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

Trial Summary

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 data supports the effectiveness of cannabis and related drugs on sedation for dental procedures?

Research suggests that cannabis use may affect the dose of propofol needed for sedation, as seen in endoscopy procedures. Cannabis users might require higher doses of propofol, which is a drug used for sedation, indicating a potential interaction that could influence sedation effectiveness in dental procedures. ^{1 2 3 4 5}

Is cannabis use safe with propofol sedation for dental procedures?

Cannabis use may increase the risk of hypersalivation (excessive saliva production) when combined with propofol, which could complicate dental procedures and pose a risk of suffocation. ^{1 2 5 6 7}

How does the drug Propofol differ from other sedation options for dental procedures?

Propofol is unique because it is a fast-acting sedative often used for quick procedures, and its interaction with cannabis can increase the required dose and cause hypersalivation, which may complicate dental procedures. ^{1 2 5 8 9}

What is the purpose of this trial?

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.

Eligibility Criteria

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 have undergone medical procedures of similar complexity.

Exclusion Criteria

BMI greater than 30 k/m2

My surgery lasted less than 10 minutes or more than 30 minutes.

Pregnancy

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

High quantities: Evaluating the association between cannabis use and propofol anesthesia during endoscopy. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Chronic Cannabis Intoxication and Propofol-Induced Salivation: Causes and Considerations. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Local Anesthetic Efficacy in Marijuana Users and Nonusers: A Pilot Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Propofol sedation is reduced by delta9-tetrahydrocannabinol in mice. [2018]

5. Spain pubmed.ncbi.nlm.nih.gov

Importance of assessing for cannabis use prior to propofol sedation for endoscopy. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Patient-maintained sedation for oral surgery using a target-controlled infusion of propofol - a pilot study. [2013]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of deep intravenous propofol sedation in the dental treatment of children in the outpatient department. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of Cannabis Use on Sedation Requirements for Endoscopic Procedures. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

[The effects of cannabis and cannabinoids on anesthesia and analgesia during the perioperative period]. [2020]