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

NCT ID: NCT06073015

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2025-02-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Esketamine (0.25mg/kg)

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

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

Control group

the same volume of normal saline

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Esketamine

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

henanLYH

Identifier Type: -

Identifier Source: org_study_id