Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients

Peking University81 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Sedation Complication Midazolam Remimazolam

Interventions

FentanylDRUG

50ug Fentanyl intravenously

FlurbiprofenDRUG

50mg Fentanyl intravenously

MidazolamDRUG

2.5mg midazolam in 2ml normal saline intravenously

Remimazolam

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

Peking University Hospital of Stomatology

Beijing, Beijing Municipality, China

Zijian Guo

Haidian, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: Day 0

Secondary Outcomes

Time to reach ideal sedation

Time to reach Modified Observer Assessment of Sedation Score (MOAA/S) ≤ 3 after drug administration

Time frame: Day 0

Differences in blood pressure between the two groups

Differences in blood pressure during the operation between the two groups

Time frame: Day 0

Differences in heart rate between the two groups

Differences in heart rate during the operation between the two groups

Time frame: 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

Time frame: Day 0

Deepest sedation of MOAA/S

The lowest intraoperative sedation depth of MOAA/S

Time frame: Day 0

Deepest sedation of Bispect ral index(BIS) value

The lowest intraoperative sedation depth of BIS value

Time frame: Day 0

Recovery of orientation

Time from the end of the treatment to the recovery of orientation

Data from ClinicalTrials.gov

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