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NCT Number: NCT04602845

Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients

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.

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Key information

Conditions

Sedation Complication Midazolam Remimazolam

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University Hospital of Stomatology, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Fentanyl

Drug

50ug Fentanyl intravenously

Flurbiprofen

Drug

50mg Fentanyl intravenously

midazolam

Drug

2.5mg midazolam in 2ml normal saline intravenously

Remimazolam

Drug

3mg Remimazolam in 2ml normal saline intravenously

Primary outcomes

  1. Success rates of sedation

    Time frame: Day 0

    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.

Secondary outcomes

  1. Time to reach ideal sedation

    Time frame: Day 0

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

  2. Differences in blood pressure between the two groups

    Time frame: Day 0

    Differences in blood pressure during the operation between the two groups

  3. Differences in heart rate between the two groups

    Time frame: Day 0

    Differences in heart rate during the operation between the two groups

  4. Differences in basic vital signs between the two groups

    Time frame: Day 0

    Differences in blood pressure, heart rate, and BIS at different points during the operation between the two groups

  5. Deepest sedation of MOAA/S

    Time frame: Day 0

    The lowest intraoperative sedation depth of MOAA/S

  6. Deepest sedation of Bispect ral index(BIS) value

    Time frame: Day 0

    The lowest intraoperative sedation depth of BIS value

  7. Recovery of orientation

    Time frame: Day 0

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

  8. Benzodiazepine dosage

    Time frame: Day 0

    Intraoperative benzodiazepine dosage

  9. Respiratory complication occurrence rate

    Time frame: Day 0

    Respiratory complication including: intraoperative hypoxemia, respiratory depression and other complications in the two groups.

  10. Discharge time

    Time frame: Day 0

    Time to be allowed to discharge after finishing the treatment

  11. The Hopkins Language Learning Test score

    Time frame: Day 0

    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.

  12. Usage rate of flumazenil

    Time frame: Day 0

    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.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 26, 2020
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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