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CompletedEarly Phase 1

S-ketamin Premedication in Pediatric EENT Surgery

NCT04757675 · Eye & ENT Hospital of Fudan University

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
320
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

We aim to investigate the effects of premedication (intranasal or intravenous administration) of s-ketamin, dexmedetomidine, and combination for premedication in children undergoing ENT surgery.

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

  • The modified Yale Preoperative Anxiety Scale

    Measured over 1 min after premedication

  • The modified Yale Preoperative Anxiety Scale

    Measured over 5 min after premedication

  • The modified Yale Preoperative Anxiety Scale

    Measured over 10 min after premedication

  • The modified Yale Preoperative Anxiety Scale

    Measured over 20 min after premedication

  • The modified Yale Preoperative Anxiety Scale

    Measured over 30 min after premedication

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

2 Years to 12 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * After obtaining the informed consent from their parents or proxies, the children aged 2 to 12 years, scheduled for elective ENT surgery, of American Society of Anesthesiologists (ASA) I or II were enrolled in this study. Exclusion Criteria: * Congenital heart diseases, congenital dysplasia, obstructive sleep apnea syndrome, upper respiratory tract infection, body mass index (BMI) ≥25, allergy to S-ketamin or dexmedetomidine, and severe liver or kidney disease.

Where

1 study site

FacilityCityRegionCountry
Eye and ENT Hospital of Fudan UniversityShanghai—China

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.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04757675 on ClinicalTrials.gov →

Last updated in the registry 2022-04-27. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance