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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01567852
First received: March 28, 2012
Last updated: December 15, 2014
Last verified: June 2014

March 28, 2012
December 15, 2014
August 2011
March 2013   (final data collection date for primary outcome measure)
  • Re-orientation Time [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Re-orientation Time [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Patients will be reoriented to baseline status more quickly with ketamine than with methohexital
  • Recovery Time [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Patients undergoing ECT treatments will recover in the post-anesthesia care unit more quickly after a ketamine induction compared to a methohexital induction
Complete list of historical versions of study NCT01567852 on ClinicalTrials.gov Archive Site
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Use of Ketamine vs Methohexital for Electroconvulsive Therapy (ECT) on Patient Recovery and Re-orientation Time
The Use of Ketamine Versus Methohexital for Electroconvulsive Therapy: A Cross-Over Comparative Study on Patient Recovery and Re-Orientation Time

When undergoing ECT treatments, patient recovery time and re-orientation time may be shorter using ketamine for induction than using methohexital.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Post-anesthesia Recovery
  • Orientation
  • 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
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01567852
HRRC#: 11-236
Yes
University of New Mexico
University of New Mexico
Not Provided
Principal Investigator: Tony Yen, MD University of New Mexico
University of New Mexico
June 2014

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