Patients undergoing general anesthesia surgery
Conditions
Interventions
M1:Oral Midazolam oral solution 7.5mg
M2:Oral Midazolam oral solution 10mg
M3:Oral Midazolam oral solution 12.5mg
control group:Oral equidose placebo
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria (1) Age 18-65 years old; (2) Deviation from ideal body weight = 25%; (3) American Association of Anesthesiologists ASA I-II; (4) The operation duration is less than 2h (such as Appendectomy, induced abortion, hernia repair and other short operations); (5) No history of long-term use of analgesic, sedative and anti anxiety drugs in the past; (6) Informed consent, voluntarily participate in the experiment and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria (1) Patients with known Drug allergy to Midazolam or benzodiazepine, acute closed eye glaucoma or open angle glaucoma without effective treatment; (2) Weight exceeds ideal weight by ± 25%; (3) Patients with any serious systemic organ disease (heart lung/kidney/liver), Nervous system disease (cerebral palsy, autism, etc.), or combined use of Anesthetic or other central nervous system inhibitors; (4) Patients who have taken any drugs that may interfere with the pharmacokinetics or pharmacodynamics of Midazolam, such as Antifungal, Macrolide antibiotics, Cimetidine, rifamycin or Calcium channel blockers; (5) Patients with communication barriers, cognitive impairment, and a history of mental illness; (6) Pregnant women; (7) Subjects deemed unsuitable by the researchers for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time for Ramsay Sedation Scale = 3; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anxiety Visual Simulation Anxiety Level;Preoperative anxiety level in Amsterdam;Preoperative anxiety level;Ramsay Sedation Scale calmness level;Heart rate;blood oxygen saturation;blood pressure;Anesthetic usage;Satisfaction;Pre operative knowledge level in Amsterdam; | — |
Countries
People's Republic of China
Contacts
Public ContactGuanghong Xu
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed