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

Primary Purpose

Anxiety-depression

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Esketamine
Sponsored by
Henan Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety-depression

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental group

    Control group

    Arm Description

    Esketamine (0.25mg/kg)

    the same volume of normal saline

    Outcomes

    Primary Outcome Measures

    Anxiety and depression scale scores 1 month after surgery
    Anxiety and depression scale scores 1 month after surgery

    Secondary Outcome Measures

    Full Information

    First Posted
    October 3, 2023
    Last Updated
    October 3, 2023
    Sponsor
    Henan Provincial People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06073015
    Brief Title
    Effect of Esketamine on Reducing Postoperative Anxiety and Depression in Adolescent Patients
    Official Title
    Effect of Esketamine on Reducing Postoperative Anxiety and Depression in Adolescent Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 10, 2023 (Anticipated)
    Primary Completion Date
    December 10, 2024 (Anticipated)
    Study Completion Date
    February 10, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Henan Provincial People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety-depression

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Esketamine (0.25mg/kg)
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    the same volume of normal saline
    Intervention Type
    Drug
    Intervention Name(s)
    Esketamine
    Intervention Description
    Group S received a subanesthetic dose of esketamine 0.2mg/kg (2ml/50 mg) 5 minutes before the procedure began.
    Primary Outcome Measure Information:
    Title
    Anxiety and depression scale scores 1 month after surgery
    Description
    Anxiety and depression scale scores 1 month after surgery
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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