed for dental procedures, specifically with propofol. Typically, propofol is used effectively for sedation, but its interaction with cannabis isn't well understood. This trial looks at patients who use cannabis and stop either 72 hours or 12 hours before their dental procedure. Understanding these interactions could lead to more tailored sedation protocols, potentially improving safety and effectiveness for those who regularly use cannabis. This research could pave the way for more personalized healthcare, ensuring optimal sedation management for cannabis users.

What evidence suggests that this trial's treatments could be effective for sedation during dental procedures?

Research shows that people who use cannabis might require more propofol for sedation compared to non-users. This trial will compare different groups: non-users of cannabis, users who stop 72 hours before the procedure, and users who stop 12 hours before the procedure. Both cannabis users and non-users can achieve effective sedation, but cannabis users might find it harder to reach full sedation. However, this difference wasn't significant enough to rule out chance. Overall, propofol effectively sedates, but cannabis use might influence the required dosage. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need teeth extracted and are generally healthy (ASA Class I or II). It's specifically looking at how chronic cannabis use affects sedation during these procedures. People with more complex dental issues or other health problems that could complicate sedation aren't eligible.

Inclusion Criteria

I need teeth removed.

I am older than 18 years.

I am in good or mild systemic disease according to ASA standards.

Exclusion Criteria

BMI greater than 30 k/m2

Pregnancy

History of illicit substance abuse, alcoholism, or chronic opioid use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo oral surgery procedures with sedation, comparing cannabis users and non-users

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cannabis
• Fentanyl
• Midazolam
• Propofol

Trial Overview The study is testing the effects of regular cannabis use on how well common sedatives (Midazolam, Fentanyl, Propofol) work during tooth extractions. Patients will receive these medications in a controlled clinical setting at the College of Dentistry's Oral and Maxillofacial Surgery Clinic.

How Is the Trial Designed?

Group I: Users that will stop use 72h before the procedure Experimental Treatment 2 Interventions

Patients that use cannabis and will stop using 72 hours before sedation.

Group II: Users that will stop use 12h before the procedure Experimental Treatment 2 Interventions

Patients that use cannabis and will stop using 12 hours before sedation.

Group III: Non-users Active Control 2 Interventions

Patients that don't use cannabis and will be submitted to sedation.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Published Research Related to This Trial

In a study of 318 patients undergoing endoscopy, those with self-reported cannabis exposure required significantly higher doses of propofol for sedation compared to those without cannabis use, indicating a potential drug interaction.

Daily cannabis users needed even more propofol than those who used cannabis less frequently, and there were procedural complications in the cannabis-exposed group, highlighting the importance of considering cannabis use in sedation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High quantities: Evaluating the association between cannabis use and propofol anesthesia during endoscopy. Imasogie, N., Rose, RV., Wilson, A.[2021]

A review of 250 medical records revealed that regular cannabis users required significantly higher doses of sedation medication during endoscopic procedures compared to non-users, indicating a potential impact of cannabis on sedation needs.

Understanding a patient's cannabis use is crucial for healthcare providers to effectively plan sedation strategies and assess risks associated with increased medication dosages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Cannabis Use on Sedation Requirements for Endoscopic Procedures. Twardowski, MA., Link, MM., Twardowski, NM.[2022]

The legalization of cannabis is leading to more patients using it, which raises concerns about its interaction with Propofol anesthesia, particularly during oropharyngeal procedures.

The study reports three cases of cannabis-induced hypersalivation after Propofol administration, highlighting a potential risk of suffocation during procedures and suggesting the need for careful management of patients using cannabis before anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Cannabis Intoxication and Propofol-Induced Salivation: Causes and Considerations. Derise, A., Ford, C., Hafiz, N., et al.[2022]

The new patient-maintained propofol system for conscious sedation in dentistry was found to be safe, with no instances of over-sedation and a mean lowest oxygen saturation of 94% among the 20 patients studied.

Patient and surgeon satisfaction levels were consistently high, indicating that the system effectively allowed patients to control their sedation during oral surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-maintained sedation for oral surgery using a target-controlled infusion of propofol - a pilot study. Leitch, JA., Sutcliffe, N., Kenny, GN.[2013]

Cannabis users require significantly higher doses of propofol and fentanyl for anesthesia and pain management, indicating that their tolerance to these medications may be increased.

