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Application of Dexmedetomidine Nasal Spray for Preoperative Sedation in Preschool Children Undergoing General Anesthesia

Application of Dexmedetomidine Nasal Spray for Preoperative Sedation in Preschool Children Undergoing General Anesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107246
Enrollment
Unknown
Registered
2025-08-07
Start date
2025-08-10
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Preoperative anxiety

Interventions

Group C:Administer 0.5 ml of saline intranasally
Group D:Administer 0.5 ml of dexmedetomidine (2.0 µg/kg, diluted to 0.5 ml with saline) intranasally
Group P:Administer the pediatric-specific dexmedetomidine nasal spray (300 µg/1 ml, 8 sprays per device) with one spray (15 µg per spray) in each nostril

Sponsors

The Affiliated Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 3 Years

Inclusion criteria

Inclusion criteria: (1) Age: 2-3 years old; (2) Weight range: 10.7-19.4 kg; (3) Pediatric patients undergoing laparoscopic high ligation of indirect inguinal hernia sac under general anesthesia; (4) ASA physical status classification: Class I-II; (5) Expected operative duration: <=2 hours; (6) Signed informed consent obtained from legal guardians.

Exclusion criteria

Exclusion criteria: (1) Allergy to dexmedetomidine, propofol, opioids or their components; (2) Children with heart rate <70 beats per minute, second- or third-degree atrioventricular block, or other cardiac diseases; (3) Patients with severe hepatic or renal dysfunction; (4) Children with respiratory diseases or upper respiratory tract infections within one week; (5) Patients with psychiatric disorders or cognitive impairment; (6) Nasal anatomical abnormalities (e.g., deviated nasal septum), recent nasal surgery or trauma.

Design outcomes

Primary

MeasureTime frame
Pediatric anxiety level;Compliance with anesthesia induction in pediatric patients;Level of agitation during the awakening period;

Countries

China

Contacts

Public ContactAn Li

The Affiliated Hospital of Guizhou Medical University

471115013@qq.com+86 139 8440 0525

Outcome results

None listed

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