Effect of the Addition of Ketamine to Sevoflurane Anesthesia in Electroconvulsive Therapy

October 15, 2014 updated by: Feray Erdil, Inonu University

Turgut Ozal Medical Center Department of Anesthesiology and Reanimation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Malatya, Turkey, 44315
        • Recruiting
        • Turgut Ozal Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Sevoflurane
Inhalation anesthetic agent
Other Names:
  • Sevoflurane (sevorane)
Drug: Ketamine
Intravenous anesthetic agent
Other Names:
  • Ketamine (Ketalar) 50mg/mL injection
Placebo Comparator: 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.
Drug: Sevoflurane
Inhalation anesthetic agent
Other Names:
  • Sevoflurane (sevorane)
Drug: Saline
Isotonic solution for placebo group
Other Names:
  • Isotonic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During electroconvulsive therapy (30 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial pressure (MAP)
Time Frame: During Electroconvulsive therapy (30 minutes)
Mean arterial pressure (MAP) will be recorded 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).
During Electroconvulsive therapy (30 minutes)
Heart rate (HR)
Time Frame: During Electroconvulsive therapy (30 minutes)
Heart rate (HR) will be recorded 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).
During Electroconvulsive therapy (30 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Investigators

  • Principal Investigator: Feray Erdil, MD, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Estimate)

October 20, 2014

Last Update Submitted That Met QC Criteria

October 15, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Inonu 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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