Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy

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

Tracking Information

• First Submitted Date: June 3, 2013
• First Posted Date: June 6, 2013
• Last Update Posted Date: June 6, 2013
• Study Start Date: February 2012
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Major Depression
• Electroconvulsive Therapy

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 5, 2013): 24
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2013
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT01870219
• Other Study ID Numbers: Turgut Ozal Medical Center
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Feray Erdil, Inonu University
• Study Sponsor: Inonu University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Feray Erdil, MD; Associated Prof Dr

• PRS Account: Inonu University
• Verification Date: June 2013