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General Anesthetic
Safety and Efficacy of Propofol Only Sedation in Oral and Maxillofacial Surgery
Phase 4
Waitlist Available
Led By Ben Davis, DDS FRCD(C)
Research Sponsored by Atlantic Center for Oral and Maxillofacial Surgery
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* ASA Class I and II patients between the ages of 16 to 50 years scheduled to have their third molars extracted under intravenous sedation.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this will be measured 30 minutes after arrival to the recovery room and then once again via phone questionnaire between 24 to 48 hours after discharge.
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Summary
The purpose of this study is to determine if the use of propofol only to achieve procedural sedation for the removal of third molars is both safe and effective.
Eligible Conditions
- Conscious Sedation
- Propofol
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after completing the surgical procedure.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after completing the surgical procedure.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse outcome
Adverse outcomes
Efficacy of Sedation
+4 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Propofol sedationExperimental Treatment1 Intervention
Patients will be undergo procedural sedation using propofol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Propofol
FDA approved
Find a Location
Who is running the clinical trial?
Atlantic Center for Oral and Maxillofacial SurgeryLead Sponsor
1 Previous Clinical Trials
300 Total Patients Enrolled
Ben Davis, DDS FRCD(C)Principal InvestigatorStaff Surgeon at "Atlantic Centre for Oral and Maxillofacial Surgery"