Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870219
• Other study ID #: Turgut Ozal Medical Center
• 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

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Electroconvulsive Therapy
• Major Depression

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