Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy

I

Inonu University

Status and phase

Completed
Phase 4

Conditions

Major Depression
Electroconvulsive Therapy

Treatments

Drug: Ketamine
Drug: Sevoflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT01870219
Turgut Ozal Medical Center

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

24 participants in 2 patient groups

Group S
Active Comparator group
Description:
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.
Treatment:
Drug: Sevoflurane
Group K
Active Comparator group
Description:
In group K, ketamine was given to 1mg/kg ıv bolus.
Treatment:
Drug: Ketamine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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