Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy
Primary Purpose
Major Depression, Electroconvulsive Therapy
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Sevoflurane
Ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression focused on measuring sevoflurane, ketamine, QT interval
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.
Sites / Locations
- Turgut Ozal Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group S
Group K
Arm Description
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.
In group K, ketamine was given to 1mg/kg ıv bolus.
Outcomes
Primary Outcome Measures
Evaluation Of QT interval
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 Outcome Measures
Evaluation of Tp-e interval
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01870219
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Electroconvulsive Therapy
Keywords
sevoflurane, ketamine, QT interval
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group S
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group K
Arm Type
Active Comparator
Arm Description
In group K, ketamine was given to 1mg/kg ıv bolus.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Volatile agent
Intervention Description
sevoflurane was initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus was delivered
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Intravenous anesthetic agent
Intervention Description
ketamine was given to 1mg/kg ıv bolus
Primary Outcome Measure Information:
Title
Evaluation Of QT interval
Description
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.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Evaluation of Tp-e interval
Description
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.
Time Frame
10 minutes
Title
Seizure durations
Description
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.
Time Frame
120 seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feray Erdil, MD
Organizational Affiliation
Associated Prof Dr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turgut Ozal Medical Center
City
Malatya
ZIP/Postal Code
44315
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
19225403
Citation
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.
Results Reference
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Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy
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