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

Early Phase 1

Not yet recruiting

• Conditions: Anxiety-depression
• Interventions: Drug: Esketamine

• Registration Number: NCT06073015
• Lead Sponsor: Henan Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Last Update Submitted: 2023-10-03
• Study Start: 2023-10-10
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-12-10
• Study Completion: 2025-02-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Esketamine	Esketamine (0.25mg/kg)

Primary Outcome Measures

Name	Time	Method
Anxiety and depression scale scores 1 month after surgery	1 month	Anxiety and depression scale scores 1 month after surgery