There is a higher risk of tachycardia and cardiovascular complications in patients who use cannabis, suggesting that healthcare providers should routinely inquire about cannabis use before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effects of cannabis and cannabinoids on anesthesia and analgesia during the perioperative period]. Kraft, B., Stromer, W.[2020]

In a pilot study involving 35 healthy adults, there was no significant difference in the effectiveness of local anesthesia between chronic marijuana users and nonusers, with 88% of nonusers and 61% of users achieving successful anesthesia.

Both groups experienced similar onset and duration of anesthesia, suggesting that marijuana use does not adversely affect the efficacy of local anesthetics like lidocaine in dental procedures, although larger studies are needed for more conclusive results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Anesthetic Efficacy in Marijuana Users and Nonusers: A Pilot Study. Moran, MC., Heaton, LJ., Leroux, BG., et al.[2023]

In a study of 344 uncooperative children undergoing dental treatment with intravenous sedation using propofol, the most common complication was decreased oxygen saturation, affecting 25 children (7.3%).

Risk factors for complications included coughing during treatment and longer treatment duration, with 10.2% of cases experiencing temporary interruptions due to coughing, but no serious complications were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of deep intravenous propofol sedation in the dental treatment of children in the outpatient department. Wu, X., Liu, Y., Li, B., et al.[2023]

Delta9-THC, when administered at 50 mg/kg, significantly reduced the sedative effects of propofol (50 mg/kg), indicating an antagonistic interaction that prolonged the time to sedation on the rota-rod test.

The study demonstrated that this antagonistic effect is dose-dependent, as increasing the propofol dose to 100 mg/kg restored sedation, highlighting the complex interaction between Delta9-THC and sedative agents like propofol and thiopental.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propofol sedation is reduced by delta9-tetrahydrocannabinol in mice. Brand, PA., Paris, A., Bein, B., et al.[2018]

There is an observed increase in the total dose of propofol required during endoscopic procedures for patients who use cannabis, indicating a potential interaction between cannabis and propofol.

This issue has not been previously documented in existing data, raising concerns about the implications for patient safety and anesthesia management in cannabis users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of assessing for cannabis use prior to propofol sedation for endoscopy. Cerezo Ruiz, A.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9601225/

Cannabidiol in Dentistry: A Scoping Review - PMC CBD was shown to enhance the healing process of common ulcers by reducing the number of colony counts of bacterial strains in dental plaque ...

2. ada.org ada.org/resources/ada-library/oral-health-topics/cannabis-oral-health-effects

Cannabis: Oral Health Effects Additionally, a 2023 study reported that cannabis users required more intravenous anesthetic agents (i.e., general anesthesia) than non-cannabis ...

3. jpccr.eu jpccr.eu/pdf-191337-114559?filename=The%20role%20of%20THC%20and%20CBD.pdf

The role of THC and CBD in dentistry – a review of impacts ... However, adverse effects, such as increased risks of dental caries, periodontal disease, and potential oral cancers, have been noted, ...

4. joma.amegroups.org joma.amegroups.org/article/view/5525/html

Marijuana and cannabinoid use in clinical oral and ... In total, two studies found that cannabinoids may improve pain (9,10), while two studies failed to demonstrate improved pain control with cannabinoids (11,12).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9773404/

Local Anesthetic Efficacy in Marijuana Users and Nonusers A total of 88% of nonusers and 61% of marijuana users were successfully anesthetized; however, that difference lacked statistical significance (P = .073). Both ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12396733/

Cannabis: What We Use, Why It Matters, and When It Is ... Cannabinoids can reduce postoperative pain and anxiety and possibly opioid consumption in oral and maxillofacial surgery, but preoperative use ...

7. aaoms.org aaoms.org/wp-content/uploads/2024/04/cannabis_patient_anesthesia_clinical_paper.pdf

Clinical Paper Future research may provide improved insights into how THC interacts with other medications, including anesthetics used in office- based sedation and general ...