Effect of the Addition of Ketamine to Sevoflurane Anesthesia in Electroconvulsive Therapy
Turgut Ozal Medical Center Department of Anesthesiology and Reanimation
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 9, 2014
CompletedFirst Posted
Study publicly available on registry
October 20, 2014
CompletedOctober 20, 2014
October 1, 2014
3 months
October 9, 2014
October 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
seizure duration
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 Outcomes (2)
Mean arterial pressure (MAP)
During Electroconvulsive therapy (30 minutes)
Heart rate (HR)
During Electroconvulsive therapy (30 minutes)
Study Arms (2)
Group SK
ACTIVE COMPARATORSevoflurane 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.
Group SS
PLACEBO COMPARATORSevoflurane 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.
Interventions
Eligibility Criteria
You may qualify if:
- Major depressive patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inonu Universitylead
Study Sites (1)
Turgut Ozal Medical Center
Malatya, 44315, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 22623080RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Feray Erdil, MD
MD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
October 9, 2014
First Posted
October 20, 2014
Study Start
July 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
October 20, 2014
Record last verified: 2014-10