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Use of Ketamine vs Methohexital for Electroconvulsive Therapy (ECT) on Patient Recovery and Re-orientation Time

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ClinicalTrials.gov Identifier: NCT01567852
Recruitment Status : Completed
First Posted : March 30, 2012
Results First Posted : December 30, 2014
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
University of New Mexico

Tracking Information
First Submitted Date  ICMJE March 28, 2012
First Posted Date  ICMJE March 30, 2012
Results First Submitted Date  ICMJE May 21, 2014
Results First Posted Date  ICMJE December 30, 2014
Last Update Posted Date December 30, 2014
Study Start Date  ICMJE August 2011
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2014)
  • Re-orientation Time [ Time Frame: 1 hour ]
    Patients will be scored based on 5 questions (name, age, year, day of week, location). Each patient will be scored prior to induction as to how many questions they score correctly. Patient is deemed re-oriented when they score the same as baseline after the treatment.
  • Recovery Time [ Time Frame: 1 hour ]
    Recovery was assessed using 5 criteria (blood pressure, voluntary movement, oxygen requirement, consciousness, respiratory effort). Each criteria was scored from 0-2, with a full score of 10. The patient is scored at baseline, and is deemed recovered when all criteria has reached baseline score again.
Original Primary Outcome Measures  ICMJE
 (submitted: March 29, 2012)
  • Re-orientation Time [ Time Frame: 1 hour ]
    Patients will be reoriented to baseline status more quickly with ketamine than with methohexital
  • Recovery Time [ Time Frame: 1 hour ]
    Patients undergoing ECT treatments will recover in the post-anesthesia care unit more quickly after a ketamine induction compared to a methohexital induction
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Ketamine vs Methohexital for Electroconvulsive Therapy (ECT) on Patient Recovery and Re-orientation Time
Official Title  ICMJE The Use of Ketamine Versus Methohexital for Electroconvulsive Therapy: A Cross-Over Comparative Study on Patient Recovery and Re-Orientation Time
Brief Summary When undergoing ECT treatments, patient recovery time and re-orientation time may be shorter using ketamine for induction than using methohexital.
Detailed Description ECT treatments are done under general anesthesia, and the induction is commonly done with methohexital. We will study whether using ketamine as an induction agent will result in a faster recovery time and quicker re-orientation time compared to using methohexital.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Post-anesthesia Recovery
  • Orientation
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine (1.5mg/kg) will be given for induction, with room to titrate up to induction effect
  • Drug: Methohexital
    Methohexital (1.5mg/kg) will be given for induction
Study Arms  ICMJE
  • Experimental: Ketamine First
    This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine
    Interventions:
    • Drug: Ketamine
    • Drug: Methohexital
  • Experimental: Methohexital First
    This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital.
    Interventions:
    • Drug: Ketamine
    • Drug: Methohexital
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2014)
20
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2012)
30
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients eligible for ECT with a primary mood disorder (bipolar disorder, major depressive disorder) will be eligible to participate in this study. - Patients must have decisional capacity and must be able to consent for this study.

Exclusion Criteria:

  • patients with a primary psychotic disorder (schizophrenia, schizoaffective disorder); patients designated as having an American Society of Anesthesiologist (ASA) Status of greater than 3;
  • patients with a known allergic reactions to methohexital , ketamine and succinylcholine;
  • patients with current or previous history of aneurysms, intracranial bleeds, or intracranial hypertension;
  • patients with uncontrolled severe hypertension.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01567852
Other Study ID Numbers  ICMJE HRRC#: 11-236
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of New Mexico
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of New Mexico
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tony Yen, MD University of New Mexico
PRS Account University of New Mexico
Verification Date June 2014

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