NCT05220462

Remimazolam vs Midazolam Cognitive and Motor Recovery After Intravenous Conscious Sedation for Dental Extractions.

A Phase III Randomised, Triple-blind Controlled Superiority Trial of Remimazolam (CNS 7056), Compared to Midazolam, in Adults Having Lower Third Molar Wisdom Tooth Extraction Under Intravenous Conscious Sedation to Assess Cognitive and Motor Recovery at Normal Discharge Time

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

The study is looking to see if a new drug (remimazolam) that is used to sedate and relax adults (aged 18-59 years) having dental treatment is better than the current drug in use (midozolam). Intravenous sedation is where a drug is injected into a patient's hand or arm. The drug stops them feeling worried, and helps them relax. After sedation, patients wait in a recovery area until they are safe to walk but the side effects of the drug can last until the next day. A new drug has been developed that has the same sedation effect and safety, but the recovery is much quicker. The investigators think that the side effects from the new drug will have worn off by the time patients are ready to leave the hospital. Patients who are coming to Guy's Hospital to have their wisdom tooth extracted under sedation will be asked if they want to be included in the research. Patients will be randomised to receive either remimazolam of standard of care midazolam. The sedation and dental treatment will be carried out in the normal way. The patients will be asked to do will be some questionnaires and some tests which are as follows: 1. Patients are asked to listen to some words and repeat them back. This tests how well they can remember new information 2. Reaction test - Patients are asked to rest their fingers on a keypad and move their fingers when lights come on above them. This tests how quick their reactions are. 3. Symbol test- Patients are asked to draw small shapes that are linked to numbers. This tests how well they can process information. 4. Standing test- Patients are asked to stand on a platform that measures how much they are swaying back and forth. This tests how stable they are to walk. By testing people before and after the sedation the investigators can see how they recovered and compare the two drugs. The research will take place during the day case visit and involve 2 x 30 mins research assessments (before sedation and post sedation). After the post-sedation tests, participants will be discharged, followed by a telephone review 3-10 days post procedure.

Detailed description

This study will be performed as a prospective, randomised, triple blind, active controlled, parallel group, single centre study design assessing enhanced cognitive recovery in patients having third molar wisdom tooth extraction under intravenous conscious sedation with remimazolam. An active control group has been chosen using intravenous midazolam which is the current standard of care in Dentistry. 128 patients will be randomised, of which n=64 will receive remimazolam, and n=64 in the midazolam group.

Conditions

• Tooth Extraction

Interventions

Type	Name	Description
DRUG	Remimazolam	As per Remimazolam arm
DRUG	Midazolam	As per Midazolam arm

Timeline

• Start date: 2022-03-09
• Primary completion: 2024-05-01
• Completion: 2024-09-01
• First posted: 2022-02-02
• Last updated: 2023-12-05

Locations

1 site across 1 country: United Kingdom