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RecruitingPhase 4

Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia

NCT06853431 · Second Affiliated Hospital of Wenzhou Medical University

Recruiting
Status
Accepting participants
Phase 4
Phase
80
Target enrolment
2
Study sites
Outside the US

What it is testing

Summary

For pediatric patients undergoing general anesthesia, poor anesthesia induction compliance often has adverse effects on individual behavior in the early postoperative period. Dexmedetomidine can reduce the cardiovascular responses and postoperative mental adverse reactions caused by esketamine anesthesia induction \[6\]. This study aims to explore the ED50 and ED95 and clinical effects of the combination of dexmedetomidine and esketamine nasal drops for preoperative sedation in children of different ages undergoing general anesthesia, providing a theoretical basis for the combined use of dexmedetomidine and esketamine for preoperative sedation in children undergoing general anesthesia.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Onset time of sedation

    Measured over Within 30 minutes after intranasal administration of dexmedetomidine.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

12 Months to 72 Months
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. ASA physical status classification Grade I or II; 2. Age 1-6 years old; 3. Children who need to undergo general anesthesia for elective surgery; 4. Weight within the normal range; 5. Signed informed consent form. - Exclusion Criteria: 1. The child's guardian or the child themselves refuses to participate in the study; 2. Patients with contraindications for sedation/anesthesia or a history of abnormal recovery from sedation/anesthesia; 3. Individuals known to be allergic to the study drugs, opioid drugs, or rescue medications; 4. Individuals with a history of heart, brain, liver, kidney, or metabolic diseases; 5. Individuals with an upper respiratory tract infection within the past two weeks; 6. Individuals with other diseases that may cause harm to the subject. -

Where

2 study sites

FacilityCityRegionCountry
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical UniversityWenzhouZhejiangChina
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical UniversityWenzhouZhejiangChina

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06853431 on ClinicalTrials.gov →

Last updated in the registry 2025-12-02. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Indication

All 2 trials from Second Affiliated Hospital of Wenzhou Medical University →