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Assessing the Efficacy of Intranasal Dexmedetomidine Combined with Oral Mucosal Esketamine or Intranasal Dexmedetomidine for Preoperative Sedation in Pediatric Day Surgery

Assessing the Efficacy of Intranasal Dexmedetomidine Combined with Oral Mucosal Esketamine or Intranasal Dexmedetomidine for Preoperative Sedation in Pediatric Day Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084040
Enrollment
Unknown
Registered
2024-05-09
Start date
2024-05-13
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Children undergoing day surgery

Interventions

group of intranasal dexmedetomidine combined with oral mucosal esketamine:Children were administered a mixture of esketamine injection and monosodium syrup 0.5 mg/kg via the oral mucosa and dexmedetom
group of intranasal dexmedetomidine alone:Children were administered monosodium syrup 0.02 ml/kg via the oral mucosa and dexmedetomidine 2 µg/kg via nasal nebulization

Sponsors

Guangzhou Medical University Affiliated Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1.Children undergoing day surgery at the Guangzhou Medical University Affiliated Women and Children's Medical Center or Foshan Women and Children's Hospital; 2.Age 2-6 years old; 3.The American Society of Anesthesiologists (ASA) assessment level is level I-III;

Exclusion criteria

Exclusion criteria: 1. Obstructive sleep apnea syndrome, cardiopulmonary disease (e.g., uncorrected congenital heart disease, primary or secondary pulmonary hypertension, asthma, or structural lung disease); 2. neuromuscular disease; 3. history of psychiatric illness; 4. bradycardia; 5. hypotension; 6. ongoing treatment with digoxin, alpha-adrenergic or beta-adrenergic agonists or antagonists; 7. allergy to dexmedetomidine; 8. allergy to esketamine;

Design outcomes

Primary

MeasureTime frame
Proportion of children with UMSS greater than or equal to 2 at venipuncture;

Secondary

MeasureTime frame
Sedation onset time;Serum levels of epinephrine, norepinephrine, cortisol and blood glucose ;Occurrence of adverse reactions;numerical rating scale;Quality of sleep;

Countries

China

Contacts

Public ContactBilian Li

Guangzhou Women and Children's Medical Center

13570226780@126.com+86 135 7022 6780

Outcome results

None listed

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