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ED50 and clinical observation of esketamine combined with dexmedetomidine for preoperative sedation in children

ED50 and clinical observation of esketamine combined with dexmedetomidine for preoperative sedation in children

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071445
Enrollment
Unknown
Registered
2023-05-16
Start date
2023-05-16
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Elective short pediatric surgery under general anesthesia

Interventions

Sponsors

Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Children undergoing elective short operation under general anesthesia (operation time <=90min); 2. ASA II-III; 3. Age 2-6 years old.

Exclusion criteria

Exclusion criteria: 1. known allergy to esketamine or dexmedetomidine; 2. Families with neurological and psychiatric diseases; 3. Combined with cardiovascular or pulmonary disease; 4. Complicated with hepatorenal insufficiency; 5. Increased intracranial pressure or ocular pressure; 6. History of hyperthyroidism; 7. Long-term use of sedative or analgesic drugs.

Design outcomes

Primary

MeasureTime frame
Esketamine dosage;Dexmedetomidine dosage;Median effective dose;Modified Observer’s Assessment of Alertness/Sedation Scale,MOAA/S;the parental separation anxiety scale,PSAS;Adverse reaction;

Secondary

MeasureTime frame
Time of onset of sedation;Awakening time ;Duration of stay in PACU;Duration of operation;Aldrete score;Heart rate ;Blood pressure ;Pulse oxygen saturation ;

Countries

China

Contacts

Public ContactYating Zeng

Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College

1045447930@qq.com+86 177 7838 1006

Outcome results

None listed

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