NCT01870219

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

June 3, 2013

Last Update Submit

June 5, 2013

Conditions

Keywords

sevofluraneketamineQT interval

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Evaluation of Tp-e interval

    10 minutes

  • Seizure durations

    120 seconds

Study Arms (2)

Group S

ACTIVE COMPARATOR

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.

Drug: Sevoflurane

Group K

ACTIVE COMPARATOR

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

Drug: Ketamine

Interventions

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

Also known as: Volatile agent
Group S

ketamine was given to 1mg/kg ıv bolus

Also known as: Intravenous anesthetic agent
Group K

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unpremedicated
  • American Society of Anesthesiologists (ASA) I-II the patients
  • Major depressions patients scheduled for ECT sessions

You may not qualify if:

  • pregnant
  • with permanent pacemakers,
  • diabetes mellitus,
  • atrial fibrillation,
  • electrolyte imbalance,
  • patients taking antiarrhythmics and β-blockers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turgut Ozal Medical Center

Malatya, 44315, Turkey (Türkiye)

Location

Related 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.

    PMID: 19225403BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

SevofluraneKetamine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, Cyclic

Study Officials

  • Feray Erdil, MD

    Associated Prof Dr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 6, 2013

Study Start

February 1, 2012

Primary Completion

April 1, 2013

Study Completion

May 1, 2013

Last Updated

June 6, 2013

Record last verified: 2013-06

Locations