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Clinical Trials/NCT01567852
NCT01567852CompletedNot Applicable

The Use of Ketamine Versus Methohexital for Electroconvulsive Therapy: A Cross-Over Comparative Study on Patient Recovery and Re-Orientation Time

University of New Mexico1 site in 1 country20 target enrollmentStarted: August 2011Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Re-orientation Time

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Ketamine First

Experimental

This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine

Intervention: Ketamine (Drug)

Ketamine First

Experimental

This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine

Intervention: Methohexital (Drug)

Methohexital First

Experimental

This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital.

Intervention: Ketamine (Drug)

Methohexital First

Experimental

This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital.

Intervention: Methohexital (Drug)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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