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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01870219
Other study ID # Turgut Ozal Medical Center
Secondary ID
Status Completed
Phase Phase 4
First received June 3, 2013
Last updated June 5, 2013
Start date February 2012
Est. completion date May 2013

Study information

Verified date June 2013
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date May 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 ß-blockers.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Turkey Turgut Ozal Medical Center Malatya

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 10 minutes Yes
Secondary 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. 10 minutes Yes
Secondary 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. 120 seconds Yes
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