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Comparison of intranasal dexmedetomidine, esketamine and dexmedetomidine-esketamine for preoperative sedation in children undergoing general anesthesia: a randomized controlled, double-blind trial

Comparison of intranasal dexmedetomidine, esketamine and dexmedetomidine-esketamine for preoperative sedation in children undergoing general anesthesia: a randomized controlled, double-blind trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039445
Enrollment
Unknown
Registered
2020-10-28
Start date
2020-10-15
Completion date
Unknown
Last updated
2021-02-01

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

Conditions

None listed

Interventions

esketamine:Intranasal esketamine
Combine dexmedetomidine with esketamine:Intranasal dexmedetomidine combined with esketamine

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 surgery with an operating time of no more than 1 hour; 4) Voluntary participation in the trial and signing of the informed consent statement.

Exclusion criteria

Exclusion criteria: 1) There are congenital heart diseases; 2) There are pulmonary diseases; 3) There are nasal diseases; 4) There is known difficult airway; 5) There is a history of allergy to the drug studied.

Design outcomes

Primary

MeasureTime frame
The degree of cooperation during anesthesia induction;

Secondary

MeasureTime frame
Anxiety before induction of surgery;Parental separation anxiety score;Anesthesiologist induced satisfaction;Heart rate;Blood pressure;Pulse saturation;the University of Michigan Sedation Scale;Pediatric anesthesia emergence delirium;The face, legs, activit, cry, consolability pain scale;

Countries

China

Contacts

Public ContactHan Lin

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

nanlinhannansh@qq.com+86 15868710831

Outcome results

None listed

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