Perioperative Affective Neuroscience
Conditions
Interventions
Propofol group:The propofol group received an initial dose of 1.5-2.5 mg/kg, with 20 mg top-up doses available on demand at intervals of no less than 1 minute.
Remimazolam group:The remimazolam group received an initial dose of 0.2-0.3 mg/kg, with 2.5 mg top-up doses available on demand at intervals of no less than 1 minute.
Sponsors
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients undergoing painless gastrointestinal endoscopy; 2. Aged between 18 and 65 years; 3. Body mass index (BMI) of 18–30 kg/m^2; 4. Patients with ASA grade I-II; 5. The subject can understand the whole process of this clinical study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergy to soybeans, egg yolk, or documented allergy to propofol; 2. Lipid metabolism disorders; 3. Potential difficult airway; 4. Pregnancy or lactation; 5. Asthma, recent (within 2 weeks) respiratory infection, or fever; 6. Severe metabolic diseases involving the heart, lungs, brain, liver, kidneys, etc; 7. Uncontrolled hypertension (SBP >= 140 mmHg and/or DBP >= 90 mmHg); 8. Implanted devices (e.g., pacemaker, intracranial electrodes); 9. History of epilepsy, psychiatric disease, or substance abuse; 10. Use of opioids or sedative drugs within the past month; 11. Other investigator-assessed ineligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-assessed emotional scores of subjects before propofol/remimazolam anesthesia and after recovery.;Euphoria scores of subjects, as measured by the Morphine-Benzedrine Group (MBG) scale, before propofol/remimazolam injection to after awakening.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Continuous EEG characteristics of subjects before injection and after recovery from propofol/remimazolam.;Dream experiences of subjects during sedation with propofol/remimazolam.;Short-term emotional state changes (assessed by GAD-7 and PHQ-9 scales) in subjects before propofol/remimazolam injection and on day 5 after the procedure.;Subject's satisfaction with the anesthesia experience during painless gastroentroscopy.; | — |
Countries
China
Contacts
Public ContactZhu Huschen
Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Outcome results
None listed