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

NCT06793358 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 22891
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 1.Can the combined drugs effectively put the patient to sleep during the procedure
2. 2.How quickly will they come out of the sedation after the procedure
3. 3.Receive the combined drugs during a scheduled extraction procedure anticipated to take less than 30 minutes
4. 4.Answer survey questions related to their study experience after the extraction visit (in person) and again about 24 hours after the visit (by telephone).

Conditions

Dental Extraction

Keywords

Extraction; sedation; fentanyl; Remimazolam; dental

Outcome Measures

Primary Outcomes (3)

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

  Successful extraction of the indicated teeth (assessed at end of surgery)

  30 minutes extraction period at the end of surgery

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

  Maximum MOAA/S scores (Modified Observer's Assessment of Alertness and Sedation Score) of 2-4 during the procedure (score rande of 0 to 6 with 0 meaning no response to stimulus (assessed every 5 minutes)

  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)

  No need for rescue medications (propofol, flumazenil, naloxone).

  30 minutes extraction period at the end of surgery

Secondary Outcomes (1)

• Secondary Outcome Measure related to timing related to anesthesia length, surgery, eye opening and discharge

  30 minutes extraction period at the end of surgery

Other Outcomes (7)

• Other measured data related to sedation depth (1)

  30 minutes extraction period at the end of surgery

• Other measured data related to other rare sedation complications (2)

  30 minutes extraction period at the end of surgery

• Blood pressure during extraction period

  Every 5 minutes throughout the 30 minute extraction period

Study Arms (1)

Fentanyl and Remimazolam combined

EXPERIMENTAL

Remimazolam has received FDA approval for procedural sedation in adults undergoing procedures lasting 30 minutes or less. While remimazolam has been used in studies for procedural sedation outside of dentistry and oral surgery, there are no dental studies from the US that have assessed its safe and effect use along with fentanyl as described in the package insert. This single-armed study will assess the efficacy of FDA-approved remimazolam combined with fentanyl for procedural sedation (defined as MOAA/S score ≥2) in healthy (ASA 1 and 2) adults undergoing dental extractions expected to last 30 minutes or less. To date, there are no studies in the US that have assessed the effectiveness of remimazolam and fentanyl for procedural sedation for dental treatment, including extractions, so this is the first study of its kind.

Drug: fentanyl and Remimazolam

Interventions

fentanyl and Remimazolam DRUG

This is the first dental study that will combine these two sedation drugs

Fentanyl and Remimazolam combined

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator

Study Sites (1)

Indiana University School of Dentistry (IUSD)

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Fentanyl; remimazolam

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• kyle j kramer, DDS

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: January 27, 2025
• Study Start: July 31, 2025
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)