Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboUnknown status

Effect of Subanesthetic Dose of Ketamine Combined With Propofol on Cognitive Function in Depressive Patients Undergoing Electroconvulsive Therapy

The purpose of this study is to determine whether subanesthetic dose of ketamine combined with propofol is superior to propofol anesthesia alone in improving cognitive function in depressive patients undergoing ECT

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

Detailed Description

This randomised, double-blind, parallel-group trial (n=132) compares IV ketamine 0.3 mg/kg plus propofol 1.5 mg/kg versus propofol 1.5 mg/kg plus saline in patients receiving ECT to assess cognitive outcomes.

Rationale: ECT is effective for severe depression but often causes cognitive dysfunction; preclinical and early clinical data suggest subanesthetic ketamine may protect or improve cognition when combined with anaesthesia.

Primary outcome: cognitive function rated by the Mini-Mental State Examination (MMSE); procedures include IV infusions prior to ECT with standard succinylcholine muscle relaxation and bitemporal electrode placement.

Study Arms & Interventions

Ketamine + propofol

experimental

Propofol 1.5 mg/kg plus ketamine 0.3 mg/kg administered separately by IV infusion; succinylcholine 1 mg/kg after loss of consciousness; bitemporal ECT performed.

Interventions

  • Ketamine0.3 mg/kg
    via IV• per ECT session

    IV infusion of ketamine 0.3 mg/kg

  • Compound1.5 mg/kg
    via IV• per ECT session

    Propofol 1.5 mg/kg IV (given separately)

Propofol

active comparator

Propofol 1.5 mg/kg plus normal saline (placebo) administered separately by IV infusion; succinylcholine 1 mg/kg after loss of consciousness; bitemporal ECT performed.

Interventions

  • Compound1.5 mg/kg
    via IV• per ECT session

    Propofol 1.5 mg/kg IV

  • Placebo
    via IV• per ECT session

    Normal saline [weight(kg)×0.3÷10] ml as placebo

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. diagnosed with moderate or severe depression according to Diagnostic and Statistical Manual of Mental Disorders
  • 2. aged from 18 to 65 years old

Exclusion Criteria

  • Exclusion Criteria:
  • 1. cerebrovascular malformation, arterial aneurysm, hypertension, or glaucoma;
  • 2. classification of American Society of Anesthesiologists physical status score IV or V;
  • 3. complications such as respiratory disease, cardiovascular disease, intracranial hypertension, cerebral vascular disorder;
  • 4. presence of a foreign body such as pacemaker, intracranial electrode, and clips;
  • 5. history of seizures;
  • 6. history of drug abuse;
  • 7. concomitant presence of a mental disorder;
  • 8. pregnancy;
  • 9. history of serious adverse effects related to anesthetics;
  • 10. refusal to consent for the study, or refusal to undergo one single ECT during the first week of therapy.
  • 11. hyperthyreosis

Study Details

Locations

China,Chongqing The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China

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