Procedural Sedation
Conditions
Interventions
Low dose group:Oral midazolam solution (0.3 mg/kg) + Intranasal dexmedetomidine spray (3 µg/kg). The dose of intranasal dexmedetomidine spray is calculated based on the actual body weight, rounding up
Medium dose group:Oral midazolam solution (0.5 mg/kg) + Intranasal dexmedetomidine spray (3 µg/kg). The dose of intranasal dexmedetomidine spray is calculated based on the actual body weight, rounding
Sponsors
Sichuan Provincial Women's and Children's Hospital
Eligibility
Sex/Gender
All
Age
0.5 Years to 6 Years
Inclusion criteria
Inclusion criteria: (1) infants aged from 6 months to 6 years old; (2) ASA grade I-III; (3) failure of conventional pacification and sedation; (4) meet the standard of fasting before anesthesia; (5) Written informed consent was obtained from the guardian.
Exclusion criteria
Exclusion criteria: (1) children who were allergic to sedative drugs or had contraindications to midazolam or dexmedetomidine; (2) children with severe respiratory tract infection or potential OSA; (3) use of sedatives and hypnotics within the past 48 hours; (4) patients who do not meet the ASA sedation criteria;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of procedural sedation within 30 minutes after drug administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| gender;Age in months;weight;height;Reason for sedation (type of examination);Assessment of the child’s airway;The child’s ASA classification;The dose of midazolam administered;The dose of dexmedetomidine administered;Records of deviations from the medication administration protocol;heart rate;blood pressure;oxygen saturation; OAA/S score;heart rate;blood pressure;oxygen saturation; OAA/S score;heart rate;blood pressure;oxygen saturation; OAA/S score;heart rate;blood pressure;oxygen saturation; OAA/S score;heart rate;blood pressure;oxygen saturation; OAA/S score;The duration from administration to the start of the examination;the duration of the examination;the duration for the child to regain consciousness after the examination;the duration from regaining consciousness to the child meeting the discharge criteria and leaving the room;the total duration of the procedural sedation;The satisfaction level of the examining physician;The satisfaction level of the child’s family;the image quality score of the examination;the child’s movement during the examination.;Whether to administer rescue inhalation of sevoflurane;The incidence of adverse events such as respiratory depression, bradycardia, emergence agitation, reflux aspiration, nausea and vomiting, and patient death.; | — |
Countries
China
Contacts
Public ContactLuo Mengzhu
Sichuan Provincial Women's and Children's Hospital
Outcome results
None listed