Use of Remimazolam and Fentanyl for Procedural Sedation in Patients Undergoing Dental Extraction
Withdrawn before enrolling · Phase 4
Conditions studied: Dental Extraction
In brief
The goal of this clinical trial is to learn if a combination of the two established sedation drugs remimazolam and fentanyl, can put the subject to sleep during a scheduled extraction procedure. The combined use of these drugs has been used in other studies involving IV sedation when the procedure is scheduled for 30 minutes or less. However, the combined use of the IV sedation drugs has not been used in a dental extraction procedure before. The main questions it aims to answer are: 1. Can the combined drugs effectively put the patient to sleep during the procedure 2. How quickly will they come out of the sedation after the procedure Participants will: 1. Receive the combined drugs during a scheduled extraction procedure anticipated to take less than 30 minutes 2. Answer survey questions related to their study experience after the extraction visit (in person) and again about 24 hours after the visit (by telephone).
Key facts
- Study ID
- NCT06793358
- Run by
- Indiana University
- People needed
- 0
- Starts
- 2025-07-31
- Expected to finish
- 2026-02-27
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Willing to read and sign the IRB (Institutional Review Board) approved informed consent document.
- Patients 18 years of age and older on the day of the surgery
- Healthy patients (ASA Physical Status class of 1 or 2)
- Dental treatment consists of planned extractions expected to be completed in 30 minutes or less using IV moderate (procedural) sedation.
You may not qualify if…
- List the criteria:
- Allergy or negative history with either of the planned sedative medications (remimazolam, fentanyl) or local anesthetics to be used for dental extractions.
- Previous negative history with the use of IV sedation medications
- Use of opioid-containing analgesics within 24 hours of surgery
- BMI >30 kg/m2
- Patients with multiple or poorly controlled medical comorbidities (i.e., hypertension, COPD (chronic obstructive pulmonary disease), heart failure, asthma, diabetes).
- Consumption within the last 24 hours of alcohol, illicit (marijuana, cocaine, etc.), opioid-containing, or other analgesic drugs.
- Other contraindications to procedural/moderate sedation (i.e., concurrent illness, failure to follow NPO (nil per os) instructions, lack of escort)
Where it is running
- Indiana University School of Dentistry (IUSD) — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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