Dental anxiety
Conditions
Interventions
R Group:Intravenous injection of the corresponding dose of normal saline (injection time 5min), remimazolam 0.08mg/kg (injection time 5min)
RE Group:Intravenous esketamine 0.2mg/kg (injection time 5 min), remimazolam 0.08 mg/kg (injection time 5 min)
Sponsors
The Eighth Affiliated Hospital , Southern Medical University (The First People's Hospital of Shunde District, Foshan City)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Modified Dental Anxiety Scale (MDAS) score >= 12 points; 2.patients undergoing outpatient oral treatment; 3.Age (18~65y); 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 or alcohol or drug dependence; 2. patients who regularly use benzodiazepines; 3.Patients with contraindications to benzodiazepines or esketamine; 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 tract difficulties.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Dental Anxiety Scale score within 2 hours after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Preoperative Modified Dental Anxiety Scale score;Visual Analogue Scale for Anxiety (VAS-A);Pain Behavior Scale (BPS);time to onset of sedation ;Satisfaction of the dentist and evaluation of the patient's mouth opening (1. Very satisfied; 2. Satisfied; 3. Neutral; 4. Dissatisfied; 5. Very dissatisfied. ), patient satisfaction, and patient memory of the treatment process;Unintentional movement: gag reflex, coughing, or excessive movement, etc;EEG bispectral index, BIS ;Total remimazolam dosage;Modified Dental Anxiety Scale score response rate;Modified Dental Anxiety Scale score remission rate;success rate of sedation;The dentist evaluates the patient's mouth opening;Patient satisfaction;Patient's memory of the treatment process;Vital signs; | — |
Countries
China
Contacts
Public ContactZhang Yiwen
The Eighth Affiliated Hospital of Southern Medical University
Outcome results
None listed