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Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy

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ClinicalTrials.gov Identifier: NCT01870219
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : June 6, 2013
Sponsor:
Information provided by (Responsible Party):
Feray Erdil, Inonu University

Tracking Information
First Submitted Date  ICMJE June 3, 2013
First Posted Date  ICMJE June 6, 2013
Last Update Posted Date June 6, 2013
Study Start Date  ICMJE February 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy
Official Title  ICMJE The Effects of Sevoflurane or Ketamine on QTc Interval During Electroconvulsive Therapy
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depression
  • Electroconvulsive Therapy
Intervention  ICMJE
  • Drug: Sevoflurane
    sevoflurane was initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus was delivered
    Other Name: Volatile agent
  • Drug: Ketamine
    ketamine was given to 1mg/kg ıv bolus
    Other Name: Intravenous anesthetic agent
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Sevoflurane
  • Active Comparator: Group K
    In group K, ketamine was given to 1mg/kg ıv bolus.
    Intervention: Drug: Ketamine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2013)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01870219
Other Study ID Numbers  ICMJE Turgut Ozal Medical Center
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Feray Erdil, Inonu University
Study Sponsor  ICMJE Inonu University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Feray Erdil, MD Associated Prof Dr
PRS Account Inonu University
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP