Clinical TrialAnxiety DisordersEsketaminePlaceboUnknown status

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

Double-blind, randomised, controlled perioperative trial (n=200) evaluating a single subanesthetic esketamine dose to reduce postoperative anxiety and depression in adolescents undergoing elective surgery.

Target Enrollment
200 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

Prospective, double-blind, randomised, parallel-group trial in adolescents undergoing elective surgery; esketamine given shortly before incision versus normal saline.

Outcomes include postoperative incidence and severity of anxiety and depression, perioperative vital signs, and inflammatory markers (IL-6, CRP) collected during surgery.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Esketamine

experimental

Single perioperative subanesthetic esketamine dose given before surgery.

Interventions

  • Esketamine0.2 mg/kg
    via IV• single dose• 1 doses total

    Given 5 minutes before procedure; registry text also lists 0.25 mg/kg in another place.

Placebo (saline)

inactive

Normal saline, same volume as esketamine.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Normal saline, same volume as active.

Participants

Ages
8 – 18
Sexes
Male & Female

Inclusion 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

  • 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 Details

  • Status
    Unknown status
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment200 participants
  • Timeline
    Start: 2023-10-10
    End: 2025-02-10
  • Compounds
    EsketaminePlacebo
  • Topic
    Anxiety Disorders

Locations

China

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