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Effects of oral midazolam combined with intranasal dexmedetomidine on preoperative sedation and postoperative recovery of preschoolers

Effects of oral midazolam combined with intranasal dexmedetomidine on preoperative sedation and postoperative recovery of preschoolers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065568
Enrollment
Unknown
Registered
2022-11-08
Start date
2022-11-09
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preoperative sedation of children

Interventions

M group:0.75mg/kg oral midazolam
D group:2ug/kg intranasal dexmedetomidine
MD group: 0.75mg/kg oral midazolam plus 1ug/kg intranasal dexmedetomidine

Sponsors

The Second Affiliated Hospital of Shantou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. ASA physical status I or II 2. aged 2-6 years 3. Lower abdomen or perineum surgery, the operation time is less than 60 minutes 4. BMI 18.5-23.9 5. The guardian of the child is informed of the study and signs the informed consent form

Exclusion criteria

Exclusion criteria: 1. known allergic to benzodiazepines, opioids, dexmedetomidine, propofol 2. respiratory infections 3. patients with severe heart, brain, liver, kidney and metabolic diseases 4. emergency surgery 5. gastrointestinal diseases 6. nasal mucosa injury

Design outcomes

Primary

MeasureTime frame
satisfactory sedation rate;

Secondary

MeasureTime frame
onset time;Ramsay sedation scale;satisfactory induction rate;Wake Up Time;incidence of PAED;

Countries

China

Contacts

Public ContactYongfa Zhang

The Second Affiliated Hospital of Shantou University Medical College

richer_cheung@foxmail.com+86 13750453746

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026