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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

Tracking Information
First Submitted Date  ICMJE October 9, 2014
First Posted Date  ICMJE October 20, 2014
Last Update Posted Date October 20, 2014
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of the Addition of Ketamine to Sevoflurane Anesthesia in Electroconvulsive Therapy
Official Title  ICMJE Turgut Ozal Medical Center Department of Anesthesiology and Reanimation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder
Intervention  ICMJE
  • Drug: Sevoflurane
    Inhalation anesthetic agent
    Other Name: Sevoflurane (sevorane)
  • Drug: Ketamine
    Intravenous anesthetic agent
    Other Name: Ketamine (Ketalar) 50mg/mL injection
  • Drug: Saline
    Isotonic solution for placebo group
    Other Name: Isotonic solution
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Sevoflurane
    • Drug: Ketamine
  • 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.
    Interventions:
    • Drug: Sevoflurane
    • Drug: Saline
Publications * Yalcin S, Aydoğan H, Selek S, Kucuk A, Yuce HH, Karababa F, Bilgiç 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 15, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2014
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02267980
Other Study ID Numbers  ICMJE Inonu 2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Feray Erdil, Inonu University
Study Sponsor  ICMJE Inonu University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Feray Erdil, MD MD
PRS Account Inonu University
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP