preoperative anxiety and sedation
Conditions
Interventions
Midazolam Hydrochloride Oral Solution Group:None
Sponsors
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
0.5 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 6 months and 16 years (inclusive), either sex. 2.Scheduled for elective surgery (e.g., in general surgery, urology, orthopedics, otorhinolaryngology, or stomatology) requiring preoperative sedative medication. 3.Legal guardian and/or the patient (where applicable) provided consent to participate in the trial and voluntarily signed the informed consent form. (Legal guardians signed the guardian version; children aged 8 years or older also provided assent by signing a minor-specific informed consent form).
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to any component of midazolam oral solution. 2.Diagnosis of acute angle-closure glaucoma or inadequately treated open-angle glaucoma. 3.Concurrent participation in another interventional clinical trial. 4.Considered by the investigator to be unsuitable for participation for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anxiety and Ramsay Sedation Scores in Children in the Midazolam Hydrochloride Oral Solution Group at the Following Time Points: 1 hour before drug administration (T0) Every 5–10 minutes after administration (T1, T2, T3, T4, T5);Children's Cooperation Score During Anesthesia Induction;Satisfaction of Postoperative Pediatric Caregivers and Anesthesiologists with Drug Administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pediatric PACU Recovery Time;Vital Signs in Children After Drug Administration, Including SpO? (Pulse Oximetry), Respiratory Rate, and Heart Rate; | — |
Countries
China
Contacts
Public ContactTang Xiaolin
Department of Anesthesiology, Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Outcome results
None listed