Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients

NCT04602845 | Completed Phase 4

• 1 other identifier: PKUSSIRB-202056102
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

Brief Summary

Remimazolam Tosilate is a new short-acting benzodiazepines used in sedation. It has the advantages of rapid metabolism, quick recovery without injection pain. This study aims to compared with Midazolam, study whether Remimazolam Tosilate can achieve the same sedation effect with lower side effects on sedation maintenance period, During the recovery period of anesthesia, can Remimazolam Tosilatebe more stable and rapid.

Conditions

Sedation Complication; Midazolam; Remimazolam

Keywords

Remimazolam; Midazolam; Sedation

Outcome Measures

Primary Outcomes (1)

• Success rates of sedation

  Success rates for patients who completed outpatient treatment with sufficient depth of sedation, additional sedation medication less than 5 times /15 minutes, and without the need of propofol for further sedation.

  Day 0

Secondary Outcomes (12)

• Time to reach ideal sedation

  Day 0

• Differences in blood pressure between the two groups

  Day 0

• Differences in heart rate between the two groups

  Day 0

• Differences in basic vital signs between the two groups

  Day 0

• Deepest sedation of MOAA/S

  Day 0

Study Arms (2)

Remimazolam group

EXPERIMENTAL

Drug administration: 50ug fentanyl and 50mg flurbiprofen at the beginning of induction and pre-prepared drugs labeled "inducers", which contained 3 mg/2ml remimazolam. Successful sedation is defined as MOAA/S score less than or equal to 4 points during the whole process of the treatment. If MOAA/S score was greater than 4 points, a single dose of Remimazolam (1 mg) is allowed to deepen sedation. if three times of deepen sedation within 15 minutes still can not achieve successful sedation, this progress will define as failure sedation.

Drug: Fentanyl; Drug: Flurbiprofen; Drug: Remimazolam

Midazolam group

ACTIVE COMPARATOR

Drug administration: 50ug fentanyl and 50mg flurbiprofen at the beginning of induction and pre-prepared drugs labeled "inducers", which contained 2.5 mg/2ml midazolam. Successful sedation is defined as MOAA/S score less than or equal to 4 points during the whole process of the treatment. If MOAA/S score was greater than 4 points, a single dose of Midazolam (1 mg) is allowed to deepen sedation. if three times of deepen sedation within 15 minutes still can not achieve successful sedation, this progress will define as failure sedation.

Drug: Fentanyl; Drug: Flurbiprofen; Drug: Midazolam

Interventions

Fentanyl DRUG

50ug Fentanyl intravenously

Midazolam group; Remimazolam group

Flurbiprofen DRUG

50mg Fentanyl intravenously

Midazolam group; Remimazolam group

Midazolam DRUG

2.5mg midazolam in 2ml normal saline intravenously

Midazolam group

Remimazolam DRUG

3mg Remimazolam in 2ml normal saline intravenously

Remimazolam group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60
• BMI in 18-30Kg / m2
• ASA classification I-II level
• Sign informed consent
• Patients whose outpatient treatment time less than 1 hour
• The methods of local anesthesia including: periosteum infiltration method, periodontal ligament injection method, regional nerve block method

You may not qualify if:

• Patients who are allergic to benzodiazepines, opioids, flumazenil or have contraindications
• Long-term use of benzodiazepines
• Long-term use of opioids
• Participate in other clinical trials within 4 weeks
• Women during pregnancy or breastfeeding
• Patients who have a history of drug abuse or long-term alcohol abuse
• Patients who suffer from mental illness or unable to cooperate with the experiment

Sponsors & Collaborators

• Peking University: lead

Study Sites (2)

Peking University Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

Location

Zijian Guo

Haidian, Beijing Municipality, 100081, China

Location

MeSH Terms

Interventions

Fentanyl; Flurbiprofen; Midazolam; remimazolam

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Xudong Yang, MD

  Department of anesthesiology of peking university school of stomatology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Anesthesiology

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: October 26, 2020
• Study Start: April 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

CN (2)