Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients

Sedation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602845
• Other study ID #: PKUSSIRB-202056102
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Midazolam
• Remimazolam
• Sedation Complication

Intervention

Drug:
• Fentanyl
50ug Fentanyl intravenously
• Flurbiprofen
50mg Fentanyl intravenously
• Midazolam
2.5mg midazolam in 2ml normal saline intravenously
• Remimazolam
3mg Remimazolam in 2ml normal saline intravenously

Locations

Country	Name	City	State
China	Peking University Hospital of Stomatology	Beijing	Beijing
China	Zijian Guo	Haidian	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to reach ideal sedation	Time to reach Modified Observer Assessment of Sedation Score (MOAA/S) = 3 after drug administration	Day 0
Secondary	Differences in blood pressure between the two groups	Differences in blood pressure during the operation between the two groups	Day 0
Secondary	Differences in heart rate between the two groups	Differences in heart rate during the operation between the two groups	Day 0
Secondary	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
Secondary	Deepest sedation of MOAA/S	The lowest intraoperative sedation depth of MOAA/S	Day 0
Secondary	Deepest sedation of Bispect ral index(BIS) value	The lowest intraoperative sedation depth of BIS value	Day 0
Secondary	Recovery of orientation	Time from the end of the treatment to the recovery of orientation	Day 0
Secondary	Benzodiazepine dosage	Intraoperative benzodiazepine dosage	Day 0
Secondary	Respiratory complication occurrence rate	Respiratory complication including: intraoperative hypoxemia, respiratory depression and other complications in the two groups.	Day 0
Secondary	Discharge time	Time to be allowed to discharge after finishing the treatment	Day 0
Secondary	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
Secondary	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