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

Primary Purpose

Depressive Disorder

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Sevoflurane
Ketamine
Saline
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Electroconvulsive therapy; sevoflurane; ketamine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Turgut Ozal Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group SK

Group SS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean arterial pressure (MAP)
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).
Heart rate (HR)
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).

Full Information

First Posted
October 9, 2014
Last Updated
October 15, 2014
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT02267980
Brief Title
Effect of the Addition of Ketamine to Sevoflurane Anesthesia in Electroconvulsive Therapy
Official Title
Turgut Ozal Medical Center Department of Anesthesiology and Reanimation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
Electroconvulsive therapy; sevoflurane; ketamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group SK
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group SS
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Sevoflurane (sevorane)
Intervention Description
Inhalation anesthetic agent
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketamine (Ketalar) 50mg/mL injection
Intervention Description
Intravenous anesthetic agent
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Isotonic solution
Intervention Description
Isotonic solution for placebo group
Primary Outcome Measure Information:
Title
seizure duration
Description
the time from application of the ECT stimulus to the cessation of tonic-clonic motor activity in the isolated arm.
Time Frame
During electroconvulsive therapy (30 minutes)
Secondary Outcome Measure Information:
Title
Mean arterial pressure (MAP)
Description
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).
Time Frame
During Electroconvulsive therapy (30 minutes)
Title
Heart rate (HR)
Description
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).
Time Frame
During Electroconvulsive therapy (30 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feray Erdil, MD
Phone
904223410660
Ext
3148
Email
feray.erdil@inonu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmut Durmus, MD
Phone
904223410660
Ext
3105
Email
mahmut.durmus@inonu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feray Erdil, MD
Organizational Affiliation
MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turgut Ozal Medical Center
City
Malatya
ZIP/Postal Code
44315
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmut Durmus, Prof Dr
Phone
904223410660
Ext
3105
Email
mahmut.durmus@inonu.edu.tr

12. IPD Sharing Statement

Citations:
PubMed Identifier
22623080
Citation
Yalcin S, Aydogan H, Selek S, Kucuk A, Yuce HH, Karababa F, Bilgic T. Ketofol in electroconvulsive therapy anesthesia: two stones for one bird. J Anesth. 2012 Aug;26(4):562-7. doi: 10.1007/s00540-012-1378-6. Epub 2012 May 24.
Results Reference
result

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

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