Clinical TrialMajor Depressive Disorder (MDD)KetamineKetaminePlaceboCompleted

Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery

Double-blind, randomised clinical trial (n=45) comparing intraoperative ketamine infusion (0.5 mg/kg over 40 minutes) versus saline in patients with major depressive disorder undergoing non-cardiac surgery.

Target Enrollment
45 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

This study examined whether a perioperative intravenous ketamine infusion given as part of anaesthesia produces antidepressant effects compared with volume-matched normal saline in patients with Major Depressive Disorder undergoing non-cardiac surgery.

Ketamine was administered as a single 0.5 mg/kg infusion over 40 minutes during surgery; outcomes include depressive symptom change and perioperative morbidity.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine (double blind)

experimental

Intravenous ketamine infusion (double-blind arm).

Interventions

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

    Infusion over 40 minutes (0.5 mg/kg).

Ketamine (open label)

experimental

Intravenous ketamine infusion (open-label arm).

Interventions

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

    Infusion over 40 minutes (0.5 mg/kg).

Placebo (saline)

inactive

Volume-matched normal saline infusion (double-blind placebo comparator).

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Normal saline infusion over 40 minutes, volume-matched to ketamine.

Participants

Ages
18 – 80
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Patient presenting for non-cardiac, non-intracranial surgery
  • Major Depressive Disorder

Exclusion Criteria

  • Exclusion Criteria:
  • Pregnant or breastfeeding women

Study Details

Locations

Stanford University — Stanford, California, United States

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