Use of Remimazolam and Fentanyl for Procedural Sedation in Patients Undergoing Dental Extractions

Sedation Methods for Dental Extractions

K
Kyle Kramer

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
40 participants needed
1 Location

Brief description of study

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.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential subjects will be patients who are scheduled for dental extractions under sedation in the IUSD Oral Surgery Clinic at Indiana University Hospital. Recruitment will occur chairside during the consultation appointment.

Detailed description of study

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).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Healthy
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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)

This study investigates the use of a combination of two sedation drugs, remimazolam and fentanyl, for patients undergoing dental extractions. The purpose is to determine if these drugs can effectively sedate patients during procedures scheduled to last 30 minutes or less. While these drugs have been used in other short-duration procedures, their combined use in dental extractions is being studied for the first time.

Participants in this study will receive the combined sedation drugs during their dental extraction procedure. After the procedure, they will be asked to answer survey questions about their experience. This will happen once in person after the extraction and again by telephone about 24 hours later.

  • Who can participate: Participants must be 18 years or older, healthy (ASA class 1 or 2), and scheduled for dental extractions under sedation. They must not have allergies to the sedation drugs or negative history with IV sedation.
  • Study details: Participants will receive sedation during their extraction and complete surveys about their experience afterward.
Updated on 25 Aug 2025. Study ID: IUSD-IIR-DENTAL-EXTRACTIONS, 22891
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only