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

Zhengzhou University

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Anxiety-depression

Treatments

Drug: Esketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT06073015

henanLYH

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

8 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

8 years ≤ age ≤17 years;
Patients who plan to undergo elective surgery under general anesthesia, and the operation time is ≥2h;
ASA grade I-II

Exclusion criteria

Patients expected to be admitted to ICU after surgery;
Patients who need to return to the ward with tracheal intubation after surgery;
Allergic to the active ingredients or excipients of isketamine hydrochloride injection;
Patients with severe consciousness disorder or mental system disease (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
Patients with congenital heart disease and severe developmental delay;
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;
Previous history of ketamine abuse or dependence, drug or alcohol dependence for more than 6 months, previous ketamine ineffective tests or adverse reactions.