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The effect of oral esketamine-midazolam for preoperative sedation in children undergoing general anesthesia

The effect of oral esketamine-midazolam for preoperative sedation in children undergoing general anesthesia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076991
Enrollment
Unknown
Registered
2023-10-26
Start date
2023-11-06
Completion date
Unknown
Last updated
2023-10-30

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

Conditions

None listed

Interventions

M:oral sweet water and midazolam( 0.5mg/kg)
E:oral sweet water and esketamine(2mg/kg)
ME:oral sweet water, midazolam(0.5mg/kg )and esketamine(2mg/kg)

Sponsors

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1) ASA I to II; 2) Aged 1 to 6 years; 3) Elective non cardiothoracic and brain surgery with an operating time of no more than 2 hour ; 4) Meets weight standards; 5) Voluntary participation in the trial and signing of the informed consent statement.

Exclusion criteria

Exclusion criteria: 1) There is known psychiatric disorders and cognitive impairment; 2) There is known difficult airway; 3) There are pulmonary diseases; 4) There are abnormal functions of nervous system, cardiovascular system, endocrine system and liver and kidney; 5) There is a history of allergy to the drug studied; 6) There is a history of general anesthesia within 2 weeks.

Design outcomes

Primary

MeasureTime frame
The time to achieve a satisfactory level of sedation;intravenous puncture score;Sedation success rate;Mask acceptance;Post Hospitalization BehaviorQuestionnaire for Ambulatory Surgery;adverse reaction;

Secondary

MeasureTime frame
The modified yale preoperative anxiety scale,m-YPAS;Parental separation anxiety score;Anesthesiologist induced satisfaction;Pediatric anesthesia emergence delirium;

Countries

China

Contacts

Public ContactHan Lin

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

nanlinhannansh@qq.com+86 158 6871 0831

Outcome results

None listed

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