Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy

Phase 4

Completed

• Conditions: Major Depression; Electroconvulsive Therapy
• Interventions: Drug: Ketamine; Drug: Sevoflurane

• Registration Number: NCT01870219
• Lead Sponsor: Inonu University

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 Timeline

• Study Start: 2012-02
• Primary Completion: 2013-04
• Study Completion: 2013-05
• Status Verified: 2013-06
• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-05
• Last Update Submitted: 2013-06-05
• Study First Posted: 2013-06-06
• Last Update Posted: 2013-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group K	Ketamine	In group K, ketamine was given to 1mg/kg ıv bolus.
Group S	Sevoflurane	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.

Primary Outcome Measures

Name	Time	Method
Evaluation Of QT interval	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of Tp-e interval	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	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.

Trial Locations

Locations (1)

Turgut Ozal Medical Center; 🇹🇷 Malatya, Turkey