Skip to main content
Clinical Trials/NCT02267980
NCT02267980
Unknown
Phase 4

Turgut Ozal Medical Center Department of Anesthesiology and Reanimation

Inonu University1 site in 1 country60 target enrollmentJuly 2014

Overview

Phase
Phase 4
Intervention
Sevoflurane
Conditions
Depressive Disorder
Sponsor
Inonu University
Enrollment
60
Locations
1
Primary Endpoint
seizure duration
Last Updated
11 years ago

Overview

Brief Summary

The investigators evaluate the effects of a subanesthetic dose of ketamine, administered as an adjunct to sevoflurane, on duration of seizure activity, hemodynamic profile and recovery times during electroconvulsive therapy (ECT) in patients with major depression.

Detailed Description

Patients will randomly allocate, to either a sevoflurane-ketamine (Group SK), sevoflurane-saline (Group SS) receiving group. Mean arterial pressure (MAP) and heart rate (HR) will record prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively). Motor and EEG seizure durations will be recorded.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
October 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Feray Erdil

Associated Professor

Inonu University

Eligibility Criteria

Inclusion Criteria

  • Major depressive patients

Exclusion Criteria

  • Pregnancy
  • Have a history of myocardial infarction in the previous six months
  • Atrial fibrillation or flutter
  • Heart block
  • Unregulated hypertension
  • Cerebrovascular diseases
  • A known drug allergy

Arms & Interventions

Group SK

Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Following loss of consciousness ketamine was administered to Group SK (n=29) in the form of a 0.5mg/kg iv bolus. Patients in Group SS (n=30) received saline in the same manner.

Intervention: Sevoflurane

Group SK

Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Following loss of consciousness ketamine was administered to Group SK (n=29) in the form of a 0.5mg/kg iv bolus. Patients in Group SS (n=30) received saline in the same manner.

Intervention: Ketamine

Group SS

Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Patients in Group SS (n=30) received saline in the same manner.

Intervention: Sevoflurane

Group SS

Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Patients in Group SS (n=30) received saline in the same manner.

Intervention: Saline

Outcomes

Primary Outcomes

seizure duration

Time Frame: During electroconvulsive therapy (30 minutes)

the time from application of the ECT stimulus to the cessation of tonic-clonic motor activity in the isolated arm.

Secondary Outcomes

  • Heart rate (HR)(During Electroconvulsive therapy (30 minutes))
  • Mean arterial pressure (MAP)(During Electroconvulsive therapy (30 minutes))

Study Sites (1)

Loading locations...

Similar Trials