Clinical TrialMajor Depressive Disorder (MDD)PlaceboKetaminePlaceboKetamineUnknown status

Hyperventilation Combined With Etomidate or Ketamine Anesthesia in ECT Treatment of Major Depression

Randomized controlled study (n=48) comparing etomidate vs ketamine anesthesia with and without pre-emptive hyperventilation to assess effects on ECT seizure duration, cerebral desaturation and remission of depressive symptoms in patients with Major Depressive Disorder.

Target Enrollment
48 participants
Study Type
Phase IV interventional
Design
Randomized, double Blind

Detailed Description

This parallel, randomized trial evaluates whether pre-emptive hyperventilation (20 breaths in 30 seconds) prolongs ECT seizure duration and affects cerebral oximetry and remission of depressive symptoms in patients receiving bilateral bitemporal ECT.

Patients are randomized to etomidate (0.3 mg/kg) or ketamine (0.5–1.0 mg/kg) anesthesia, each with and without a hyperventilation manoeuvre immediately prior to the ECT stimulus; outcomes include seizure duration, cerebral desaturation, hemodynamic side effects and clinical remission.

Therapeutic rationale: hyperventilation may augment seizure duration via cerebral vasoconstriction but could increase risk of cerebral desaturation; ketamine may provide additive antidepressant benefit compared with etomidate.

Study Arms & Interventions

Etomidate

active comparator

IV etomidate (0.3 mg/kg) given immediately prior to ECT (no hyperventilation).

Interventions

  • Placebo0.3 mg/kg
    via IV• single dose

    Etomidate 0.3 mg/kg IV bolus (Amidate).

  • Compound
    via Other• single session

    Bilateral bitemporal electroconvulsive therapy (ECT) via SpECTrun 5000Q.

Ketamine

active comparator

IV ketamine (0.5–1.0 mg/kg) given immediately prior to ECT (no hyperventilation).

Interventions

  • Ketamine1 mg/kg
    via IV• single dose

    Ketamine 0.5–1.0 mg/kg IV bolus (dose range; reported as 1.0 mg/kg).

  • Compound
    via Other• single session

    Bilateral bitemporal electroconvulsive therapy (ECT).

Etomidate + hyperventilation

active comparator

IV etomidate (0.3 mg/kg) plus pre-ECT hyperventilation (20 breaths/30 s).

Interventions

  • Placebo0.3 mg/kg
    via IV• single dose

    Etomidate 0.3 mg/kg IV bolus.

  • Compound
    via Other• single session

    Hyperventilation: 20 breaths in 30 seconds by face mask immediately prior to ECT.

  • Compound
    via Other• single session

    Bilateral bitemporal electroconvulsive therapy (ECT).

Ketamine + hyperventilation

active comparator

IV ketamine (0.5–1.0 mg/kg) plus pre-ECT hyperventilation (20 breaths/30 s).

Interventions

  • Ketamine1 mg/kg
    via IV• single dose

    Ketamine 0.5–1.0 mg/kg IV bolus (dose range; reported as 1.0 mg/kg).

  • Compound
    via Other• single session

    Hyperventilation: 20 breaths in 30 seconds by face mask immediately prior to ECT.

  • Compound
    via Other• single session

    Bilateral bitemporal electroconvulsive therapy (ECT).

Participants

Ages
18 – 85
Sexes
Male & Female

Inclusion Criteria

  • Adults patients aged 18 to 85 years
  • Diagnosed with Major Depressive Disorder, unipolar or bipolar depression
  • Undergoing ECT for treatment of their symptoms
  • Currently residing in Manitoba

Exclusion Criteria

  • Relative contraindications to ECT therapy (recent MI or CVA, increased intracranial pressure, intracranial mass lesion, intracranial aneurysm, epilepsy, known cardiac arrhythmia, pheochromocytoma, pregnancy)
  • Contraindications to etomidate (sepsis, primary or secondary adrenal insufficiency, porphyria)
  • DSM-V diagnosis of a lifetime history of psychotic spectrum disorder
  • Drug or alcohol dependence, or abuse within the past 3 months
  • Soy-bean oil allergy

Study Details

Locations

Health Sciences Centre — Winnipeg, Manitoba, Canada

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