Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy

NCT ID: NCT01870219

Last Updated: 2013-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-05-31

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.

Conditions

Major Depression; Electroconvulsive Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: DRUG

sevoflurane was initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus was delivered

Group K

In group K, ketamine was given to 1mg/kg ıv bolus.

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

ketamine was given to 1mg/kg ıv bolus

Interventions

Sevoflurane

sevoflurane was initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus was delivered

Intervention Type: DRUG

Ketamine

ketamine was given to 1mg/kg ıv bolus

Intervention Type: DRUG

Other Intervention Names

Volatile agent; Intravenous anesthetic agent

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Feray Erdil

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feray Erdil, MD

Role: PRINCIPAL_INVESTIGATOR

Associated Prof Dr

Locations

Turgut Ozal Medical Center

Malatya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 19225403 (View on PubMed)

Other Identifiers

Turgut Ozal Medical Center

Identifier Type: -

Identifier Source: org_study_id