Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy

Overview

The aim of this study was to evaluate the effect of sevoflurane or ketamine on the QTc and Tp-e interval during in patients with major depression.

Full Title of Study: “The Effects of Sevoflurane or Ketamine on QTc Interval During Electroconvulsive Therapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2013

Detailed Description

Patients enrolled in the study are randomly allocated by computer-generated random numbers to receive either sevoflurane or ketamine for their initial ECT session. They subsequently receive an alternative study drug in their next session, continuing to alternate between drugs at each session until the sixth session. In group S, sevoflurane are initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus is delivered, In group K, ketamine are given to 1mg/kg ıv bolus. Electrical stimulus is delivered via bilateral frontotemporal electrodes.The mean arterial pressure (MAP), HR, and ECG are recorded before anesthetic induction (T1), after anesthetic induction (T2) and at 0, 1, 3, 10 min after the seizure ended (T3, T4, T5 and T6, respectively).The QT interval and Tp-e interval are measured by one author, who was unaware of group allocation.

Interventions

  • Drug: Sevoflurane
    • sevoflurane was initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus was delivered
  • Drug: Ketamine
    • ketamine was given to 1mg/kg ıv bolus

Arms, Groups and Cohorts

  • Active Comparator: Group S
    • In group S, sevoflurane was initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus was delivered, at which time it was turned off.
  • Active Comparator: Group K
    • In group K, ketamine was given to 1mg/kg ıv bolus.

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation Of QT interval
    • Time Frame: 10 minutes
    • ECG were recorded before anesthetic induction (T1), after anesthetic induction (T2) and at 0, 1, 3, 10 min after the seizure ended (T3, T4, T5 and T6, respectively)during ECT anesthesia with sevoflurane and ketamine.The QT interval was measured by one author, who was unaware of group allocation.

Secondary Measures

  • Evaluation of Tp-e interval
    • Time Frame: 10 minutes
    • ECG were recorded before anesthetic induction (T1), after anesthetic induction (T2) and at 0, 1, 3, 10 min after the seizure ended (T3, T4, T5 and T6, respectively)during ECT anesthesia with sevoflurane and ketamine.The Tp-e interval was measured by one author, who was unaware of group allocation.
  • Seizure durations
    • Time Frame: 120 seconds
    • The duration of the EEG seizure was recorded from the EEG trace, and the peak heart rate (HR) during the convulsion was recorded from the ECG.

Participating in This Clinical Trial

Inclusion Criteria

  • Unpremedicated – American Society of Anesthesiologists (ASA) I-II the patients – Major depressions patients scheduled for ECT sessions Exclusion Criteria:

  • pregnant – with permanent pacemakers, – diabetes mellitus, – atrial fibrillation, – electrolyte imbalance, – patients taking antiarrhythmics and β-blockers.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Inonu University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Feray Erdil, MD – Inonu University
  • Overall Official(s)
    • Feray Erdil, MD, Principal Investigator, Associated Prof Dr

References

Erdil F, Demirbilek S, Begec Z, Ozturk E, Ersoy MO. Effects of propofol or etomidate on QT interval during electroconvulsive therapy. J ECT. 2009 Sep;25(3):174-7. doi: 10.1097/YCT.0b013e3181903fa5.

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