NCT05350085

Remimazolam in the Extraction of Impacted Wisdom Teeth

A Randomized Controlled Clinical Trial of Remimazolam Benzenesulfonate Usage in the Extraction of Impacted Wisdom Teeth

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Benzodiazepines, represented by midazolam, are often used for sedation in outpatient surgery in dentistry. However, midazolam has the problems of slow consciousness recovery and long recovery time, which brings trouble to the patients. Remimazolam is a new type of ultra short acting sedative anesthetic. Compared with other similar products, remimazolam has faster effect, rapid metabolism and has no accumulation, which may mean that compared with midazolam, remimazolam has a better clinical application prospect in dental outpatient surgery.

Detailed description

The patients were randomly divided into midazolam group and remimazolam group. The onset time of drugs, postoperative recovery time, vital signs, anterograde amnesia and other complications were observed.

Conditions

• Dental Anxiety
• Sedation Complication
• Anterograde Amnesia

Interventions

Type	Name	Description
DRUG	Remimazolam besylate	① initial dose: use a micro injection pump to pump remimazolam at the rate of 50mg/h, and observe for 4 \~ 8 minutes until Ramsay Sedation grade III，then start dental operation ; ② Maintenance dose: maintain the pump speed at 5 \~ 10mg/h，adjust the pump dose to maintain the patient at Ramsay Sedation grade III. ③ Additional dose: During the operation, if the patient has body movement reaction or cannot cooperate with the dentist, local anesthetics shall be given as remedy. ④ After the operation, stop the microinjection pump.
DRUG	Midazolam	① initial dose: use a micro injection pump to pump remazolam at the rate of 30mg/h, and observe for 4 \~ 8 minutes until Ramsay Sedation grade III，then start dental operation; ② Maintenance dose: maintain the pump speed at 3 \~ 6mg/h，adjust the pump dose to maintain the patient at Ramsay Sedation grade III. ③ Additional dose: During the operation, if the patient has body movement reaction or cannot cooperate with the dentist, local anesthetics shall be given as remedy. ④ After the operation, stop the microinjection pump.

Timeline

• Start date: 2022-04-18
• Primary completion: 2023-04-01
• Completion: 2023-10-01
• First posted: 2022-04-27
• Last updated: 2023-04-07

Locations

1 site across 1 country: China