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Unknown statusEarly Phase 1

Effect of Esketamine on Reducing Postoperative Anxiety and Depression in Adolescent Patients

NCT06073015 · Henan Provincial People's Hospital

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
200
Target enrolment
Study sites

What it is testing

Summary

This study intends to conduct a prospective, double-blind, randomized, controlled trial. Adolescents aged 8-17 years old are selected as subjects. Esketamine is used as intervention before surgery, vital signs data, serum IL-6, CRP and other inflammatory indicators are collected during surgery, and the incidence and degree of anxiety and depression are evaluated after surgery. To determine the effect of esketamine on reducing anxiety and depression in adolescents after surgery, and to provide an effective clinical basis for accelerating the rehabilitation of adolescents after 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

  • Anxiety and depression scale scores 1 month after surgery

    Measured over 1 month

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

8 Years to 18 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: 1. 8 years ≤ age ≤17 years; 2. Patients who plan to undergo elective surgery under general anesthesia, and the operation time is ≥2h; 3. ASA grade I-II Exclusion Criteria: 1. Patients expected to be admitted to ICU after surgery; 2. Patients who need to return to the ward with tracheal intubation after surgery; 3. Allergic to the active ingredients or excipients of isketamine hydrochloride injection; 4. Patients with severe consciousness disorder or mental system disease (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction; 5. Patients with congenital heart disease and severe developmental delay; 6. Patients with one of the following contraindications to esketamine :(a) patients at risk of a significant increase in blood pressure or intracranial pressure; (b) Patients with ocular hypertension (glaucoma) or penetrating ocular trauma; (c) Patients with poorly controlled or untreated hypertension (resting systolic blood pressure greater than 180 mmHg or resting diastolic blood pressure greater than 100 mmHg); (d) Untreated or undertreated hyperthyroidism; 7. Previous history of ketamine abuse or dependence, drug or alcohol dependence for more than 6 months, previous ketamine ineffective tests or adverse reactions.

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.

NCT06073015 on ClinicalTrials.gov →

Last updated in the registry 2023-10-10. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance