WithdrawnPhase 4

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

Stopped: No one was enrolled to date and the sponsor requested the study be withdrawn

United States0Started 2025-07-31

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Primary Outcome Measure for IV Sedation for completion of Surgery using successful extraction of teeth (1)

Timeframe: 30 minutes extraction period at the end of surgery

Primary Outcome Measure for IV Sedation for completion of Surgery (2) using MOAA/s scores (

Timeframe: 30 minutes extraction period at the end of surgery

Primary Outcome Measure for IV Sedation for completion of Surgery determined by no need for rescue medications (3)

Timeframe: 30 minutes extraction period at the end of surgery

Trial details

NCT IDNCT06793358

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-27

View on ClinicalTrials.gov More Dental Extraction trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Primary Outcome Measure for IV Sedation for completion of Surgery using successful extraction of teeth (1)

Timeframe: 30 minutes extraction period at the end of surgery

Primary Outcome Measure for IV Sedation for completion of Surgery (2) using MOAA/s scores (

Timeframe: 30 minutes extraction period at the end of surgery

Primary Outcome Measure for IV Sedation for completion of Surgery determined by no need for rescue medications (3)

Timeframe: 30 minutes extraction period at the end of surgery