None
Conditions
Interventions
Pre-study - Normal Weight Group:Intravenous bolus of remimazolam besylate was administered at an initial dose of 0.15 mg/kg. The dose for the next patient was determined using the modified Dixon seque
Pre-study - Overweight Group:Intravenous bolus of remimazolam besylate was administered at an initial dose of 0.15 mg/kg. The dose for the next patient was determined using the modified Dixon sequenti
Pre-study - Obese Group:Intravenous bolus of remimazolam besylate was administered at an initial dose of 0.15 mg/kg. The dose for the next patient was determined using the modified Dixon sequential me
Main Study - Individualized Guidance Group:An initial dose of remimazolam besylate determined by the individualized dosing guidance from the pre-study was administered intravenously. After 2-3 minutes
Main Study - Remimazolam Conventional Control Group:Intravenous bolus of remimazolam besylate 0.2 mg/kg (fixed dose) was administered. After 2-3 minutes, remifentanil 10 µg was given intravenously. Ga
Main Study - Propofol Conventional Control Group:Intraven
Sponsors
Baoji High-Tech Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for Phase I (Three parallel dose exploration groups): 1. Age 18-75 years; 2. Meet the criteria for normal weight group (BMI 18.5-23.9 kg/m^2), overweight group (BMI 24.0-27.9 kg/m^2), and obesity group (BMI = 28 kg/m^2), respectively; 3. Patients scheduled for elective gastroscopy; 4. ASA classification I-II, and ASA III with stable underlying disease; 5. Signed informed consent form. Inclusion criteria for Phase II (RCT validation): Only the obesity group (BMI >= 28 kg/m^2) is included; the rest are the same as above.
Exclusion criteria
Exclusion criteria: 1. Known or predicted difficult airway; 2. Long-term use of sedatives or analgesics, or history of substance abuse; 3. Pregnant or breastfeeding women; 4. Allergy to benzodiazepines or opioids (study drugs); 5. Mental, neurological, or cognitive disorders affecting communication or study compliance (including inability to complete questionnaires independently); 6. Severe cardiac, pulmonary, hepatic, or renal dysfunction (e.g., NYHA class III-IV heart failure, severe COPD, Child-Pugh class C cirrhosis), or other serious diseases deemed unsuitable for study participation by the investigator; 7. Allergy to propofol, soy, or eggs (rescue medication); 8. Use of sedatives, analgesics, or monoamine oxidase inhibitors within 72 hours before surgery; 9. History of alcoholism; 10. Presence of hearing or visual impairments affecting recovery quality assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Effective Dose (ED50) and 95% Effective Dose (ED95) of remimazolam besylate;Sedation success rate in the individualized dosing guidance group;Incidence of respiratory depression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic operating condition score;Incidence of body movement/coughing;Incidence of hypotension;Total remimazolam consumption;Recovery time;Time to achieve modified Aldrete score >= 9;Quality of Recovery-15 (QoR-15) score;Pittsburgh Sleep Quality Index (PSQI) score;Postoperative adverse events;Actigraphy sleep parameters;Patient satisfaction Visual Analog Scale (VAS) score; | — |
Countries
China
Contacts
Public ContactYanting Sun
Baoji High-Tech Hospital
Outcome results
None listed