NCT05873465

Brief 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. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

March 13, 2023

Last Update Submit

March 26, 2026

Conditions

Cannabis Use

Outcome Measures

Primary Outcomes (1)

  • Propofol dose in milligrams

    Compare the total amount of propofol necessary to sedate patients that use cannabis with patients that do not use

    During the procedure

Secondary Outcomes (3)

  • Heart rate in beats per minute

    During the procedure

  • Blood pressure in millimeters of mercury

    During the procedure

  • Quality of sedation grading from 0 to 6 according to the Observer's Assessment of Alertness/Sedation scale

    During the procedure

Study Arms (3)

Non-users

ACTIVE COMPARATOR

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

Drug: Sedation with Midazolam, Fentanyl, and PropofolProcedure: 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.

Drug: Sedation with Midazolam, Fentanyl, and PropofolProcedure: 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.

Drug: Sedation with Midazolam, Fentanyl, and PropofolProcedure: Extraction of teeth

Interventions

Sedation with Midazolam, Fentanyl, and PropofolDRUG

Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol

Also known as: Sedation
Non-usersUsers that will stop use 12h before the procedureUsers that will stop use 72h before the procedure
Extraction of teethPROCEDURE

The necessary teeth will be extracted

Also known as: Surgical procedure
Non-usersUsers that will stop use 12h before the procedureUsers that will stop use 72h before the procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Dentistry

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Interventions

MidazolamFentanylPropofolSurgical Procedures, Operative

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2023

First Posted

May 24, 2023

Study Start

March 14, 2023

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations

US(1)