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

NCT06073015 | Unknown Early Phase 1

• 1 other identifier: henanLYH
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anxiety-depression

Outcome Measures

Primary Outcomes (1)

• Anxiety and depression scale scores 1 month after surgery

  Anxiety and depression scale scores 1 month after surgery

  1 month

Study Arms (2)

Experimental group

EXPERIMENTAL

Esketamine (0.25mg/kg)

Drug: Esketamine

Control group

NO INTERVENTION

the same volume of normal saline

Interventions

Esketamine DRUG

Group S received a subanesthetic dose of esketamine 0.2mg/kg (2ml/50 mg) 5 minutes before the procedure began.

Experimental group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

MeSH Terms

Interventions

Esketamine

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: October 10, 2023
• Primary Completion: December 10, 2024
• Study Completion: February 10, 2025
• Last Updated: October 10, 2023

Record last verified: 2023-10