Clinical TrialDepressive DisordersKetaminePlaceboCompleted

Ketamine and Postoperative Depressive Symptom-PASSION

This study aims to determine whether ketamine could improve the depressive symptom of perioperative patients. It will also examine the safety for administrating ketamine as an antidepressant intraoperatively and effects on anxiety, postoperative pain, and delirium (n=84).

Target Enrollment
84 participants
Study Type
Phase II/III interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomized, parallel-group Phase II/III trial evaluating intraoperative IV ketamine (0.5 mg/kg over 40 minutes at dural opening) versus volume-matched normal saline in patients with supratentorial brain tumour and moderate–severe perioperative depressive symptoms.

Primary outcomes include change in depressive symptoms and safety of intraoperative ketamine; secondary outcomes include anxiety, postoperative pain, and delirium. Eighty-four participants were enrolled.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

IV ketamine 0.5 mg/kg at dural opening; 40-minute infusion.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Infused at dural opening over 40 minutes.

Normal saline

inactive

Volume-matched IV normal saline 0.5 ml/kg at dural opening; 40-minute infusion.

Interventions

  • Placebo0.5 ml/kg
    via IV• single dose• 1 doses total

    Volume- and duration-matched saline infusion.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Brain tumour located in the supratentorial area requiring elective craniotomy;
  • 2. Moderate to severe depressive symptoms as assessed by a qualified psychiatrist;
  • 3. Age 18–65 years;
  • 4. American Society of Anesthesiologists physical status I–III.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. History of epilepsy;
  • 2. Major depressive disorder patients receiving antidepressant therapy within 2 weeks;
  • 3. Other significant psychiatric illness;
  • 4. Drug abuse;
  • 5. History of allergy to the study drug;
  • 6. Tumour located in Wernicke area, Broca area, or frontal pole;
  • 7. Hyperthyroidism;
  • 8. Inability to cooperate with psychiatric assessments;
  • 9. Pregnant or breastfeeding women;
  • 10. Refusal to sign informed consent.

Study Details

  • Status
    Completed
  • Phase
    Phase IIPhase III
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment84 participants
  • Timeline
    Start: 2017-06-05
    End: 2018-11-20
  • Compounds
    KetaminePlacebo
  • Topic
    Depressive Disorders

Locations

Beijing TianTan Hospital — Beijing, China

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