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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04602845
Other study ID # PKUSSIRB-202056102
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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