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Completed

NCT Number: NCT01870219

Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy

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.

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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Electroconvulsive Therapy Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Turgut Ozal Medical Center

Malatya, 44315, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sevoflurane

Drug

sevoflurane was initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus was delivered

Other names: Volatile agent

ketamine

Drug

ketamine was given to 1mg/kg ıv bolus

Other names: Intravenous anesthetic agent

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

The Effects of Sevoflurane or Ketamine on QTc Interval During Electroconvulsive Therapy

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 6, 2013
Registry last updated
Jun 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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