Dental anxiety
Conditions
Interventions
A Group:Age (18~44y):Intravenous injection of esketamine 0.1mg/kg, sequential corresponding dose of remimazolam (injection time 5min)
B Group:Age (45~59y):Intravenous injection of esketamine 0.1mg/kg, sequential corresponding dose of remimazolam (injection time 5min)
C Group:Age (60~74y):Intravenous injection of esketamine 0.1mg/kg, sequential corresponding dose of remimazolam (injection time 5min)
Sponsors
The Eighth Affiliated Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1. Modified Dental Anxiety Scale (MDAS) score>=12 points; 2. Patients undergoing outpatient oral treatment; 3. Age (18~74y); 4. Body mass index: 18.5~30 kg.m^2; 5. ASA Grading I-II;
Exclusion criteria
Exclusion criteria: 1. Patients with a history of heavy alcohol consumption, alcohol or drug dependence; 2. Patients who regularly use benzodiazepines; 3. Patients with contraindications to benzodiazepines; 4. Patients with severe mental illness; 5. Patients with severe cardiovascular, pulmonary, hepatic and renal dysfunction or impaired adrenal cortical function; 6. Pregnant patients; 7. Patients with structural brain diseases; 8. Patients who refuse to participate or those who are not suitable to participate in this trial; 9. Patients with obstructive sleep apnea-hypopnea syndrome or respiratory difficulties.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Within 5 min after the start of administration, the sedation level reaches the remimazolam dose of MOAA/S = 4; | — |
Secondary
| Measure | Time frame |
|---|---|
| Montgomery Depression Rating Scale scores;Modified Dental Anxiety Scale score preoperatively, postoperatively on day 1 and postoperatively day 7;dentist satisfaction;The dentist evaluated the patient's mouth opening;Adverse reactions: cardiovascular depression, respiratory depression, nausea and vomiting, restlessness during awakening (RSAS scale= 5 points), etc;Unintentional movements: gag reflex, coughing or excessive movement, etc;EEG bispectral index BIS;Total remimazolam dosage;Montgomery Depression Rating Scale score response rate;Montgomery Depression Rating Scale score remission rate;Patient satisfaction;the patient's memory of the treatment process;; | — |
Countries
China
Contacts
Public ContactZhang Yiwen
The Eighth Affiliated Hospital of Southern Medical University
Outcome results
None listed