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Application of Dexmedetomidine Intranasal Spray Sedation Guided by EEG Analysis Technology in Pediatric Dental Treatment

Application of Dexmedetomidine Intranasal Spray Sedation Guided by EEG Analysis Technology in Pediatric Dental Treatment

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105852
Enrollment
Unknown
Registered
2025-07-14
Start date
2025-07-14
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Dental caries in children

Interventions

Group B:Administer an intranasal dose of 2.5 µg/kg of dexmedetomidine (DEX)
Group C:Administer an intranasal dose of 3.0 µg/kg of dexmedetomidine (DEX)
Group A:Administer an intranasal dose of 2.0 µg/kg of dexmedetomidine (DEX)

Sponsors

Stomatological Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1.Children aged 2 to 6 years old, who are scheduled to receive general anesthesia for dental treatment in our hospital and whose American Society of Anesthesiologists (ASA) physical status classification is grade I to II;

Exclusion criteria

Exclusion criteria: 1. Without consent. 2. Allergic to dexmedetomidine (DEX). 3. Nasal discharge (that is, running nose). 4. Renal or hepatic dysfunction. 5. Any severe systemic disease or fever.

Design outcomes

Primary

MeasureTime frame
Electroencephalogram characteristics;

Secondary

MeasureTime frame
Vital signs;Face mask acceptance score;adverse effect;MOAA/S score;Emergence Agitation Score;Ramsay sedation score;mYPAS score;

Countries

China

Contacts

Public ContactSisi Li

Stomatological Hospital of Chongqing Medical University

500940@hospital.cqmu.edu.cn+86 152 2334 0305

Outcome results

None listed

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