Clinical TrialMajor Depressive Disorder (MDD)PlaceboKetamineCompleted

Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy

Randomised, quadruple-blind crossover ECT study (n=24) comparing sevoflurane anaesthesia versus ketamine 1 mg/kg IV bolus on QTc and Tp-e intervals in patients with major depression.

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

Detailed Description

Patients are randomised to receive sevoflurane or ketamine for their initial ECT session and then receive the alternate agent on the next session, alternating at each session through the sixth session.

Sevoflurane is given as inhaled induction at 8% then maintained at 2–4% until the electrical stimulus; ketamine is administered as a 1 mg/kg IV bolus. ECG, MAP and HR are recorded at baseline, after induction and at 0, 1, 3 and 10 minutes post-seizure; QT and Tp-e intervals measured by a blinded assessor.

Primary aim is to compare effects of the two anaesthetic strategies on QTc and Tp-e intervals in patients undergoing ECT for major depressive disorder.

Study Protocol

Preparation

sessions

Dosing

6 sessions

Integration

sessions

Study Arms & Interventions

Sevoflurane

experimental

Sevoflurane anaesthesia for ECT (initiated at 8% for induction, maintained 2–4% until stimulus).

Interventions

  • Placebo
    via Inhalationper session

    Induction at 8% sevoflurane, maintenance 2–4% until electrical stimulus; volatile anaesthetic agent (sevoflurane).

Ketamine

active comparator

Ketamine 1 mg/kg IV bolus for ECT.

Interventions

  • Ketamine1 mg/kg
    via IVper session

    1 mg/kg IV bolus administered for anaesthesia during ECT.

Participants

Ages
1860
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Unpremedicated
  • American Society of Anesthesiologists (ASA) I–II
  • Patients with major depression scheduled for ECT sessions

Exclusion Criteria

  • Exclusion Criteria:
  • Pregnant
  • Permanent pacemaker
  • Diabetes mellitus
  • Atrial fibrillation
  • Electrolyte imbalance
  • Taking antiarrhythmics or β-blockers

Study Details

Locations

Turgut Ozal Medical CenterMalatya, Turkey (Türkiye)

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