Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients

The Effects of Remimazolam Tosilate Sedation Compared With Midazolam Sedation in Dental Patients: A Double Blind, Prospective , Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Sedation Complication; Remimazolam; Midazolam
• Intervention / Treatment: Drug: Fentanyl; Drug: Flurbiprofen; Drug: Remimazolam; Drug: Midazolam

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100081
      • Peking University Hospital of Stomatology
    • Haidian, Beijing, China, 100081
      • Zijian Guo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Remimazolam group; 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; 50ug Fentanyl intravenously; Drug: Flurbiprofen; 50mg Fentanyl intravenously; Drug: Remimazolam; 3mg Remimazolam in 2ml normal saline intravenously
ACTIVE_COMPARATOR: Midazolam group; 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; 50ug Fentanyl intravenously; Drug: Flurbiprofen; 50mg Fentanyl intravenously; Drug: Midazolam; 2.5mg midazolam in 2ml normal saline intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to reach ideal sedation	Time to reach Modified Observer Assessment of Sedation Score (MOAA/S) ≤ 3 after drug administration	Day 0
Differences in blood pressure between the two groups	Differences in blood pressure during the operation between the two groups	Day 0
Differences in heart rate between the two groups	Differences in heart rate during the operation between the two groups	Day 0
Differences in basic vital signs between the two groups	Differences in blood pressure, heart rate, and BIS at different points during the operation between the two groups	Day 0
Deepest sedation of MOAA/S	The lowest intraoperative sedation depth of MOAA/S	Day 0
Deepest sedation of Bispect ral index(BIS) value	The lowest intraoperative sedation depth of BIS value	Day 0
Recovery of orientation	Time from the end of the treatment to the recovery of orientation	Day 0
Benzodiazepine dosage	Intraoperative benzodiazepine dosage	Day 0
Respiratory complication occurrence rate	Respiratory complication including: intraoperative hypoxemia, respiratory depression and other complications in the two groups.	Day 0
Discharge time	Time to be allowed to discharge after finishing the treatment	Day 0
The Hopkins Language Learning Test score	The Hopkins Language Learning Test (HVLT-R) score 15 minutes after the end the of the treatment. HVLT-R is a assessment of the patients' language learning condition , this score is from 0 to 30, the more score patients get means the better of patients' Language Learning condition.	Day 0
Usage rate of flumazenil	If the patients' MOAA/S less than 4 for more than 15 minutes, flumazenil will be used. The usage rate of flumazenil is the number of patients use flumazenil/ the number of all patients.	Day 0

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (ACTUAL): October 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 12, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Sedation; Midazolam; Remimazolam
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Fentanyl; Midazolam; Flurbiprofen
• Other Study ID Numbers: PKUSSIRB-202056102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No