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The Effects of Remifentanil on Attenuating the Hemodynamic Responses After Electroconvulsive Therapy

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ClinicalTrials.gov Identifier: NCT02271555
Recruitment Status : Unknown
Verified October 2014 by Feray Erdil, Inonu University.
Recruitment status was:  Not yet recruiting
First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
Feray Erdil, Inonu University

Tracking Information
First Submitted Date  ICMJE October 16, 2014
First Posted Date  ICMJE October 22, 2014
Last Update Posted Date October 22, 2014
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2014)
The effects of remifentanil on the heart rate after electroconvulsive therapy [ Time Frame: 20 minute ]
Prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2014)
  • Seizure duration [ Time Frame: 20 minute ]
    During electroconvulsive therapy
  • The effects of remifentanil on the mean arterial pressure after electroconvulsive therapy [ Time Frame: 20 minute ]
    Prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have 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 The Effects of Remifentanil on Attenuating the Hemodynamic Responses After Electroconvulsive Therapy
Official Title  ICMJE Inonu University, Turgut Ozal Medical Center, Department of Anesthesiology and Reanimation Malatya
Brief Summary The investigators will be evaluated the effects of a single loading dose of remifentanil (1µg/kg), administered as an adjunct to sevoflurane, on duration of hemodynamic profile, seizure activity, and recovery times during electroconvulsive therapy (ECT) in patients with major depression
Detailed Description Major depressive patients will enrolled this trial. Mean arterial pressure (MAP) and heart rate (HR) and peripheral oxygen saturation values will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively). The peak heart rate during the seizure will be recorded from the Electrocardiogram.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Haemodynamic Rebound
Intervention  ICMJE
  • Drug: Sevoflurane
    Anesthetic induction will be achieved via 8% sevoflurane
    Other Name: Sevorane
  • Drug: Remifentanil
    After the loss of consciousness remifentanil will be administered to Group sevoflurane-remifentanil in the form of a 1 µg/kg intravenous bolus.
    Other Name: Ultiva
  • Drug: Saline
    After the loss of consciousness saline will be administered to Group sevoflurane-saline intravenous bolus.
    Other Name: 0.9% isotonic solution
Study Arms  ICMJE
  • Active Comparator: sevoflurane-remifentanil (Group SR)
    Sevoflurane will be initiated, at 8% for anesthesia induction until loss of consciousness will achieve, at which point it will be discontinued. After the loss of consciousness remifentanil will be administered to Group sevoflurane-remifentanil in the form of a 1 µg/kg intravenous bolus.
    Interventions:
    • Drug: Sevoflurane
    • Drug: Remifentanil
  • Placebo Comparator: sevoflurane-saline (Group SS)
    Sevoflurane will be initiated, at 8% for anesthesia induction until loss of consciousness will achieve, at which point it will be discontinued. Placebo is 0.9% saline. After the loss of consciousness saline will be administered to Group sevoflurane-saline in the form of intravenous bolus.
    Interventions:
    • Drug: Sevoflurane
    • Drug: Saline
Publications * Nishikawa K, Higuchi M, Kawagishi T, Shimodate Y, Yamakage M. Effect of divided supplementation of remifentanil on seizure duration and hemodynamic responses during electroconvulsive therapy under propofol anesthesia. J Anesth. 2011 Feb;25(1):29-33. doi: 10.1007/s00540-010-1049-4. Epub 2010 Nov 30.

*   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 20, 2014)
58
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Major depressive patients

Exclusion Criteria:

  • younger than 18 years, pregnant, had a history of myocardial infarction in the previous six months, atrial fibrillation or flutter, heart block, unregulated hypertension, cerebrovascular diseases, known drug allergy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (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 NCT02271555
Other Study ID Numbers  ICMJE Inonu 3
Has Data Monitoring Committee No
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 İnonu Univercity Medical Faculty Department of Anestheisology and Reanimation
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