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

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ClinicalTrials.gov Identifier: NCT02267980
Recruitment Status : Unknown
Verified October 2014 by Feray Erdil, Inonu University.
Recruitment status was:  Recruiting
First Posted : October 20, 2014
Last Update Posted : October 20, 2014
Sponsor:
Information provided by (Responsible Party):
Feray Erdil, Inonu University

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Drug: Sevoflurane Drug: Ketamine Drug: Saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Turgut Ozal Medical Center Department of Anesthesiology and Reanimation
Study Start Date : July 2014
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

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 Name: Sevoflurane (sevorane)

Drug: Ketamine
Intravenous anesthetic agent
Other Name: 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 Name: Sevoflurane (sevorane)

Drug: Saline
Isotonic solution for placebo group
Other Name: Isotonic solution




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).

  2. 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).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267980


Contacts
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Contact: Feray Erdil, MD 904223410660 ext 3148 feray.erdil@inonu.edu.tr
Contact: Mahmut Durmus, MD 904223410660 ext 3105 mahmut.durmus@inonu.edu.tr

Locations
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Turkey
Turgut Ozal Medical Center Recruiting
Malatya, Turkey, 44315
Contact: Mahmut Durmus, Prof Dr    904223410660 ext 3105    mahmut.durmus@inonu.edu.tr   
Sponsors and Collaborators
Inonu University
Investigators
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Principal Investigator: Feray Erdil, MD MD

Publications of Results:
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Responsible Party: Feray Erdil, Associated Professor, Inonu University
ClinicalTrials.gov Identifier: NCT02267980     History of Changes
Other Study ID Numbers: Inonu 2
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: October 20, 2014
Last Verified: October 2014
Keywords provided by Feray Erdil, Inonu University:
Electroconvulsive therapy; sevoflurane; ketamine
Additional relevant MeSH terms:
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Depressive Disorder
Mood Disorders
Mental Disorders
Ketamine
Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Anesthetics, Inhalation