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

Tracking Information
First Submitted Date ICMJE	March 28, 2012
First Posted Date ICMJE	March 30, 2012
Results First Submitted Date	May 21, 2014
Results First Posted Date	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	Complete list of historical versions of study NCT01567852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	University of New Mexico
Study Sponsor ICMJE	University of New Mexico
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