Clinical TrialDepressive DisordersEsketaminePlaceboUnknown status

Intravenous Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery

Randomised, parallel-group prevention trial (n=80) testing a single low-dose IV esketamine infusion (0.3 mg/kg over 40 min) versus saline to prevent postoperative depression after cardiac surgery.

Target Enrollment
80 participants
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

This randomised, quadruple-blind, parallel-group study evaluates whether a single subanaesthetic intravenous esketamine infusion (0.3 mg/kg, infused over 40 minutes before anaesthesia) prevents or mitigates postoperative depressive symptoms in patients undergoing cardiac surgery.

Primary purpose is prevention; outcomes include incidence and severity of postoperative depression assessed by qualified psychiatric clinicians with follow-up assessments. Estimated enrollment is 80 participants.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Esketamine

experimental

Low-dose esketamine infusion 40 minutes before anaesthesia induction.

Interventions

  • Esketamine0.3 mg/kg
    via IV• single dose• 1 doses total

    0.3 mg/kg diluted in 100 ml saline, infused over 40 minutes before induction.

Placebo (saline)

inactive

Normal saline infusion as placebo comparator.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Normal saline infusion (40 ml) over 40 minutes before induction.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Patients scheduled for heart surgery
  • Moderate to severe depressive symptom measured by the qualified psychiatric doctors
  • Over 18 years of age
  • American Society of Anesthesiologists physical status I-III

Exclusion Criteria

  • Exclusion Criteria:
  • History of epilepsy
  • Major depression disorder patients undergoing antidepressive therapy within 2 weeks
  • Psychiatric illness
  • Drug abuse
  • History of allergy to esketamine
  • Hyperthyroidism
  • Patients can not cooperate with investigators on psychiatric assessments
  • Pregnant or breastfeeding woman
  • Refuse to sign informed consent.

Study Details

  • Status
    Unknown status
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment80 participants
  • Timeline
    Start: 2021-12-01
    End: 2022-12-15
  • Compounds
    EsketaminePlacebo
  • Topic
    Depressive Disorders

Locations

Beijing Chaoyang Hospital, Capital Medical University — Beijing, Beijing Municipality, China
Beijing Chaoyang Hospital — Beijing, Beijing Municipality, China

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