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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 28, 2012

Last Updated Date

December 15, 2014

Start Date ^ICMJE

August 2011

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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

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 Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 Arm (s)

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

Enrollment ^ICMJE

Completion Date

March 2013

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.

Gender

Both

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

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

Plan to Share Data

Not Provided

IPD Description

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

Information Provided By

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

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